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Exparel for Pain

Phase 4
Waitlist Available
Led By Pedram Bral, M.D.
Research Sponsored by Maimonides Medical Center
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 48 hours
Awards & highlights

Study Summary

The aim of the of the study is a reduction in minimally invasive supracervical hysterectomy postsurgical pain, which may result in less need for supplemental opioid pain medications, fewer opioid related adverse events, and a better recovery experience for patients, which may offer an economic benefit to health care systems. Intracervical preoperative dose of Exparel during minimally invasive (robotic--assisted or traditional laparoscopy) supracervical hysterectomy reduces cumulative pain scores for up to 24 hours and reduces overall requests for break through (additional) analgesia with opioid consumption compared with placebo.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain at 12 Hours
Pain at 48 Hours
Secondary outcome measures
Patients with additional pain medications

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ExparelExperimental Treatment1 Intervention
Group B (study, n=26) to receive 20ml of liposomal bupivacaine (EXPAREL) into the stroma of the cervix at the 4 and 8 o'clock positions (innervation insertion points of the cervix).
Group II: Saline Solution for InjectionActive Control1 Intervention
Group A (control, n=26) to receive 20ml of saline while prepping. The syringe will covered as to disguise the contents of the syringe.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
FDA approved

Find a Location

Who is running the clinical trial?

Maimonides Medical CenterLead Sponsor
69 Previous Clinical Trials
15,235 Total Patients Enrolled
1 Trials studying Pain
22 Patients Enrolled for Pain
Pedram Bral, M.D.Principal InvestigatorMinimally Invasive Surgery -Fellowship Director
1 Previous Clinical Trials
74 Total Patients Enrolled

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
EXPAREL for Minimally Invasive Supracervical Hysterectomies
Antonios Likourezos 2018. "EXPAREL for Minimally Invasive Supracervical Hysterectomies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03769714.
~9 spots leftby Apr 2025
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