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Clinical Trials/NCT07614802
NCT07614802Not yet recruitingPhase 4

The Power Couple of Regional Analgesia? A Prospective Randomized Controlled Trial Comparing Block Duration With Liposomal Bupivacaine and Dexamethasone

Duke University0 sites80 target enrollmentStarted: August 1, 2026Last updated:
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Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
80
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This prospective randomized clinical trial evaluates the duration of sensory blockade in patients undergoing shoulder surgery receiving interscalene brachial plexus blocks with either liposomal bupivacaine alone or liposomal bupivacaine combined with dexamethasone.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Care Provider, Investigator, Outcomes Assessor)

Masking Description

Provider given care is not preparing study drug

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Adults aged 18 to 80 years
  • •ASA physical status 1-3
  • •Undergoing primary shoulder surgery with interscalene nerve block

Exclusion Criteria

  • •Revision shoulder surgery
  • •Daily chronic opioid use (over 3 months of continuous opioid use)
  • •Inability to communicate pain scores or need for analgesia
  • •Infection at the site of block placement
  • •Age under 18 years old or greater than 80 years old
  • •Pregnant women (as determined by point-of-care serum bHCG)
  • •Intolerance/allergy to local anesthetics
  • •Weight <50 kg
  • •severe pulmonary disease including chronic obstructive pulmonary disease and restrictive lung disease
  • •Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
  • •Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.
  • •Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.

Investigators

Sponsor
Duke University
Sponsor Class
Other
Responsible Party
Sponsor

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