Sciatic Perineural Versus Stump Catheter for Below Knee Amputation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01608035
Recruitment Status : Completed
First Posted : May 30, 2012
Last Update Posted : May 20, 2016
Information provided by (Responsible Party):
University of British Columbia

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

Condition or disease Intervention/treatment Phase
Ischemia Phantom Limb Pain Vascular Disease Chronic Pain Procedure: Sciatic catheter Procedure: Stump catheter Early Phase 1

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  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2012
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Opioid consumption [ Time Frame: Post-op day 0-7 ]
    MAR records will be used to calculate opioid consumption

Secondary Outcome Measures :
  1. pain score [ Time Frame: Post-op day 0-7 and at 3months ]
    VAS will be used (0-10)

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01608035

Canada, British Columbia
Jason Wilson
Vancouver, British Columbia, Canada, V5Z 1L8
Sponsors and Collaborators
University of British Columbia
Principal Investigator: Andrew N Sawka, MD, FRCPC University of British Columbia

Responsible Party: University of British Columbia Identifier: NCT01608035     History of Changes
Other Study ID Numbers: H12-00693
First Posted: May 30, 2012    Key Record Dates
Last Update Posted: May 20, 2016
Last Verified: May 2016

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

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