Exparel v Dexamethasone in RCR
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Liposomal bupivacaine, Bupivacaine Hcl 0.5% Inj, Dexamethasone.
- Who it may be relevant to
- Registry conditions: Rotator Cuff Tears, Postoperative Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Single-Shot Liposomal Bupivacaine vs. Liposomal Bupivacaine Combined With Dexamethasone Following Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Trial
Overview
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.
Interventions
- Drug Liposomal bupivacaine
20 mL Liposomal bupivacaine (Exparel) will be given in the shoulder block prior to surgery - Drug Bupivacaine Hcl 0.5% Inj
0.75% bupivacaine will be given in the shoulder block prior to surgery - Drug Dexamethasone
10 mg Dexamethasone will be given in the shoulder block prior to surgery
Primary outcome measures
- Postoperative narcotic medication use [Time frame: 14 days]
- Postoperative pain levels [Time frame: 14 days]
Eligibility criteria
Inclusion criteria
- Participants having a primary rotator cuff repair
- Age 18 and older
- English speaking
- Ability to complete surveys by phone or in person
- Ability to provide informed consent
Exclusion criteria
- Revision rotator cuff repair (RCR) cases
- Participants having an open RCR
- Allergies and/or medical contra-indications to study medications
- Non-English speakers
- Participants who are pregnant, plan to become pregnant and do not utilize adequate contraceptive means, or are currently breastfeeding (all patients who have the potential to be pregnant are administered a urine beta-HCG pregnancy test, with suspected false-positive or equivocal urine pregnancy tests followed by a more specific serum pregnancy test)
- Rotator cuff repair needing Graft Augmentation
- Known alcohol or narcotic abuse history
- Existing contract with a pain specialist due to underlying preoperative pain syndrome
- Preoperative opioid use within the 3 months prior to surgery
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Rothman Orthopaedic Institute — Philadelphia
Identifiers
NCT: NCT06575010 · 2024-0726SNAM