Double-blind Comparative Study Research Articles

Randomized double blind comparative study on efficacy and safety of oral oxaceprol 200 mg versus oral diclofenac 50 mg in patients with moderate osteoarthritis

Background: Osteoarthritis of knee is the most common form of arthritis globally, approximately 250 million people are suffering from osteoarthritis of the knee alone throughout the world. It is a chronic joint disease leading to cause cartilage degradation that involves synovial Inflammation, Subchondral bone remodelling, and Formation of osteophyte pathologically, which leads to cause pain, joint destruction and difficulty in walking. Aim of the current study was to compare the safety and efficacy of oxaceprol 200 mg versus diclofenac 50 mg in patients with moderate osteoarthritis and to determine cost-effectiveness between these two drugsMethods: this is a randomized controlled study, in our study total of 94 patients were screened, of which 85 patients met inclusion & exclusion criteria. In this, 78 members gave written informed consent, they were randomly assigned by double-blind fashion into two treatment groups (oxaceprol and diclofenac). Results were analyzed by applying paired and unpaired student t-test by using SPSS softwareResults: In our study, both oxaceprol and diclofenac were extremely significant in reducing joint pain and joint stiffness and improving physical activity, but when comparing with one another oxaceprol group showed better results in improving physical activityConclusions: From our study, it is concluded that oxaceprol is equally efficacious as diclofenac in reducing knee pain, joint stiffness but more efficacious than diclofenac in improving physical activity of patients by enhancing bone remodelling.

Randomized Double-Blind Comparative Study of First Global Denosumab Biosimilar in Oncology

Abstract Purpose The aim of this study was to compare first global biosimilar denosumab for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. Methods It was a randomized, double-blind, comparative clinical study. Total of 136 patients of solid tumor were dosed (i.e., 102 subjects in study arm and 34 subjects in the reference arm) with initial double-blind period of 24 weeks (primary efficacy) followed by open-label phase till week 36. Primary endpoint was the incidence of first on-study SRE including hypercalcemia of malignancy with co-primary endpoint of median time to first on-study SRE. Secondary endpoints included mean number and time to first and subsequent on-study SREs (week 12, 24, 36), incidence/proportion of patients with first and subsequent on-study SREs (week 24, 36), change from baseline in nuclear bone scan, quality of life assessment, pharmacokinetics, pharmacodynamic, and safety. Results In biosimilar study arm, 06 (5.83%) patients suffered SRE from baseline to week 24 compared with 02 (5.71%) patients in reference arm with one (0.97%) patient showing pathological fracture in study arm and one (2.86%) patient having spinal cord compression in reference arm. There was no statistically significant difference in median time to first SRE, mean number of SRE/patient in both arms and improvement in bone repair on nuclear scan at 12, 24 and 36 weeks. Though the study arm showed better health-related quality of life (HRQoL), mean change in HRQoL was statistically not different in both the arms. Pharmacodynamics, serum bone-specific alkaline phosphatase, pharmacokinetic and safety evaluation did not show any statistical difference between arms. Conclusion There was no clinically meaningful difference in the biosimilar denosumab and reference product after detailed efficacy and safety evaluation.

Ondansetron as Prophylactic against Hypotension and Bradycardia Following Spinal Anaesthesia in Elective Caesarean Section: a Case Control Study

