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Sciatic Perineural Versus Stump Catheter for Below Knee Amputation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01608035
First Posted: May 30, 2012
Last Update Posted: May 20, 2016
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.
Information provided by (Responsible Party):
University of British Columbia
May 11, 2012
May 30, 2012
May 20, 2016
September 2012
July 2015   (Final data collection date for primary outcome measure)
Opioid consumption [ Time Frame: Post-op day 0-7 ]
MAR records will be used to calculate opioid consumption
Same as current
Complete list of historical versions of study NCT01608035 on ClinicalTrials.gov Archive Site
pain score [ Time Frame: Post-op day 0-7 and at 3months ]
VAS will be used (0-10)
Same as current
Not Provided
Not Provided
 
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.
Interventional
Early Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
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
Sexes Eligible for Study: All
16 Years to 90 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01608035
H12-00693
Yes
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