Sciatic Perineural Versus Stump Catheter for Below Knee Amputation

NCT ID: NCT01608035

Last Updated: 2016-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-07-31

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.

Conditions

Ischemia; Phantom Limb Pain; Vascular Disease; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

sciatic catheter

Group Type: EXPERIMENTAL

Sciatic catheter

Intervention Type: PROCEDURE

presurgical sciatic catheter insertion

Stump catheter

Group Type: ACTIVE_COMPARATOR

Stump catheter

Intervention Type: PROCEDURE

intraoperative placed stump catheter

Interventions

Sciatic catheter

presurgical sciatic catheter insertion

Intervention Type: PROCEDURE

Stump catheter

intraoperative placed stump catheter

Intervention Type: PROCEDURE

Other Intervention Names

anesthesiologist placed catheter; surgeon placed catheter

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew N Sawka, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Jason Wilson

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H12-00693

Identifier Type: -

Identifier Source: org_study_id