Introduction: Hypotension and bradycardia following the administration of spinal anesthesia for cesarean section are very common and bear profound detrimental effects both on mother and baby. In our country, a significant proportion of patients undergo cesarean section delivery. Considering the workload and the socio-economic condition it is often a bad headache for our anesthesiologists to combat post-spinal hypotension. Vasopressor drugs have been widely used to prevent and treat maternal hypotension during cesarean section under spinal anesthesia. A combination of preloading and using vasopressor has maximum efficacy in preventing spinal-induced hypotension but with compromising with some detrimental adverse effects of vasopressor. Amongst vasopressors, ephedrine is widely used but studies found that a higher bolus dose is often required to prevent hypotension and bradycardia. Aim of the study: To find out the efficacy of ondansetron to prevent haemodynamic derrangement in cesarean section under spinal anaesthesia. Methods: This Prospective Randomized Double-Blind Comparative study was conducted at the Department of Anesthesiology and ICU, Dhaka Medical College Hospital, Dhaka, Bangladesh. The study duration was ten months, from March 2015 to January 2016. A total of 120 participants were randomly included in this study.Each participant was included either into “Group A (n=60)” or “Group B (n=60)” by using fixed number card sampling as mentioned earlier. Group B had been considered as control group in the study, Participants of group A received intravenous ondansetron (0.1 mg/kg body weight) and group B received ephedrine (0.5 mg/kg body weight). Result: The majority of the participants (58.33%) from both groups were from the age group of 26-30 years. Parity distribution revealed that 59.17% (n=71) patients were multigravida while 40.33% (n=49) were primi. In total, 80.33% of the participants had ASA I physical status, and 19.17% had ASA II. All patients .......

A Randomized Double-Blind Comparative Study of Efficacy and Safety Between Low-Dose Etoricoxib and Ibuprofen Coadministered with Low-Dose Paracetamol for Dental Pain

Objective: To study the safety and efficacy of low-dose etoricoxib and low-dose paracetamol versus ibuprofen and low-dose paracetamol treatments in patients who experienced acute pain after tooth extraction. Methods: A total of 80 patients were recruited and randomized to two study groups, i.e., EP and IP. Group EP received etoricoxib 30 mg once a day and add-on paracetamol 325 mg eight-hourly, and Group IP received ibuprofen 400 mg and paracetamol 325 mg eight-hourly for three days. The analgesic efficacy was assessed by a visual analog scale, pain relief score, and global evaluation score. Patients were assessed at 0, 6, 24, 48, and 72 h. Safety was assessed by the patient’s estimation of the severity of adverse drug reactions using a 3-point scale and the type of adverse drug reactions reported by the patients after 72 h. Results: Mean pain intensity reduction, mean pain relief score, and global evaluation score all showed better analgesic efficacy results in Group EP as compared to Group IP but were not significant ( P > 0.05) at 6, 24, 48, and 72 h, respectively. No patient had reported any serious adverse drug reaction in both the groups. Mild to moderate adverse reactions were reported in 20% cases in the IP group and 10% cases in the EP group; however, the incidence of GIT intolerance was seen in 17.5% of the cases in the IP group and none in the EP group. Conclusion: Low-dose etoricoxib with low-dose paracetamol has comparable analgesic efficacy with better safety than therapeutic dose ibuprofen and low-dose paracetamol.

Comparative study of hemodynamic responses during laryngoscopy and endotracheal intubation with dexmedetomidine and esmolol

Background: Many drugs used to reduce the hemodynamic stress response during laryngoscopy and endotracheal intubation. The quest for ideal drugs and their dosage without major side effects is still pursued. Dexmedetomidine, an alpha-2 agonist, is emerging as a promising drug to counteract the catecholamine release. Aims and Objectives: This study is done to compare the effect of lower doses dexmedetomidine and esmolol in control of hemodynamic response and stability in cases undergoing laryngoscopy and endotracheal intubation during general anesthesia.Setting and Design: This was a prospective, randomized double-blinded comparative study. Materials and Methods: After approved by the Institute Ethics Committee, consent obtained from 60 patients (n=60) belonging to ASA I or II. Patients were equally divided into twogroups (D and E). Group D patients (n=30) were infused with intravenous dexmedetomidine at 0.75 mcg/kg diluted in 20 ml with normal saline 10 min before induction. Group E patients (n=30) were infused with intravenous esmolol 0.75 mg/kg diluted in 20 ml of normal saline 2 min before intubation. After administration of drugs, SBP, DBP, MAP, HR, and SpO2 were recorded, immediately after induction, after intubation at 1 min, 3 min, 5 min, and 10 min, respectively. Results: Data wereentered into Microsoft Excel datasheet and wereanalyzed using SPSS 22 version software. In the study, there was a significant decrease in SBP, DBP, MAP, and HR from administration till 10 min after intubation inGroup D compared to Group E. No severe hypotension or bradycardia was seen in any of the patients in either group, took part in our study. Conclusion: This study concludes low dose of dexmedetomidine (0.75mcg/kg) was superior to low dose of esmolol (0.75 mg/kg) in maintaining of hemodynamic stability in response to laryngoscopy and tracheal intubation without any significant adverse effects even though both drugs were comparable in suppressing pressor response.

