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Peripheral Nerve Blocks for Major Lower Extremity Amputations

NCT03174782 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-06-12

Study results available
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Summary

This study will be a double-blinded randomized controlled trial analyzing all patients who will undergo major lower extremity amputations by the vascular surgery service at University of California, San Francisco (UCSF) Fresno between July 2017 and June 2018 to determine if regional nerve blocks (sciatic and femoral) have any effect on postoperative pain control, narcotic requirements, and length of stay compared with standard post-operative narcotic regimens.

Conditions

  • Postoperative Pain

Interventions

DRUG

Bupivacaine

Patients randomized to the treatment group will receive regional nerve blocks (sciatic and femoral) with bupivacaine at the dose of 1 mg/kg.

DRUG

Saline Solution

Patients randomized to the control group will receive two needle sticks (in the sciatic and femoral distributions) with normal saline to maintain the double-blinded investigation.

Sponsors & Collaborators

Principal Investigators

  • Kamell Eckroth-Bernard, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2021-04-27
Completion
2021-04-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03174782 on ClinicalTrials.gov