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Completed

NCT Number: NCT01608035

Sciatic Perineural Versus Stump Catheter for Below Knee Amputation

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

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Key information

Conditions

Ischemia Cardiovascular Diseases Chronic Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Phantom Limb Phantom Limb Pain Postoperative Complications Signs and Symptoms Vascular Disease Vascular Diseases

Age range

16 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Jason Wilson

Vancouver, British Columbia, V5Z 1L8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sciatic catheter

Procedure

presurgical sciatic catheter insertion

Other names: anesthesiologist placed catheter

Stump catheter

Procedure

intraoperative placed stump catheter

Other names: surgeon placed catheter

Primary outcomes

  1. Opioid consumption

    Time frame: Post-op day 0-7

    MAR records will be used to calculate opioid consumption

Secondary outcomes

  1. pain score

    Time frame: Post-op day 0-7 and at 3months

    VAS will be used (0-10)

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

Ultrasound Guided Sciatic Perineural Catheter vs Surgically Placed Sciatic Stump Catheter for Below Knee Amputations: Is There A Difference in Patient Outcomes

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 30, 2012
Registry last updated
May 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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