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Local Anesthetic

liposomal bupivacaine single-shot interscalene blockade for Postoperative Pain

Phase 4

Waitlist Available

Led By Jason K Panchamia, DO

Research Sponsored by Mayo Clinic

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 up to post-operative day 7

Awards & highlights

Study Summary

This trial will compare the effectiveness of two methods of pain relief after shoulder surgery.

Eligible Conditions

Postoperative Pain
Brachial Plexus Blocks

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to post-operative day 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to post-operative day 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to post-operative day 7 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 Intensity Score at Rest at 24 Hours Post-operatively

Secondary outcome measures

Cumulative Opioid Consumption

Quality of Recovery Score (QoR)

Trial Design

2Treatment groups

Active Control

Group I: liposomal bupivacaine single-shot interscalene blockadeActive Control1 Intervention

Subjects will receive a preoperative single-injection interscalene nerve block with long-acting numbing medicine, liposomal bupivacaine

Group II: continuous interscalene nerve blockadeActive Control1 Intervention

Subjects will receive a preoperative interscalene nerve block with a continuous catheter device which provides local anesthetic, bupivacaine, for up to 3 days.

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Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,206 Previous Clinical Trials

3,766,995 Total Patients Enrolled

3 Trials studying Postoperative Pain

274 Patients Enrolled for Postoperative Pain

Jason K Panchamia, DOPrincipal InvestigatorMayo Clinic

1 Previous Clinical Trials

125 Total Patients Enrolled

Frequently Asked Questions

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

What type of condition is continuous interscalene nerve blockade typically employed for?

"Continuous interscalene nerve blockade can be utilized to manage symptoms of perphigus, acute nonspecific tenosynovitis, and general anesthesia."

Answered by AI

Has the FDA granted approval for continuous interscalene nerve blockade?

"As this procedure has already been approved, our team at Power rated its safety as a 3—the highest rating possible."

Answered by AI

What other studies have probed the efficacy of continuous interscalene nerve blockade?

"Currently, there are 109 active trials researching continuous interscalene nerve blockade with 18 of those in Phase 3. Philadelphia, Pennsylvania has the most experiments happening but 144 locations across the country have been enlisted to participate."

Answered by AI

Could you confirm if this research endeavor is still accepting participants?

"According to information posted on clinicaltrials.gov, this medical trial is actively recruiting for its patient cohort. The initial listing was created 14th October 2021 and the page has had recent updates as of 14th October 2022."

Answered by AI

How many participants are being administered treatment as part of this research effort?

"Affirmative. The clinical trial database indicates that this is currently recruiting participants, having been first posted on October 14th 2021 and last updated on the same date in 2022. A total of 88 individuals are required for enrollment from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Liposomal Bupivacaine Single-Injection Interscalene Block vs. Continuous Interscalene Block for Primary Total Shoulder Arthroplasty

Jason K. Panchamia, D.O. 2021. "Liposomal Bupivacaine Single-Injection Interscalene Block vs. Continuous Interscalene Block for Primary Total Shoulder Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05005260.