Randomised control trial comparing postoperative analgesia between nalbuphine and fentanyl as an adjuvant with intrathecal levobupivacaine for lower abdominal gynaecological surgeries

Abstract

Background Effective post-operative pain management is crucial for patient comfort and recovery following lower abdominal gynaecological surgeries. This study protocol outlines a randomised control trial designed to compare the efficacy and safety of two intrathecal adjuvants, nalbuphine and fentanyl, in conjunction with hyperbaric levobupivacaine for postoperative analgesia. Methods The study will be conducted at the Department of Anaesthesiology, Jawaharlal Nehru Medical College, DMIMS (DU), and affiliated institutions. Sixty eligible patients aged 35-75 years undergoing lower abdominal gynaecological surgeries under subarachnoid block will be randomly assigned to one of two groups. Group A will receive nalbuphine with levobupivacaine, while Group B will receive fentanyl with levobupivacaine. Patients will be monitored for the duration of post-operative analgesia, onset of sensory and motor block, hemodynamic effects, and side effects. Outcomes The primary outcome is the comparison of post-operative analgesia duration between nalbuphine and fentanyl. Secondary outcomes include assessing sensory and motor block onset, hemodynamic changes, ephedrine usage, and side effects. Aim To evaluate the efficacy and safety of intrathecal nalbuphine and fentanyl as adjuvants with hyperbaric levobupivacaine for postoperative analgesia in lower abdominal gynaecological surgeries.