NCT07294352

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: CMH Lahore Medical College and Institute of Dentistry · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

The effectiveness of Intrathecal Nalbuphine 1mg versus Intrathecal Tramadol 20mg as adjuvant to 0.5% hyperbaric bupivacaine in Subarachnoid block for orthopaedic surgeries of the lower limbs is studied. Primary outcomes of the study are onset of sensory block, onset of motor block, intraoperative hemodynamic stability and postoperative analgesia measured on visual analog scale. Secondary outcomes were incidence of side-effects and the need for rescue analgesia.

Conditions

• Adjuvants, Anesthesia
• Subarachnoid Block

Interventions

Type	Name	Description
DRUG	Intrathecal tramadol with spinal anesthsia	intrathecal tramadol 20mg with Hyperbaric 0.5% bupivacaine
DRUG	Intrathecal nalbuphine and spinal anesthesia	intrathecal nalbuphine 1mg with 0.5% Hyperbaric Bupivacaine

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-07-01
• Completion: 2026-08-01
• First posted: 2025-12-19
• Last updated: 2026-03-18

Locations

1 site across 1 country: Pakistan