CompletedPhase 4

Exparel for Postoperative Pain Management in Shoulder Surgery

United States70 participantsStarted 2015-06

Plain-language summary

The purpose of this study is to compare the effect of liposomal Bupivacaine infiltration into the shoulder to continues nerve block with Bupivacaine on postoperative pain control and functional outcomes.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients undergoing shoulder arthroplasty under general anesthesia * Patients undergoing open reduction internal fixation (ORIF) of a proximal humerus fracture under general anesthesia * Patients with American Society of Anesthesiologist (ASA) physical status classification of 1-3 * Patients meeting criteria for standard of care continuous peripheral nerve block (CPNB) per anesthesia guidelines. * Patients agreeing to be available for brief follow up telephone survey post- operatively and being mentally able to respond. * Patients available for follow up routine post-operative clinic visits, per standard of care. Exclusion Criteria: * Contraindications to regional anesthesia * Significant peripheral neuropathy or neurological disorder affecting the upper extremity * Contraindication to a component of multimodal analgesia * Pregnancy * Opioid tolerance * Cognitive or psychiatric condition that might affect patient assessment and/or inability to provide informed consent.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Quality of Analgesia

Timeframe: 30 days

Trial details

NCT IDNCT02472314

SponsorWayne State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-05

Results submitted2018-11-28

View on ClinicalTrials.gov More Fracture of Shoulder and Upper Arm trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.