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

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07896798

Enrollment

Registered

2026-10-27

Start date

2026-12-01

Completion date

2028-07-01

Last updated

2026-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Limb Surgery, Pain, Phantom Limb Pain After Amputation, Stump Pain, Amputation

Brief 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?

Interventions

DRUGBupivacaine Infusion

Bupivacaine (0.125%) infusion will be stated Postoperatively

DRUGOpioid Infusion

The opioid infusion will consist of the standard of care for pain control (Tramadol 10mg/ml, morphine 2mg IV ) after major amputation. Infusion rate and dosage will be determined as per the requirement for the individual patient.

DRUGSaline

Saline will be started through the peri-neural catheter postoperatively

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Patients aged 18 and above * Patients undergoing lower limb amputation. * ASA status I to IV. * Patients under general or spinal anaesthesia

Exclusion criteria

* Patients with no allergies to study drugs (inje Bupivacaine 0.125%, Inje Tramadol, Inje Morphine) * Pregnant and lactating patients * Patients who require post-operative ventilatory support in ICU * Those with open wound of amputation stump * Procedures performed under peripheral nerve block

Design outcomes

Primary

Measure	Time frame	Description
Postoperative Pain	First pain assessment will be done after half hour of PACU stay. Subsequently pain will be assessed at six hours, 12 hours, 24 hours and 48 hours postoperatively.	Postoperative pain will be measured at different timepoints through numerical rating scale (NRS). NRS is 10 points scale , where '0' represents 'no pain' and '10' represents the worst pain imaginable.
Opioid consumption	Opioid consumption will be assessed 48 hours postoperatively	—

Secondary

Measure	Time frame
Incidence of phantom limb pain	At 6 months Postoperatively

Contacts

CONTACTFareed Shaikh, MBBS, MRCSEd, FCPS(Vascular)

fareed.shaikh@aku.edu+923218110155

CONTACTMohsin N Butt, MBBS, FCPS (Anesthesiology)

+923212227083

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 28, 2026