Peripheral Nerve Blocks for Major Lower Extremity Amputations
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ClinicalTrials.gov Identifier: NCT03174782 |
Recruitment Status :
Recruiting
First Posted : June 5, 2017
Last Update Posted : February 17, 2020
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Condition or disease | Intervention/treatment | Phase |
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Postoperative Pain | Drug: Bupivacaine Drug: Saline Solution | Phase 4 |

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 |

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.
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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.
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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. |
- Postoperative Pain [ Time Frame: 6 months ]Postoperative pain will be assessed by McGill questionaire

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

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
Contact: Huy Hoang, MD | (559) 499-6400 | hhoang@fresno.ucsf.edu |
United States, California | |
Community Regional Medical Center | Recruiting |
Fresno, California, United States, 93721 |
Principal Investigator: | Kamell Eckroth-Bernard, MD | University of California, San Francisco |
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 |
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 |
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 |