Sciatic Perineural Versus Stump Catheter for Below Knee Amputation

Chronic Pain Clinical Trial

Official title:

Ultrasound Guided Sciatic Perineural Catheter vs Surgically Placed Sciatic Stump Catheter for Below Knee Amputations: Is There A Difference in Patient Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01608035
• Other study ID #: H12-00693
• Status: Completed
• Phase: Phase 0
• First received: May 11, 2012
• Last updated: May 18, 2016
• Start date: September 2012
• Est. completion date: July 2015

Study information

• Verified date: May 2016
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Ischemia
• Phantom Limb
• Phantom Limb Pain
• Vascular Disease
• Vascular Diseases

Intervention

Procedure:
• Sciatic catheter
presurgical sciatic catheter insertion
• Stump catheter
intraoperative placed stump catheter

Locations

Country	Name	City	State
Canada	Jason Wilson	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	MAR records will be used to calculate opioid consumption	Post-op day 0-7	No
Secondary	pain score	VAS will be used (0-10)	Post-op day 0-7 and at 3months	No