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Sciatic Perineural Versus Stump Catheter for Below Knee Amputation

This study is not yet open for participant recruitment.
Verified May 2012 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01608035
First received: May 11, 2012
Last updated: May 29, 2012
Last verified: May 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Ischemia
Phantom Limb Pain
Vascular Disease
Chronic Pain
 Procedure: Sciatic catheter
Procedure: Stump catheter
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ultrasound Guided Sciatic Perineural Catheter vs Surgically Placed Sciatic Stump Catheter for Below Knee Amputations: Is There A Difference in Patient Outcomes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Opioid consumption [ Time Frame: Post-op day 0-7 ] [ Designated as safety issue: No ]
    MAR records will be used to calculate opioid consumption


Secondary Outcome Measures:
  • pain score [ Time Frame: Post-op day 0-7 and at 3months ] [ Designated as safety issue: No ]
    VAS will be used (0-10)


Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sciatic catheter Procedure: Sciatic catheter
presurgical sciatic catheter insertion
Other Name: anesthesiologist placed catheter
Active Comparator: Stump catheter Procedure: Stump catheter
intraoperative placed stump catheter
Other Name: surgeon placed catheter

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.

  Eligibility

Ages Eligible for Study:   16 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608035

Contacts
Contact: Andrew N Sawka, MD 604-875-4304 andrew.sawka@vch.ca

Locations
Canada, British Columbia
Jason Wilson Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1L8
Contact: Andrew N Sawka, MD     604-875-4304     andrew.sawka@vch.ca    
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Andrew N Sawka, MD, FRCPC University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01608035     History of Changes
Other Study ID Numbers: H12-00693
Study First Received: May 11, 2012
Last Updated: May 29, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
sciatic catheter
stump catheter
below knee amputation

Additional relevant MeSH terms:
Ischemia
Phantom Limb
Vascular Diseases
Pathologic Processes
Perceptual Disorders
 Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013