drugset / Trial / NCT07294352

Comparison of Intrathecal Nalbuphine Versus Intrathecal Tramadol as Adjuvants in Subarachnoid Block for Lower Limb Orthopaedic Surgeries

NCT07294352

Active not recruiting 40 enrolled CMH Lahore Medical College and Institute of Dentistry
RandomizedParallel-groupTriple-blindTreatment

Summary

This study compares the use of intrathecal nalbuphine versus intrathecal tramadol as adjuvant agents to local anaesthetics in subarachnoid block for lower-limb orthopaedic surgeries. The primary objective is to determine whether there is a meaningful difference between the two drugs in terms of quality and duration of intraoperative and postoperative analgesia. Secondary outcomes include onset and efficacy of sensory and motor block, time to first rescue analgesia, incidence of adverse effects, and perioperative hemodynamic stability. By evaluating these parameters, the study aims to identify which adjuvant provides superior analgesic benefits with fewer side effects in patients undergoing lower-limb orthopedic procedures.

Timeline

Start
2026-01-01
Primary completion
2026-07-01
Completion
2026-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Nalbuphine Small molecule 1 mg Intrathecal
Comparator Tramadol Other / unclassified 20 mg Intrathecal
Background Bupivacaine Other / unclassified 0.5 %

Indications

No indication recorded.