The Effect of Liposomal Bupivacaine Nerve Block (Exparel) in Rotator Cuff Surgery

NCT06139666 | Enrolling By Invitation Phase 4 DMC FDA Drug

• 1 other identifier: IRB 19-063
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate if there is a difference in pain after an arthroscopic rotator cuff surgery when a nerve block is performed with liposomal bupivacaine versus the standard treatment of bupivacaine alone. The main question aims to answer if patients who receive liposomal bupivacaine have better pain control and lower postoperative opioid consumption compared to bupivacaine alone. Participants be randomized to either the control group to receive a standard interscalene block with bupivacaine (25 cc of bupivacaine) or the experimental group to receive similar dosing of liposomal bupivacaine mixed with bupivacaine (10cc liposomal bupivacaine + 15cc bupivacaine). Data will be prospectively collected and the data from the experimental group will be compared to the control group at the completion of the study period.

Conditions

Rotator Cuff Tears; Postoperative Pain; Opioid Use

Keywords

Rotator Cuff Repair; Postoperative Pain Control; Orthopedic Surgery; Anesthesia; Nerve block; bupivacaine; Liposomal Bupivacaine

Outcome Measures

Primary Outcomes (1)

• Use of pain medications

  Patients will be asked to bring their bottle of pain medication prescribed after surgery to their first office visit so a narcotic pill count can be performed. Patients will record their pain pill consumption every day for 2 weeks in a study journal. The journal containing the pill count will be collected at the 2 week visit in the office. Opioid consumption will be quantified as milligram of opioid equivalents (MME).

  2 week postoperative visit

Secondary Outcomes (1)

• Pain severity

  Every day for the first 2 weeks, and a one-time survey at the 6 week and 12 week visit.

Study Arms (2)

Control- Bupivacaine Alone

ACTIVE COMPARATOR

patients will receive a standard interscalene block with bupivacaine alone (25 cc of bupivacaine)

Drug: Bupivacaine Injectable Solution

Study- Exparel

EXPERIMENTAL

patients will receive an interscalene block with Exparel solution, which is an extended-release formulation of bupivacaine consisting of 10cc liposomal bupivacaine mixed with 15cc bupivacaine. This is approved and used at the study institution

Drug: Exparel Injectable Solution

Interventions

Exparel Injectable Solution DRUG

Patients randomized to this arm will receive an interscalene block with Exparel solution, an extended-release formulation of bupivacaine (10cc liposomal bupivacaine + 15cc bupivacaine), approved for use at the study institution. This will be administered preoperatively on the day of surgery. The anesthesiologist administering the injection will be not be blinded to the mixture of injections (the surgeon and the patient will), which will be designated and randomized prior to administration. They will order and draw up the medication as they have been previously with no change in the standard of care. After surgery, the patient will be asked to keep a daily log of their pain scores, and the amount of narcotics will be counted by the physician at the first postoperative visit. The block would have been offered to the patient even if they are not part of the study. No additional visits are required. The only difference is the journal with pain score surveys and the pill count.

Study- Exparel

Bupivacaine Injectable Solution DRUG

Patients randomized to this arm will receive a standard interscalene block consisting of 25 cc of bupivacaine alone. This will be administered preoperatively on the day of surgery. The anesthesiologist administering the injection will not be blinded to the mixture of injections (the surgeon and the patient will), which will be designated and randomized prior to administration. They will order and draw up the medication as they have been previously with no change in the standard of care. After surgery, the patient will be asked to keep a daily log of their pain scores, and the amount of narcotics will be counted by the physician at the first postoperative visit. The block would have been offered to the patient even if they are not part of the study. No additional visits are required. The only difference is the journal with pain score surveys and the pill count.

Control- Bupivacaine Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients above 18 years of age
• Undergoing rotator cuff surgery or shoulder arthroscopy using an interscalene block

You may not qualify if:

• Patients with preexisting chronic obstructive pulmonary disease (COPD) or respiratory issues precluding the use of an interscalene block
• Pregnant women, women nursing infants
• Patients with preexisting liver disease
• Patients unwilling to have interscalene block performed
• Patients allergic to bupivacaine, liposomal bupivacaine, or any ingredients contained within the two drugs listed

Sponsors & Collaborators

• The Cooper Health System: lead

Study Sites (1)

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Related Publications (6)

• Kim DH, Liu J, Beathe JC, Lin Y, Wetmore DS, Kim SJ, Haskins SC, Garvin S, Oxendine JA, Ho MC, Allen AA, Popovic M, Gbaje E, Wu CL, Memtsoudis SG. Interscalene Brachial Plexus Block with Liposomal Bupivacaine versus Standard Bupivacaine with Perineural Dexamethasone: A Noninferiority Trial. Anesthesiology. 2022 Mar 1;136(3):434-447. doi: 10.1097/ALN.0000000000004111.

  PMID: 35041742 BACKGROUND

• Wiederhold BD, Garmon EH, Peterson E, Stevens JB, O'Rourke MC. Nerve Block Anesthesia. 2023 Apr 29. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK431109/

  PMID: 28613761 BACKGROUND

• Lonner JH, Scuderi GR, Lieberman JR. Potential utility of liposome bupivacaine in orthopedic surgery. Am J Orthop (Belle Mead NJ). 2015 Mar;44(3):111-7.

  PMID: 25750943 BACKGROUND

• Vyas KS, Rajendran S, Morrison SD, Shakir A, Mardini S, Lemaine V, Nahabedian MY, Baker SB, Rinker BD, Vasconez HC. Systematic Review of Liposomal Bupivacaine (Exparel) for Postoperative Analgesia. Plast Reconstr Surg. 2016 Oct;138(4):748e-756e. doi: 10.1097/PRS.0000000000002547.

  PMID: 27673545 BACKGROUND

• Kaye AD, Armstead-Williams C, Hyatali F, Cox KS, Kaye RJ, Eng LK, Farooq Anwar MA, Patel PV, Patil S, Cornett EM. Exparel for Postoperative Pain Management: a Comprehensive Review. Curr Pain Headache Rep. 2020 Oct 23;24(11):73. doi: 10.1007/s11916-020-00905-4.

  PMID: 33098008 BACKGROUND

• Fedorka CJ, Tornberg HN, Rivera-Pintado C, Gentile PM, Russo D, Boniello M, Hunter K, Desai R, Soni D, Kleiner MT, Dodson G. Liposomal Bupivacaine + Bupivacaine Versus Bupivacaine Interscalene Nerve Block Effect on Pain After Rotator Cuff Repair: A Randomized Control Trial. J Am Acad Orthop Surg. 2025 Dec 24. doi: 10.5435/JAAOS-D-25-01002. Online ahead of print.

  PMID: 41468585 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries; Pain, Postoperative

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Catherine J Fedorka, MD

  The Cooper Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Papers with equal numbers of either "E" for Exparel or "B" for Bupivacaine will be allocated to envelopes and shuffled for randomization. At the time of selection, the patient will be identified and allocated to their respective group dependent on what letter they get. This will take place in the preoperative visit and will be communicated to the anesthesia team prior to block taking place by the data spreadsheet so that the surgeon will be blinded to what treatment took place.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon, Assistant Professor of Orthopaedic Surgery, Assistant Program Director, Orthopaedic Surgery Residency Program

Model Details: Prospective, double-blinded (surgeon and patient) randomized therapeutic trial

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: November 18, 2023
• Study Start: July 11, 2019
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)