Peripheral Nerve Blocks for Major Lower Extremity Amputations

NCT03174782 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 20107050
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain

  Postoperative pain will be assessed by McGill questionaire

  6 months

Study Arms (2)

Treatment

ACTIVE COMPARATOR

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

Drug: Bupivacaine

Control

PLACEBO COMPARATOR

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.

Drug: Saline Solution

Interventions

Bupivacaine DRUG

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

Treatment

Saline Solution DRUG

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who require major lower extremity amputations

You may not qualify if:

• less than 18 years old, pregnant, emergency amputation, staged amputation, amputations performed by non-vascular surgeons, patients who are allergic to bupivacaine, patients who are unable to communicate symptoms of pain

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Community Regional Medical Center

Fresno, California, 93721, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Kamell Eckroth-Bernard
• Organization: University of California, San Francisco- Fresno

kamell.eckroth-bernard@ucsf.edu

559-431-6226

Study Officials

• Kamell Eckroth-Bernard, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: To randomize patients, consent forms will be pre-labeled with a random subject identification number. This number will serve as the participants' study ID for all data collection in order to maintain privacy and confidentiality. Additionally, this number will be linked to a sealed envelope containing the random treatment group. The study coordinator will create the labels and assemble the envelopes to ensure all investigators remain blind to the treatment groups. This sealed envelope will be given to the anesthesia providers for the amputation. The anesthesia team will then administer the assigned treatment prior to induction of general anesthesia. Half of the patients will be randomized into the treatment group, and half of the patients will be randomized into the control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 5, 2017
• Study Start: January 1, 2018
• Primary Completion: April 27, 2021
• Study Completion: April 27, 2021
• Last Updated: June 12, 2023
• Results First Posted: May 31, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)