Randomized double blind comparative study of the efficacy of ondansetron and palonosetron in prevention of postoperative shivering in patients undergoing elective LSCS under spinal anaesthesia

Randomized double blind comparative study of the efficacy of ondansetron and palonosetron in prevention of postoperative shivering in patients undergoing elective LSCS under spinal anaesthesia

Comparison of postoperative analgesia with two different doses of dexmedetomidine as an adjuvant to ropivacaine in adductor canal block for unilateral total knee replacement surgery: A randomized double-blinded study.

Multimodal analgesia is used to treat severe postoperative pain (POP) in total knee replacement (TKR) surgery. Adjuvants are used with local anesthetics to improve the quality and duration of pain relief. Studies comparing different doses of dexmedetomidine in adductor canal block (ACB) are sparse to date. This study compares postoperative analgesia with two different doses of dexmedetomidine as an adjuvant to 0.2% ropivacaine in ACB for unilateral TKR. In this prospective, randomized, double-blinded comparative study, sixty patients were divided into two groups: A and B. Postoperatively perineural catheter was inserted and all patients received 0.2% ropivacaine 20 mL bolus followed by an infusion of 0.2% ropivacaine with dexmedetomidine (0.5 µg/Kg in Group A and 1 µg/Kg in Group B) at 8 mL/h. Postoperative pain, motor blockade, rescue analgesia, hemodynamic parameters, sedation, and adverse effects were recorded. Student t, Chi-square, and Mann-Whitney tests were used. Most patients were elderly females (M:15, F:45). Postoperatively, from 2nd to 24th hour, pain score was less in Group B (P < 0.05). The requirement of rescue analgesic was also less in Group B (A:B 330 µg:60 µg; 23%:6%). Motor blockade assessed using modified Bromage scale and sedation using Richmond agitation sedation scale did not show any statistical difference. Dexmedetomidine infusion at 1 µg/Kg is a better adjuvant to 0.2% ropivacaine than 0.5 µg/Kg in ACB. It provides better analgesia without producing sedation, motor blockade, hemodynamic changes, or any adverse effects.

Effect of single-dose intravenous dexamethasone on postoperative pain and postoperative nausea and vomiting in patients undergoing lower segment cesarean section under spinal anesthesia

