Post-operative Exparel Study Following Rotator Cuff Repair
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ClinicalTrials.gov Identifier: NCT04047745 |
Recruitment Status : Unknown
Verified August 2019 by Rothman Institute Orthopaedics.
Recruitment status was: Not yet recruiting
First Posted : August 7, 2019
Last Update Posted : August 7, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rotator Cuff Tears | Drug: Liposomal bupivacaine Drug: Ropivacaine injection | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 132 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | The Use of Liposomal Bupivacaine Interscalene Brachial Plexus Block for Rotator Cuff Surgery: A Randomized, Double Blind, Clinical Trial |
Estimated Study Start Date : | September 2019 |
Estimated Primary Completion Date : | September 2021 |
Estimated Study Completion Date : | September 2021 |

Arm | Intervention/treatment |
---|---|
Active Comparator: liposomal bupivacaine |
Drug: Liposomal bupivacaine
interscalene nerve block administered before surgery using 133 mg liposomal bupivacaine with 10mL 0.5% ropivacaine |
Active Comparator: ropivacaine |
Drug: Ropivacaine injection
interscale nerve block administered before surgery using 30mL 0.5% ropivacaine |
- opioid consumption [ Time Frame: surgery through 48 hours post-op ]postsurgical opioid consumption

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males and females aged 18 years or older with a full-thickness rotator cuff tear (confirmed on MRI) undergoing arthroscopic rotator cuff repair surgery.
- Anesthesiologists physical status 1, 2, or 3 and normal preoperative motor (Lovett scale: biceps, wrist, thumb) and sensory function.
Exclusion Criteria:
- Revision shoulder surgery
- History of more than 1 prior surgery performed on the operative shoulder
- Concomitant severe glenohumeral arthritis
- Concomitant adhesive capsulitis
- Worker's compensation claim
- Pregnancy
- History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics
- History of renal or hepatic failure
- Chronic neuromuscular deficit affecting the surgical limb.
- Uncontrolled psychiatric or neurologic disorder

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04047745
Contact: Director of Clinical Trials | 267-339-7818 | tiffany.morrison@rothmanortho.com |
United States, New Jersey | |
Rothman Orthopaedics at Egg Harbor Township | |
Egg Harbor Township, New Jersey, United States, 08234 |
Responsible Party: | Rothman Institute Orthopaedics |
ClinicalTrials.gov Identifier: | NCT04047745 |
Other Study ID Numbers: |
2019Tucker |
First Posted: | August 7, 2019 Key Record Dates |
Last Update Posted: | August 7, 2019 |
Last Verified: | August 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Rotator Cuff Injuries Rupture Wounds and Injuries Shoulder Injuries Tendon Injuries Bupivacaine Ropivacaine |
Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |