Abstract
BackgroundPostoperative pain is a major complaint following abdominal surgery for gynecological diseases. Effective postoperative pain control after abdominal surgery is particularly important for patient recovery, mobility, and satisfaction. Acupuncture has been commonly used for pain management. However, its efficacy in postoperative pain control is inconclusive and health economic evaluation is limited.MethodsA randomized, sham-controlled, patient- and- assessor-blind trial is designed to evaluate the efficacy and safety of acupuncture in managing postoperative pain following abdominal surgery of gynecological diseases. Patients who are eligible for laparotomy with a midline incision for gynecological neoplasia, including ovarian mass, uterine mass, and cervical lesions, will be recruited. Seventy-two participants will be randomly allocated to an acupuncture or non-invasive sham control in a 1:1 ratio. Treatment will be done within 2 h before operation, upon arrival to the ward and once daily for 5 days. The Pain Numerical Rating Scale (NRS) on the first 5 days during hospitalization will be the primary outcome and will be analyzed using the area-under-the-curve (AUC) method. The secondary outcome measures include frequency of rescue analgesic use during hospital stay, cumulative morphine consumption; quality of recovery as measured by time to recovery variables and the Quality of Recovery-9 (QoR-9); quality of life as measured by the Short Form-6 dimension (SF-6D) and EuroQol-5 Dimension-5 Level (EQ-5D-5 L). The incremental cost-effectiveness ratio of acupuncture vs sham acupuncture will be calculated.DiscussionThis study protocol provides an example of integrative medicine practice in a hospital setting for the management of postoperative pain using acupuncture treatment. The acupuncture treatment protocol, if proven to be effective, can be implemented in routine settings to play a role in postoperative pain management for patients who have undergone abdominal surgery for gynecological diseases.Trial registrationClinicalTrials.gov, ID: NCT02851186. Registered on 19 July 2016.
Highlights
Postoperative pain is a major complaint following abdominal surgery for gynecological diseases
The overall objective of this study is to examine the safety and efficacy of a combined acupuncture treatment of electroacupuncture (EA) and intradermal auricular acupuncture (AA) as an adjunct treatment in reducing postoperative pain in patients after abdominal surgery for gynecological diseases, compared with sham EA in combination with sham AA
The study protocol of the proposed trial will be conducted at the Queen Merry Hospital which is under the Hong Kong Hospital Authority (HA)
Summary
Postoperative pain is a major complaint following abdominal surgery for gynecological diseases. Effective postoperative pain control after abdominal surgery is important for patient recovery, mobility, and satisfaction. If the acute pain is inadequately treated, it may become chronic; surgery contributes to chronic pain in 23% of patients in outpatient pain clinics [1]. Pharmacological agents, such as epidural anesthesia, intraspinal anesthesia, intrapleural anesthesia, or patientcontrolled analgesia (PCA), are effective in relieving postoperative pain in most patients. A safe and effective treatment for postoperative pain is needed
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