Sciatic Perineural Versus Stump Catheter for Below Knee Amputation

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 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: March 5, 2014
Last verified: March 2014
  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:


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: September 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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: March 5, 2014
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on August 20, 2014