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

NCT07294352 | Active Not Recruiting

• 1 other identifier: 566/2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adjuvants, Anesthesia; Subarachnoid Block

Keywords

Subarachnoid block; Adjuvants

Outcome Measures

Primary Outcomes (1)

• Duration of spinal anesthesia

  Time until first rescue analgesia at VAS \<4. (Visual Analog scale measures subjective pain intensity on a continuous scale. Score 0 means no pain while 10 means most pain possible)

  up to 24 hours post operatively

Study Arms (2)

Tramadol group

ACTIVE COMPARATOR

Intrathecal tramadol 20mg + bupivacaine 0.5%

Drug: Intrathecal tramadol with spinal anesthsia

Intrathecal nalbuphine

EXPERIMENTAL

Intrathecal nalbuphine 1 mg + bupivacaine 0.5%

Drug: Intrathecal nalbuphine and spinal anesthesia

Interventions

Intrathecal tramadol with spinal anesthsia DRUG

intrathecal tramadol 20mg with Hyperbaric 0.5% bupivacaine

Tramadol group

Intrathecal nalbuphine and spinal anesthesia DRUG

intrathecal nalbuphine 1mg with 0.5% Hyperbaric Bupivacaine

Intrathecal nalbuphine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA Physical Status 1 and 2 Undergoing surgical correction of lower limb fracture

You may not qualify if:

• hypersensitivity to opioids or local anesthetics patient refusal

Sponsors & Collaborators

• CMH Lahore Medical College and Institute of Dentistry: lead

Study Sites (1)

Combined Military Hospital Lahore

Lahore, Pakistan

Location

Related Publications (1)

• Sharma A, Chaudhary S, Kumar M, Kapoor R. Comparison of nalbuphine versus fentanyl as intrathecal adjuvant to bupivacaine for orthopedic surgeries: A randomized controlled double-blind trial. J Anaesthesiol Clin Pharmacol. 2021 Oct-Dec;37(4):529-536. doi: 10.4103/joacp.JOACP_270_18. Epub 2022 Jan 6.

  PMID: 35340949 BACKGROUND

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Khadija Zubair

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

PA (1)