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Exparel for Postoperative Pain

Phase 4
Recruiting
Led By Anna Ng-Pellegrino
Research Sponsored by St. Luke's Hospital, Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult patients undergoing elective orthopaedic foot and ankle surgery at a single institution
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial found that the use of Exparel in addition to a local anesthetic did not improve pain control or decrease opioid use in patients undergoing foot and ankle surgery when compared to local anesthetic alone.

Who is the study for?
This trial is for adults who need elective foot and ankle surgery, can speak English, and are able to consent. It's not for those having emergency surgery, non-English speakers, or individuals unable to make medical decisions.Check my eligibility
What is being tested?
The study tests Exparel in nerve blocks versus standard care without it during foot and ankle surgeries. The goal is to see if Exparel improves pain control and reduces the need for opioids after surgery.See study design
What are the potential side effects?
Exparel may cause side effects like nausea, constipation, vomiting, fever; however specific side effects related to its use in nerve blocks will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Adults having planned foot and ankle surgery at one hospital.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Duration of block
Secondary outcome measures
PROMIS Scores
number of opioid pills used by postoperative day # 4
Morphine

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Peripheral Nerve Block with ExparelExperimental Treatment1 Intervention
Liposomal bupivicaine administered for peripheral nerve block: mixed with 0.25-0.5% bupivacaine
Group II: Local Infiltration of ExparelExperimental Treatment1 Intervention
Liposomal bupivicaine administered by surgeon intra-operatively in field block, mix with 0.25% bupivacaine
Group III: Peripheral Nerve Block Without ExparelActive Control1 Intervention
Lower extremity peripheral nerve block without Exparel: 0.25-0.5% bupivacaine
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?

St. Luke's Hospital, PennsylvaniaLead Sponsor
18 Previous Clinical Trials
2,926 Total Patients Enrolled
1 Trials studying Postoperative Pain
52 Patients Enrolled for Postoperative Pain
Anna Ng-PellegrinoPrincipal InvestigatorSt. Luke's Hospital and Health Network, Pennsylvania

Media Library

Exparel Clinical Trial Eligibility Overview. Trial Name: NCT05494645 — Phase 4
Postoperative Pain Research Study Groups: Peripheral Nerve Block with Exparel, Peripheral Nerve Block Without Exparel, Local Infiltration of Exparel
Postoperative Pain Clinical Trial 2023: Exparel Highlights & Side Effects. Trial Name: NCT05494645 — Phase 4
Exparel 2023 Treatment Timeline for Medical Study. Trial Name: NCT05494645 — Phase 4

Frequently Asked Questions

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

Is the recruitment process for this research still ongoing?

"Affirmative. According to the data available on clinicaltrials.gov, this medical trial commenced recruiting patients in June 2022 and was amended as recently as August 8th of the same year. The research is currently attempting to enrol 300 individuals at a single site."

Answered by AI

Is Exparel a reliable and safe option for medical treatments?

"Considering that the Exparel trial is in its fourth phase, our team concluded it was safe enough to grant a score of 3."

Answered by AI

To what extent has recruitment been conducted for this research endeavor?

"Affirmative. According to clinicaltrials.gov, this medical trial is now recruiting volunteers; it was initially posted on June 1st 2022 and recently updated on August 8th 2022. 300 patients are required at one single site for the study's completion."

Answered by AI
~109 spots leftby Mar 2025