Preoperative Regional Nerve Block for Acute and Chronic Post-Operative Pain Following Mastectomy (RELIEF Trial)

Phase < 1

Waitlist Available

Led By Rachael B Lancaster, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (day of surgery) to discharge (approximately 2 to 30 days post surgery)

Summary

This trial is testing whether a nerve block before surgery can reduce chronic pain and the need for painkillers afterwards for people who have had a mastectomy.

Eligible Conditions

Breast Cancer
Local Anesthesia
Drug Abuse
Mastectomy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day of surgery) to discharge (approximately 2 to 30 days post surgery)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day of surgery) to discharge (approximately 2 to 30 days post surgery)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day of surgery) to discharge (approximately 2 to 30 days post surgery) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Postoperative Pain

Postoperative Pain: Brief Pain Inventory- Short Form (BPI-SF)

Secondary study objectives

Postoperative length of stay

Postoperative narcotic consumption

Postoperative nausea

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: regional nerve block with local anesthesiaExperimental Treatment1 Intervention

Treatment Arm (n=55) 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 and perform regional nerve blocks. A block needle will be passed into the fascial plane an injectate will be deposited . The injectate in the active arm will contain a local anesthestic and dexamethasone.

Group II: regional nerve block with normal salinePlacebo Group1 Intervention

Placebo Comparator Arm (n=55). Patients will undergo the same procedure with the exception of injection of 10cc of normal saline into the subcutaneous tissue.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

regional nerve block with local anesthesia of bupivacaine with steroid

2020

Completed Early Phase 1

~30

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