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NOT YET RECRUITING
NCT07896798
PHASE4

Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb

Sponsor: Aga Khan University

View on ClinicalTrials.gov

Summary

The goal of this randomized controlled clinical trial is to evaluate the effectiveness of postoperative bupivacaine infusion through a perineural catheter in managing postoperative pain and to determine the opioid consumption among patients undergoing major lower-limb amputation surgery. The main questions it aims to answer are: * Does postoperative bupivacaine infusion through a perineural catheter provide better postoperative pain control as compared to intravenous opioid analgesia alone? * Does postoperative bupivacaine infusion through a perineural catheter reduce intravenous opioid consumption within the first 48 hours after surgery compared with intravenous opioid analgesia alone? * Does the postoperative Bupivacaine infusion through perineural catheter help in reducing the phantom pain at 6 months follow-up?

Official title: Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb: A Randomized Controlled Trial.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2026-12-01

Completion Date

2028-07

Last Updated

2026-11-02

Healthy Volunteers

No

Interventions

DRUG

Bubpivacaine

Bupivacaine (0.125%) infusion will be stated Postoperatively

DRUG

Tramadol

The opioid infusion will consist of the standard of care for pain control (Tramadol 10mg/ml ) after major amputation. Infusion rate and dosage will be determined as per the requirement for the individual patient and patient who will not respond to Tramadol infusion will receive Morphine 2mg IV stat as a rescue analgesia.

DRUG

Saline

Saline will be started through the peri-neural catheter postoperatively