Sciatic Perineural Versus Stump Catheter for Below Knee Amputation

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Ischemia, Phantom Limb Pain, Vascular Disease, Chronic Pain

Intervention / Treatment
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* Procedure: Sciatic catheter
* Procedure: Stump catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sciatic catheter<br> | Procedure: Sciatic catheter<br>* presurgical sciatic catheter insertion<br>* Other names: anesthesiologist placed catheter;|
| Active Comparator: Stump catheter<br> | Procedure: Stump catheter<br>* intraoperative placed stump catheter<br>* Other names: surgeon placed catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | MAR records will be used to calculate opioid consumption | Post-op day 0-7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score | VAS will be used (0-10) | Post-op day 0-7 and at 3months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sciatic catheter, stump catheter, below knee amputation