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Sciatic Perineural Versus Stump Catheter for Below Knee Amputation

Primary Purpose

Ischemia, Phantom Limb Pain, Vascular Disease

Status
Completed
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Sciatic catheter
Stump catheter
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemia focused on measuring sciatic catheter, stump catheter, below knee amputation

Eligibility Criteria

16 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jason Wilson

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

sciatic catheter

Stump catheter

Arm Description

Outcomes

Primary Outcome Measures

Opioid consumption
MAR records will be used to calculate opioid consumption

Secondary Outcome Measures

pain score
VAS will be used (0-10)

Full Information

First Posted
May 11, 2012
Last Updated
May 18, 2016
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT01608035
Brief Title
Sciatic Perineural Versus Stump Catheter for Below Knee Amputation
Official Title
Ultrasound Guided Sciatic Perineural Catheter vs Surgically Placed Sciatic Stump Catheter for Below Knee Amputations: Is There A Difference in Patient Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia, Phantom Limb Pain, Vascular Disease, Chronic Pain
Keywords
sciatic catheter, stump catheter, below knee amputation

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sciatic catheter
Arm Type
Experimental
Arm Title
Stump catheter
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Sciatic catheter
Other Intervention Name(s)
anesthesiologist placed catheter
Intervention Description
presurgical sciatic catheter insertion
Intervention Type
Procedure
Intervention Name(s)
Stump catheter
Other Intervention Name(s)
surgeon placed catheter
Intervention Description
intraoperative placed stump catheter
Primary Outcome Measure Information:
Title
Opioid consumption
Description
MAR records will be used to calculate opioid consumption
Time Frame
Post-op day 0-7
Secondary Outcome Measure Information:
Title
pain score
Description
VAS will be used (0-10)
Time Frame
Post-op day 0-7 and at 3months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew N Sawka, MD, FRCPC
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jason Wilson
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L8
Country
Canada

12. IPD Sharing Statement

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Sciatic Perineural Versus Stump Catheter for Below Knee Amputation

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