Exparel and Dexamethasone
- Sponsor
- Duke University
- Study ID
- NCT07614802
- Phase
- PHASE4
- Status
- Not Yet Recruiting
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Conditions
- Postoperative Pain
- Shoulder Arthroscopic Surgeries
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Liposomal Bupivacaine with Bupivacaine — DRUGAdministration of an interscalene brachial plexus nerve block using 10 mL liposomal bupivacaine (133 mg) and 20 mL of 0.5% bupivacaine for postoperative analgesia following shoulder surgery.
- Dexamethasone — DRUG6 mg preservative-free dexamethasone
Study Details
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.
Key Dates
- First listed
- May 29, 2026
- Start date
- Aug 1, 2026
- Status verified
- May 2026
- Primary completion
- Aug 1, 2027
- Completion
- Sep 1, 2027
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Liposomal Bupivacaine AloneParticipants receive an interscalene brachial plexus nerve block consisting of 10 mL liposomal bupivacaine (133 mg) combined with 20 mL of 0.5% bupivacaine. This regimen represents standard of care for prolonged regional analgesia in shoulder surgery.
- Experimental: Liposomal Bupivacaine + DexamethasoneParticipants receive an interscalene brachial plexus nerve block consisting of 10 mL liposomal bupivacaine (133 mg) combined with 20 mL of 0.5% bupivacaine and 6 mg preservative-free dexamethasone. This arm evaluates whether the addition of dexamethasone prolongs sensory blockade duration compared to liposomal bupivacaine alone.
Primary Outcome Measure
time until resolution of sensory block [ Time Frame: 0-10 days ]
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