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Sciatic Perineural Versus Stump Catheter for Below Knee Amputation

This study has been completed.
Information provided by (Responsible Party):
University of British Columbia Identifier:
First received: May 11, 2012
Last updated: May 18, 2016
Last verified: May 2016

May 11, 2012
May 18, 2016
September 2012
July 2015   (final data collection date for primary outcome measure)
Opioid consumption [ Time Frame: Post-op day 0-7 ] [ Designated as safety issue: No ]
MAR records will be used to calculate opioid consumption
Same as current
Complete list of historical versions of study NCT01608035 on Archive Site
pain score [ Time Frame: Post-op day 0-7 and at 3months ] [ Designated as safety issue: No ]
VAS will be used (0-10)
Same as current
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Sciatic Perineural Versus Stump Catheter for Below Knee Amputation
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
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.
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ischemia
  • Phantom Limb Pain
  • Vascular Disease
  • Chronic Pain
  • Procedure: Sciatic catheter
    presurgical sciatic catheter insertion
    Other Name: anesthesiologist placed catheter
  • Procedure: Stump catheter
    intraoperative placed stump catheter
    Other Name: surgeon placed catheter
  • Experimental: sciatic catheter
    Intervention: Procedure: Sciatic catheter
  • Active Comparator: Stump catheter
    Intervention: Procedure: Stump catheter
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2015
July 2015   (final data collection date for primary outcome measure)

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
16 Years to 90 Years   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: Andrew N Sawka, MD, FRCPC University of British Columbia
University of British Columbia
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP