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Peripheral Nerve Blocks for Major Lower Extremity Amputations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03174782
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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 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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Bupivacaine Drug: Saline Solution Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Peripheral Nerve Blocks for Major Lower Extremity Amputations
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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

Placebo Comparator: Control
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
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.




Primary Outcome Measures :
  1. Postoperative Pain [ Time Frame: 6 months ]
    Postoperative pain will be assessed by McGill questionaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients who require major lower extremity amputations

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03174782


Contacts
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Contact: Huy Hoang, MD (559) 499-6400 hhoang@fresno.ucsf.edu

Locations
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United States, California
Community Regional Medical Center Recruiting
Fresno, California, United States, 93721
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Kamell Eckroth-Bernard, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03174782    
Other Study ID Numbers: 20107050
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents