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Local Anesthetic

regional nerve block with local anesthesia of bupivacaine with steroid for Drug Abuse (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)
Awards & highlights

RELIEF Trial 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
  • Drug Abuse
  • Local Anesthesia
  • Mastectomy
  • Breast Cancer

RELIEF Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Postoperative Pain
Postoperative Pain: Brief Pain Inventory- Short Form (BPI-SF)
Secondary outcome measures
Postoperative length of stay
Postoperative narcotic consumption
Postoperative nausea

RELIEF 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

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,589 Previous Clinical Trials
2,280,333 Total Patients Enrolled
Rachael B Lancaster, MDPrincipal InvestigatorUniversity of Alabama at Birmingham

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Preoperative Regional Nerve Block for Acute and Chronic Post-Operative Pain Following Mastectomy
Rachael Lancaster, MD 2020. "Preoperative Regional Nerve Block for Acute and Chronic Post-Operative Pain Following Mastectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04019834.
~4 spots leftby Apr 2025
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