Effect of continuous injection of pain relief medication around nerves after amputations of the leg

Not yet recruiting

• Conditions: Local infection of the skin and subcutaneous tissue, unspecified, (2) ICD-10 Condition: I739||Peripheral vascular disease, unspecified,

• Registration Number: CTRI/2023/07/055331
• Lead Sponsor: JIPMER Intramural fund

Brief Summary

This is a clinical, prospective, randomised, open label, controlled trial in which the primary objective is to determine the decrease in patient’s post-operative opioid requirement in those undergoing major lower limb amputation and receiving continuous perineural infusion of bupivacaine for three days compared to those receiving standard care. Secondary objectives are to determine and compare the postoperative continuous perineural infusion of Bupivacaine and standard management after major lower limb amputation for postoperative mean pain score assessed using the visual analog scale (VAS) for three days in both groups, incidence of catheter-related complications (brocade, slippage, wound infections), and incidence of Phantom limb pain.

A sample size of 124 is aimed for and recruited patients undergoing major lower limb amputations will be randomised into the control and study groups intra op after identification of the nerve around which perineural catheter is to be placed. Patients in the control group will recieve bupivacaine infusion for 72h post op via the perineural catheter and post op opioid requirements will be assessed for 72h post op. Secondary outcomes will also be assessed. Patients in the control group will be managed according to standard amputation techniques and anaesthesia protocols.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-07-07
• Study Start: 2023-07-18

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

Adult patients (Age ≥ 18 years) undergoing elective or emergency major lower limb amputations.

Exclusion Criteria

• 1.Patients undergoing hip disarticulation, and hindquarter amputation.
• 2.Patients who have an allergy to bupivacaine 3.Patients are expected to be requiring sedation or ventilatory support for more than 24 hours.
• 4.Patients undergoing revision amputation who have been previously recruited into the study.
• 5.Patients undergoing bilateral amputations.
• 6.Patients in whom the appropriate nerve could not be identified.
• 8.Patient denying consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the decrease in patient’s post-operative opioid requirement in those undergoing major lower limb amputation and receiving continuous perineural infusion of bupivacaine for three days compared to those receiving standard care	Measured every 6h for 72h

Secondary Outcome Measures

Name	Time	Method
To determine and compare the postoperative continuous perineural infusion of Bupivacaine and standard management after major lower limb amputation for postoperative mean pain score assessed using the visual analog scale (VAS) for three days in both groups.
To determine and compare the postoperative continuous perineural infusion of Bupivacaine and standard management after major lower limb amputation for incidence of catheter-related complications (brocade, slippage, wound infections).
To determine and compare the postoperative continuous perineural infusion of Bupivacaine and standard management after major lower limb amputation for incidence of Phantom limb pain	3 months post op

Trial Locations

Locations (1)

JIPMER hospital; 🇮🇳 Pondicherry, PONDICHERRY, India

JIPMER hospital

🇮🇳Pondicherry, PONDICHERRY, India

Julia Sunil

Principal investigator

6374067368

juliasunil96@gmail.com