Background: Lower segment caesarean sections (LSCS) are commonly done under spinal anaesthesia. Although spinal anaesthetic techniques are relatively safe and associated with quick and uneventful recovery, post-operative pain is a major concern after effect of spinal anaesthesia weans off. Other than pain postoperative nausea and vomiting (PONV) is one of the important side effects of spinal anaesthesia. Steroids by virtue of their anti-inflammatory effect is expected to reduce pain consequent upon inflammation and many studies have shown their efficacy in reducing pain as well as PONV in post-operative patients. Aims and Objectives: Primary objective of the study was to evaluate efficacy of single-dose dexamethasone in reducing post-operative pain. The secondary objectives were to analyse effect of single-dose dexamethasone on hemodynamic stability as well as incidence of nausea and vomiting in patients undergoing LSCS under spinal anesthesia. Materials and Methods: This was a double-blind comparative study in which 60 patients undergoing LSCS under spinal anaesthesia were included on the basis of a predefined inclusion and exclusion criteria. Written informed consent was obtained from all patients. The patients were divided into two groups: Group D: 30 patients who received IV dexamethasone 8 mg (2 ml) intravenously just before giving spinal anesthesia. Group N: 30 patients who received Normal saline (2 ml) immediately before spinal anesthesia. In both groups, hemodynamic parameters, respiratory rate, severity of post-operative pain, and incidence of PONV was compared. P value less than 0.05 was taken as statistically significant. Results: Patients in Group D had significantly less severe post-operative pain (as assessed by the Visual analog scale) and incidence of PONV (P&lt;0.05). Significantly less post-operative rescue analgesia was required in patients who received single dose of intravenous dexamethasone (P&lt;0.05). In terms of hemodynamic stability, both groups were found to be comparable with no statistically significant difference. Conclusion: Single-dose dexamethasone is effective in reducing post-operative pain as well as incidence of PONV in patients undergoing LSCS under spinal anesthesia.

COMPARISON OF ORAL PREMEDICATION BETWEEN MIDAZOLAM AND CLONIDINE FOR GENERALANAESTHESIA IN ELECTIVE OPEN ABDOMINAL SURGERY

Anxiety is common in patients undergoing even minor surgery and it increases as the surgical event approaches. Treating anxiety not only improves patient satisfaction but it also decreases the hospital stay and offers good recovery. It decreases the surgical stress response, incidences of postoperative nausea and vomiting. The most commonly used agents for anxiolysis in Premedication are Benzodiazepines and Alpha 2 agonists. This study is a double blinded comparison of oral Midazolam and Clonidine as anxiolytic and sedative agent for general anaesthesia in elective open abdominal surgery. Laryngoscopy and intubation cause intense sympatho-adrenal stimulation resulting in tachycardia, rise of systolic BP, diastolic BP, Mean Arterial Blood Pressure, decrease in coronary perfusion due to decrease in diastole duration, increase in various cardiac dysrhythmias. In cardiac compromised patients this stress reaction may result in myocardial infarction and heart failure. Also there is a chance of bleeding in brain following rupture of any pre-existing cerebral aneurysm. The multi modal approach of GA encompasses use of anti-anxiety medication, opioids, volatile anaesthetics, local anaesthetics (locally , intravenously, regionally), vasodilators, CCB, Beta 1 adrenoceptor blocker, Alpha 2 adrenoceptor agonists, in combination, with varying degrees of success. METHOD: In this randomized prospective double blinded comparative study 80 patients were randomly divided into 2 groups namely Group M and Group C. Group M received Tablet Midazolam 7.5 mg while Group C received Tablet Clonidine 150 mcg, given orally, preoperatively 90 minutes before induction. Group M showed better sedation after induction, however, Group C showed better hemodynamic stability therefore had better attenuation of sympatho-adrenal response. Conclusion: Considering all parameters, it was observed that Group C was signicantly more efcacious in attenuation of sympatho-adrenal response whereas Group M showed signicantly better sedation.

Dexmedetomidine versus fentanyl on stress response and pain control in adult patients undergoing laparoscopic surgery

