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Local Anesthetic

Exparel for Laparotomy

Phase 4
Waitlist Available
Led By Amanda Kumar, MD
Research Sponsored by Duke University
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 30 minutes after arrival to pacu, 8 hours, 24 hours, 36 hours, 48 hours and 72 hours post exparel administration
Awards & highlights

Study Summary

This trial will compare two types of pain relief after surgery, an epidural and a quadratus lumborum block, to see which works better.

Eligible Conditions
  • Laparotomy
  • Colectomy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes after arrival to post-anesthesia care unit (pacu), and at 8 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours and 168 hours post exparel administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes after arrival to post-anesthesia care unit (pacu), and at 8 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours and 168 hours post exparel administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cumulative opioid consumption over 48 hours
Other outcome measures
11-point Numeric Rating Scale (NRS-11)
Adverse Events
Block success
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Thoracic epidural analgesiaExperimental Treatment1 Intervention
Historical cohort that received thoracic epidural analgesia.
Group II: Quadratus lumborum blockExperimental Treatment1 Intervention
Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exparel
2014
Completed Phase 4
~1620

Find a Location

Who is running the clinical trial?

Pacira Pharmaceuticals, IncIndustry Sponsor
134 Previous Clinical Trials
13,885 Total Patients Enrolled
Duke UniversityLead Sponsor
2,356 Previous Clinical Trials
3,418,954 Total Patients Enrolled
Amanda Kumar, MDPrincipal InvestigatorDuke University
2 Previous Clinical Trials
72 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree can Exparel be considered a potential risk to patients?

"The safety of Exparel has been validated by the FDA, so it was assigned a score of 3."

Answered by AI

Could you point to any previous research that has been done on Exparel?

"Currently, there are 109 active clinical trials using Exparel with 18 being in the final phase of testing. While a large proportion of these studies are taking place near Philadelphia, Pennsylvania, participants can join at any one of 144 sites around the country."

Answered by AI

What is the current sample size of this clinical investigation?

"Affirmative. According to the information held on clinicaltrials.gov, this experiment is currently enrolling 30 patients from 1 medical facility. Its initiation was October 31st 2019 and its last update came July 22nd 2022 respectively."

Answered by AI

Are there still openings in this experimental project?

"Affirmative. According to clinicaltrials.gov, this scientific experiment is actively seeking volunteers and was initially published on October 31st 2019. The study's most recent edit took place on July 22nd 2022 and 30 participants are needed across 1 site."

Answered by AI

What conditions is Exparel commonly prescribed to treat?

"Exparel is often used to address pemphigus; additionally, it can also be employed for acute nonspecific tenosynovitis, general anesthesia and lupus erythematosus cell treatments."

Answered by AI

Does this research endeavor accept participants aged 25 and above?

"This medical research necessitates that individuals partaking in the study are aged between 18 and 85. Furthermore, there are specifically 13 trials for minors and 105 trials intended to benefit seniors."

Answered by AI

What criteria must an individual meet in order to be eligible for participation in this trial?

"This medical trial is open to 30 individuals with colectomy, ranging from 18 to 85 years old. Furthermore, the BMI must be between 18-35 kg/m^2 for a patient to qualify."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
QL Block With Exparel in Colectomy
2019. "QL Block With Exparel in Colectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03827291.
~8 spots leftby Apr 2025
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