Health TrialsbyHealthPanel

Exparel and Dexamethasone

ConditionsPostoperative PainShoulder Arthroscopic Surgeries
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 to 80 years

ASA physical status 1-3

Undergoing primary shoulder surgery with interscalene nerve block

Disqualifiers

ASA 4 or 5

Revision shoulder surgery

Daily chronic opioid use (over 3 months of continuous opioid use)

Inability to communicate pain scores or need for analgesia

Trial design

Design model

Parallel

Treatments tested in this trial

  • Liposomal Bupivacaine with Bupivacaine

    Drug

    Administration 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

    Drug

    6 mg preservative-free dexamethasone

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Liposomal Bupivacaine AloneActive comparator 1 intervention
Group B: Liposomal Bupivacaine + DexamethasoneExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

time until resolution of sensory block

Patients will be called daily until resolution of their sensory block

Time frame
0-10 days

Secondary outcomes

1

duration of motor blockade

Time frame
2, 12, 24, 36, 48, 72, and 96 hours postoperatively
2

pain scores (scale of 0-10)

Numeric Pain Rating Scale (NPRS): A score of 0 means "no pain," and 10 means "the worst pain imaginable

Time frame
2, 12, 24, 36, 48, 72, and 96 hours postoperatively
3

opioid consumption (in oral morphine equivalents)

Time frame
2, 12, 24, 36, 48, 72, and 96 hours postoperatively
4

known side effects of interscalene blocks

Time frame
2, 12, 24, 36, 48, 72, and 96 hours postoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: