Sciatic Perineural Versus Stump Catheter for Below Knee Amputation

May 18, 2016 updated by: University of British Columbia

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

29

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1L8
        • Jason Wilson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 90 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: sciatic catheter
Procedure: Sciatic catheter
presurgical sciatic catheter insertion
Other Names:
  • anesthesiologist placed catheter
ACTIVE_COMPARATOR: Stump catheter
Procedure: Stump catheter
intraoperative placed stump catheter
Other Names:
  • surgeon placed catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: Post-op day 0-7
MAR records will be used to calculate opioid consumption
Post-op day 0-7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score
Time Frame: Post-op day 0-7 and at 3months
VAS will be used (0-10)
Post-op day 0-7 and at 3months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Andrew N Sawka, MD, FRCPC, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

May 11, 2012

First Submitted That Met QC Criteria

May 29, 2012

First Posted (ESTIMATE)

May 30, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 20, 2016

Last Update Submitted That Met QC Criteria

May 18, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H12-00693

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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