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Preoperative Regional Nerve Block for Acute and Chronic Post-Operative Pain Following Mastectomy

NCT04019834 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2022-08-03

No results posted yet for this study

Summary

The purpose of this study is to see if pre-operative regional nerve blocks compared to a placebo nerve block can decrease chronic post mastectomy pain, immediate postoperative pain and postoperative narcotic consumption.

Conditions

Interventions

DRUG

regional nerve block with local anesthesia of bupivacaine with steroid

Patient will receive titrated sedation with a combination of fentanyl and versed prior to the start of the block. An ultrasound will be used to identify the fascial planes for either pectoral, serratus, or erector spinae nerve blocks. A block needle will be passed into the fascial plane and injectate will be deposited. The injectate in the active arm will contain a combination of bupivacaine, epinephrine and dexamethasone.

OTHER

Placebo regional nerveblock with normal saline

Patients who are randomized to placebo will undergo the same procedure with the exception of injection of 10cc of normal saline into the subcutaneous tissue .

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Rachael B Lancaster, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-06
Primary Completion
2021-11-25
Completion
2021-11-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04019834 on ClinicalTrials.gov