Laparoscopic procedures are widely indicated; however, the ideal approach for pain control remains debatable. This trial compared between the effects of dexmedetomidine and fentanyl infusion on stress response and pain control in patients undergoing elective laparoscopic surgeries. A prospective randomized double-blinded comparative study included 82 adult participants randomly allocated into two equal-sized groups. Group D received 1 µg/kg of intravenous (IV) dexmedetomidine over 10 min as a loading dose just before induction of anesthesia, then 0.2–0.7 µg/kg/h till 10 min before the surgery ends. Group F received 1 µg/kg of IV fentanyl as a loading dose, then 0.2–0.7 µg/kg/h. Primary objective was postoperative analgesic consumption in 24 h. Collected data were heart rate (HR), mean arterial blood pressure (MAP), blood glucose and serum cortisol levels, visual analogue score (VAS), and the perioperative analgesic consumption. Group D consumed significantly less postoperative morphine doses in 24 h (p = 0.003), and 41.5% of Group D patients did not need any postoperative morphine. Group D had better-controlled hemodynamic changes 5 min post-extubation (HR and MAP p = 0.021 and p = 0.022 respectively), showed significantly less postoperative stress response as manifested in the blood glucose and serum cortisol levels 4 h postoperatively (p = 0.006 and p = 0.001 respectively), and less VAS pain scores at early and late postoperative periods. Intraoperative IV dexmedetomidine administration as a sole analgesic agent for patients undergoing elective laparoscopic surgeries serves as a convenient anesthetic approach, since it provided a good postoperative pain control, and reduced the surgical stress response and the perioperative analgesic consumption.

Daily intake of Citrus jabara fruit peel powder (Japanese Patent No. 5,323,127) improves allergy-like symptoms: A randomized double-blind parallel-group comparative study

Citrus jabara (CJ) is a rare citrus fruit that used to grow naturally only in the southern part of the Kii Peninsula in Japan. Human intervention studies with oral intake of CJ fruit have shown its anti-allergic effects, but the testing method was a pre-post comparison study. In this study, we conducted a randomized, double-blind, parallel-group interventional study to evaluate the volume-dependent effects of oral intake of CJ fruit peel powder (Japanese Patent No. 5,323,127) on nasal and eye allergy-like symptoms. Ninety healthy adults were allocated to three groups and given test foods containing 1,000, 500, and 0 mg of CJ peel powder, with one packet per day for 4 weeks. After excluding those who dropped out or deviated from the study protocol, 73 were included in the efficacy analysis and 86 in the safety analysis. The high-dose group (1,000 mg/day) was significantly lower than the placebo group in the scores of “nasal and eye symptoms” at week 4, and “blocked nose” at weeks 2 and 4 in the evaluation of question I of Japanese Rhino-conjunctivitis Quality of Life Questionnaire (JRQLQ No. 1). The changes in scores (difference from the pre-observation period) on the Nasal and Eye Symptom Questionnaire showed a dose-dependent reduction in rhinorrhea. In the safety evaluation, there were no significant differences in examinations of physiology, hematology, and blood biochemistry between the groups, and no adverse events attributable to the test foods were observed. These results suggest that intake of CJ peel powder can alleviate allergy-like symptoms.

Combination of carboxytherapy with narrowband‐ultraviolet B in the treatment of recalcitrant areas of vitiligo: A randomized clinical trial

Carboxytherapy has been used in the treatment of autoimmune skin diseases such as psoriasis and morphea. Carboxytherapy has antioxidant effects, and leads to better tissue oxygenation, and release of growth factors. In this article, we decided to evaluate efficacy of combined carboxytherapy and narrowband-ultraviolet B (NB-UVB) compared to NB-UVB alone in the treatment of vitiligo. This is a prospective, split-body double-blind comparative study performed in patients with generalized stable vitiligo in acral areas and extremities referred to dermatology clinic of Afzalipour hospital in Kerman University of Medical Sciences. NB-UVB was performed three times a week in non-consecutive days for 4 months. In each patient, one lesion was randomly treated with carboxytherapy (weekly sessions for total of 16 sessions). Efficacy of treatment was evaluated by percentage of repigmentation of the lesions. Chi-square test and analysis of variance test (ANOVA) were used to compare efficacy of treatment based on demographic features of the patients and clinical features of the lesions, respectively. Twenty-eight patients with mean age of 32.35 ± 7.37 years old completed the study. At the end of the treatment, 37% of the patients in combination therapy group demonstrated more than 75% improvement compared to 0% in the monotherapy group (p=0.001). There was no significant difference between either demographic features of the patients (age, sex, and skin phototypes) or duration of disease with efficacy of the treatment in both groups. Combination of carboxytherapy with NB-UVB leads to higher percentage of repigmentation and patients' satisfaction compared to monotherapy with NB-UVB.

