A Phase 4 interventional study of Liposomal bupivacaine and Bupivacaine Hcl 0.5% Inj in Rotator Cuff Tears and Postoperative Pain, sponsored by Rothman Institute Orthopaedics. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-28.
Sponsored by Rothman Institute Orthopaedics · Phase 4, Interventional, and Treatment
Effective and safe control of pain after shoulder surgery is an important component of the post-surgical process. Patients who are comfortable in the early period after surgery are more satisfied with their experience and are better able to participate in rehabilitation exercises during their stay in the hospital. As surgeons and health care systems in the United States find themselves in the middle of an opioid epidemic, it is necessary to discover different options to provide patients pain relief that are both effective and safe in an effort to decrease the amount of pain medication used.
631 studies on the registry are indexed under Rotator Cuff Injuries; 156 are open to participants now.
This study's planned enrollment of 126 is above the median of 60 across 456 interventional studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →Rothman Institute Orthopaedics is the lead sponsor of 119 studies on the registry; 18 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants having rotator cuff repair surgery will receive Liposomal bupivacaine (Exparel) + bupivacaine given in their shoulder block before surgery.
Drug: Liposomal bupivacaine · Drug: Bupivacaine Hcl 0.5% Inj
Participants having rotator cuff repair surgery will receive Liposomal bupivacaine (Exparel) + Dexamethasone + bupivacaine given in their shoulder block before surgery.
Drug: Liposomal bupivacaine · Drug: Bupivacaine Hcl 0.5% Inj · Drug: Dexamethasone
20 mL Liposomal bupivacaine (Exparel) will be given in the shoulder block prior to surgery
0.75% bupivacaine will be given in the shoulder block prior to surgery
10 mg Dexamethasone will be given in the shoulder block prior to surgery
Postoperative narcotic medication use
Participants will be asked to record the amount of medication they take to control pain after surgery
Time frame: 14 days
Postoperative pain levels
This will be measured by providing participants the visual analog scale (VAS) questionnaire as well as a postoperative pain recording diary to complete after surgery
Time frame: 14 days
Start is estimated for Aug 2024; primary completion for Aug 2025, 12 months later.
Of 21 phase 4 interventional studies under Rotator Cuff Injuries, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 58. This study's planned 12 months is below that.
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Studies of the drug tested here: Dexamethasone
Rothman Institute Orthopaedics →