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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01608035

Enrollment

Registered

2012-05-30

Start date

2012-09-30

Completion date

2015-07-31

Last updated

2016-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Ischemia, Phantom Limb Pain, Vascular Disease

Keywords

sciatic catheter, stump catheter, below knee amputation

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

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.

Interventions

PROCEDURESciatic catheter

presurgical sciatic catheter insertion

PROCEDUREStump catheter

intraoperative placed stump catheter

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026