A Comparative Double Blind Study of Nasal Dressing Sponge® versus Merocel® as Nasal Pack after Nasal Surgery.

Introduction:Nasal packing is a common procedure used to ensure haemostasis after nasal surgery.Materials and Methods:A prospective, randomized, controlled and double-blinded study was conducted on 80 consecutive subjects to investigate whether using Nasal Dressing Sponge® (NDS) instead of simple Merocel® might improve patients’ postoperative experience of nasal packing.Results:During the stay of the tampons no differences were noticed between the two groups as regards the postoperative pain. When it comes to pain during the packing removal, patients complained of worse symptoms in the side packed with Merocel. There was no bleeding after the removal of Merocel, whereas 5,6% patients were subject to some bleeding when NDS was removed.Conclusion:Merocel and NDS gave similar results regarding haemostatic activity. Nasal Dressing Sponge could decrease pain during the removal of the nasal pack, while it could be associated to a bigger incidence of mild bleeding after removing the pack.

Nalbuphine versus dexmedetomidine for attenuation of haemodynamic response to laryngoscopy and intubation: A randomised double blind comparative study

Laryngoscopy and intubation are noxious stimuli which result in marked sympathetic response. However, literature search did not reveal any study comparing nalbuphine and dexmedetomidine for attenuation of haemodynamic response to laryngoscopy and intubation.After Institutional Ethical Committee approval and written informed consent, 80 ASA I and II patients were randomised in two groups of 40 each. Group N received 0.2 mg/kg of nalbuphine; group D received 1 µg/kg dexmedetomidine over a period of 10 min. Anaesthesia was induced as per standard general anaesthesia practice. Haemodynamic parameters [Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), &amp; Mean Arterial Pressure (MAP)] were recorded at baseline, 0, 1, 3, 5, 10, and 15 min following intubation. Patients were also observed for any side effects of the study drugs.There was a significant decrease (p&amp;#60;0.001) in mean HR in group D compared to group N, after administration of drug and 1 min after intubation. Both group N and group D showed no significant increase in mean HR at any time point compared to baseline values. There was no significant increase in mean SBP at any time interval in both the groups when compared to baseline. There was a significant increase (p&amp;#60;0.001) in mean DBP and MAP at the time of intubation in group N whereas no significant increase in mean DBP, and MAP was observed in group D at any time point.Dexmedetomidine was found to be more effective in attenuating haemodynamic response to laryngoscopy and intubation as compared to nalbuphine.

USG Guided Supraclavicular, Vertical Infraclavicular and Coracoid Infraclavicular Approach of Brachial Plexus Block: A Double-Blind Comparative Study

USG Guided Supraclavicular, Vertical Infraclavicular and Coracoid Infraclavicular Approach of Brachial Plexus Block: A Double-Blind Comparative Study

A prospective, randomized and double blinded clinical comparative study to evaluate dexmedetomidine and nitro-glycerine for controlled hypotensive anaesthesia elective spine surgeries

Aim: To compare the efficacy of and safety of dexmeditomidine versus nitroglycerine during hypotensive anaesthesia induced by either drug in adult patients posted for elective spine surgeries. Material and Methods: This was a prospective, randomized, and double blinded clinical comparative study conducted in the Department of Anaesthesiology, ESIC Medical College, Sanath Nagar, Hyderabad, Telangana, India for the period of 1 year. 100 participants belonging to ASA class I or II between 20 and 55 years of age scheduled for elective spine surgeries were include in this study. The study drug dexmeditomidine was given to group DX in the dose of 1 micro gram/kg body weight in a 600 seconds infusion before induction diluted to 10 ml with normal saline followed by maintenance dose at infusion rate of 0.2- 0.7 microgm/kg. The group NG received 10 ml plain normal saline over 600 seconds before induction followed by maintenance dose of nitroglycerine at an infusion rate of 0.5-10 microgm/kg/min. different parameter were compared in both the groups.

