Sciatic Perineural Versus Stump Catheter for Below Knee Amputation

Early Phase 1

Completed

• Conditions: Ischemia; Phantom Limb Pain; Vascular Disease; Chronic Pain
• Interventions: Procedure: Sciatic catheter; Procedure: Stump catheter

• Registration Number: NCT01608035
• Lead Sponsor: University of British Columbia

Brief Summary

The goal of this study is to determine if pre-operative placement of the continuous peripheral nerve block by an anesthesiologist using ultrasound technology is more effective than a continuous peripheral nerve block placed during the surgery by a surgeon for patients undergoing a limb amputation

Detailed Description

We wish to determine the most effective site for the continuous infusion of local anesthetic for patients undergoing amputation of a limb. The information we obtain from this study will help to decide the most effective manner to provide pain relief for patients in the future. The primary outcome of interest is post-operative pain relief as measured by the amount of pain-relieving medications (opioids) required by patients prior to discharge home. The secondary outcomes of interest will be pain-relieving medications (opioid) requirements during the operation, length of stay in the hospital, time required for mobility, and patient satisfaction- measured by a survey given while in hospital and 3 months later.

Study Timeline

• Study First Submitted: 2012-05-11
• Study First Submitted QC: 2012-05-29
• Study First Posted: 2012-05-30
• Study Start: 2012-09
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-18
• Last Update Posted: 2016-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• undergoing a below knee amputation
• 16 years of age or older
• regional anesthetic will be used as part of the surgery

Exclusion Criteria

• pregnant
• allergic to local anesthetic or ultrasound jelly
• a contraindication to having a peripheral nerve block catheter

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sciatic catheter	Sciatic catheter	-
Stump catheter	Stump catheter	-

Primary Outcome Measures

Name	Time	Method
Opioid consumption	Post-op day 0-7	MAR records will be used to calculate opioid consumption

Secondary Outcome Measures

Name	Time	Method
pain score	Post-op day 0-7 and at 3months	VAS will be used (0-10)

Trial Locations

Locations (1)

Jason Wilson; 🇨🇦 Vancouver, British Columbia, Canada