Clinical significance of the water retention and barrier function‐improving capabilities of ceramide‐containing formulations: A qualitative review

A decrease in the ceramide content of the stratum corneum is known to cause dry and barrier‐disrupted skin. In this literature review, the clinical usefulness of preparations containing natural or synthetic ceramides for water retention and barrier functions was evaluated. The PubMed, Cochrane Library, and Igaku Chuo Zasshi databases were searched using keywords such as “ceramide”, “skincare products”, “barrier + hydration + moisture + skin”, and “randomized trial”. All database searches were conducted in February 2019. Forty‐one reports were selected based on the following criterion: comparative control studies that evaluated the effects of ceramide‐containing formulations based on statistical evidence. Among the 41 reports, 12 were selected using the patient, intervention, comparison, and outcome approach. These 12 reports showed that external ceramide‐containing preparations can improve dry skin and barrier function in patients with atopic dermatitis. However, a double‐blinded comparative study with a large sample size is warranted for appropriate clinical use.

COMPARISON BETWEEN PERINEURAL DEXAMETHASONE AND INTRAVENOUS MAGNESIUM SULPHATE AS ADJUVANT IN SUPRACLAVICULAR BLOCK

Abstract Background: Upper extremity surgeries are commonly performed under regional anaesthesia. Regional anaesthesia of the upper extremity has several advantages over general anaesthesia such as improved postoperative pain management, decreased postoperative narcotic consumption, and reduced recovery time. Objectives: The aim of the study was to compare between dexamethasone and magnesium sulphate as adjuvants in supraclavicular brachial plexus block as regards the onset and duration of sensory and motor block as well as side effects. Patients and Methods: This prospective double-blinded comparative study was carried out in Faculty of Medicine, Ain-Shams University Hospital on 120 adult patients between 21-50 years of both sexes with ASA classification 1&amp;2 who were scheduled for elective upper limb orthopaedic surgeries. A written informed consent was obtained from all patients. Every patient received an explanation about the purpose of the study. Procedures had been approved by the institutional and the regional ethical committee. Total 120 patients are enrolled in the study and divided into 3 groups A and B and C (40 for each one). Results From aspect of increasing the duration of sensory &amp;motor block magnesium sulphate group (group A) showed higher prolongation of sensory &amp; motor block with recovery of pin prick sensation in median time 313 mins ± when compared with group B &amp;C even with longer time taken for patient to request rescue analgesia after 5 hours. In group (B) by adding dexamethasone with bupivacaine the blood pressure rate are increased after 20 min of injection and return normal after 240 min, heart rate are normal, but in case of sensory and motor block about 77.5% of study patient in this group have full motor and sensory block, in case of increasing time of motor and sensory block the dexamethasone success increasing time for motor and sensory block to reach 278 min sensory and 314 min in motor block, first call of Analgesic are after 4 hr. Conclusion: Group A (Magnesium sulphate with bupivacaine) were more effective and increasing affected time in motor and sensory block than Group B (Dexamethasone with Bupivacaine) and Group C (Control).

A multicenter, randomized, double-blind, placebo-controlled, comparative study to evaluate the efficacy and safety of newly developed diclofenac patches in patients with cancer pain.

This phase III multicenter randomized double-blind placebo-controlled comparative study evaluated the efficacy and safety of diclofenac sodium patches for the treatment of cancer pain. The study consisted of a 2-week to 4-week open-label dose-titration phase and a 4-week double-blind phase. In the double-blind phase, patients who were expected to continue treatment of cancer pain with nonopioid analgesics alone were randomized to the diclofenac sodium patch or placebo group. Once-daily diclofenac sodium patches were started at 150 mg/day (2 patches) and could be increased up to 225 mg/day (3 patches). The primary efficacy endpoint was the time to insufficient analgesic response. Statistical analysis of the double-blind phase included data from 120 patients of the diclofenac sodium patch group and 118 patients of the placebo group. Time to insufficient analgesic response was significantly longer with diclofenac sodium patches than with placebo (P = 0.0016). The hazard ratio for insufficient response for diclofenac sodium patch vs placebo was 0.459 (95% confidence interval, 0.275-0.768). Regarding sleep quality during the double-blind phase, the proportion of patients with "very good sleep" or "good sleep" in the diclofenac sodium patch and placebo groups was 90.8% and 88.1% at the start of the double-blind phase and 81.4% and 78.6% at the final assessment, respectively. The incidence of adverse events was 60.8% (73/120) in the diclofenac sodium patch group and 60.2% (71/118) in the placebo group. Once-daily diclofenac sodium patches are effective in treating cancer pain and are well tolerated.

Long-term efficacy, safety, and immunogenicity of the adalimumab biosimilar, PF-06410293, in patients with rheumatoid arthritis after switching from reference adalimumab (Humira\xae) or continuing biosimilar therapy: week 52\u201392 data from a randomized, double-blind, phase 3 trial

Background/objectiveREFLECTIONS B538–02 is a randomized, double-blind comparative study of the adalimumab (ADL) biosimilar PF-06410293, (ADL-PF), and reference ADL sourced from the European Union (ADL-EU) in patients with active RA. Therapeutic equivalence was demonstrated based on ACR20 responses at week 12 (primary endpoint). We report long-term safety, immunogenicity, and efficacy of ADL-PF in patients who continued ADL-PF treatment throughout 78 weeks or who switched from ADL-EU to ADL-PF at week 26 or week 52.MethodsEligible patients (2010 ACR/EULAR RA diagnosis criteria for ≥ 4 months; inadequate response to MTX, ≤ 2 doses non-ADL biologic), stratified by geographic regions were initially randomized (1:1) in treatment period 1 (TP1) to ADL-PF or ADL-EU (40 mg subcutaneously, biweekly), both with MTX (10–25 mg/week). At week 26 (start of TP2), patients receiving ADL-EU were re-randomized to remain on ADL-EU or transition to ADL-PF for 26 weeks. At week 52 (start of TP3), all patients received open-label treatment with ADL-PF for 26 weeks and were followed after last treatment dose to week 92. To evaluate maintenance of response after switching or remaining on ADL-PF, ACR20, DAS28-4(CRP), and other measures of clinical response/remission were assessed through week 78 as secondary endpoints. Three groups were evaluated: biosimilar, week 26 switch, and week 52 switch.ResultsOverall, 507 patients participated in TP3. ACR20 response rates at week 52 were 88.4%, 88.2%, and 87.6% for the biosimilar, week 26, and week 52 switch groups, respectively. ACR20 response rates and DAS28-4(CRP) scores were sustained and comparable across groups in TP3. Incidence of treatment-emergent adverse events (AEs) during TP3 and follow-up was 42.6% (biosimilar), 37.0% (week 26 switch), and 50.8% (week 52 switch); 3 (0.6%) patients (all week 52 switch) reported treatment-related serious AEs. ADL-PF was generally well tolerated, with a comparable safety profile across groups. Overall, incidences of patients with anti-drug antibodies in TP3 and follow-up were comparable among groups (46.1%, 46.5%, and 54.2%, respectively).ConclusionsThere were no clinically meaningful differences in safety, immunogenicity, and efficacy for patients who were maintained on ADL-PF for 78 weeks and those who had switched from ADL-EU at week 26 or week 52.Trial registrationClinicalTrials.gov, NCT02480153. First posted on June 24, 2015; EU Clinical Trials Register; EudraCT number: 2014-000352-29. Start date, October 27, 2014