Effects on Postoperative Pain of Liposomal Bupivacaine in Interscalene Blocks for Total Shoulder Arthroplasty Patients

NCT05900427 | Terminated Phase 4 DMC FDA Drug

• 1 other identifier: EH23-069
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to compare the difference in the proportion of patients with tolerable pain scores, VAS pain scores, quality of recovery and opioid use in milligram equivalents (at 24, 48, 72, 96 and 120 hours postoperatively) in patients undergoing shoulder arthroplasty who receive interscalene blocks with or without Liposomal Bupivacaine. This is a prospective randomized, double-blinded, controlled trial that will enroll 130 subjects undergoing total shoulder arthroplasty or reverse total shoulder arthroplasty. Participants who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either 36 mL of 0.5% bupivacaine (PB group) or 10 mL of liposomal bupivacaine and 20 mL of 0.25 % bupivacaine and 6 mL of saline (LB group).

Conditions

Total Shoulder Arthroplasty; Reverse Total Shoulder Arthroplasty

Outcome Measures

Primary Outcomes (1)

• The difference in the proportion of patients with clinically significant tolerable pain scores

  The investigators will collect the difference in the proportion of patients with clinically significant tolerable pain scores (defined as Visual Analogue Scale (VAS) ≤ 4) post-op Day One in those patients receiving an interscalene block with liposomal bupivacaine with plain bupivacaine vs. plain bupivacaine. Subjects will rate their pain level on a scale of 0-10. Number "0" indicates no pain and number "10" indicates terrible pain.

  at Post-operative Day 1

Secondary Outcomes (6)

• The difference in the proportion of clinical tolerable pain scores in each group

  on Post-operative Day 2, Day 3, Day 4, and Day 5

• The difference in Visual Analogue Scale (VAS) pain scores (0 - 10)

  Upon Post Anesthesia Care Unit (PACU) admission; Day 0; Post-operative Day 1, Day 2, Day 3, Day 4, and Day 5.

• The difference in quality of recovery survey-15 responses

  on Post-operative Day 1, Day 2, Day 3, Day 4 and Day 5.

• Opioid use in morphine milligram equivalents (MME)

  on day of surgery; on Post-operative Day 1, Day 2, Day 3, Day 4, and Day 5

• Use of non-opioid analgesics

  on day of surgery; on Post-operative Day 1, Day 2, Day 3, Day 4, and Day 5

Study Arms (2)

Liposomal Bupivacaine Group

EXPERIMENTAL

10 mL (133 mg) Liposomal bupivacaine and 20 mL (50 mg) 0.25% bupivacaine and 6 mL of saline (183 mg)

Drug: Liposomal bupivacaine

Plain Bupivacaine Group

OTHER

36 mL (180 mg) 0.5% bupivacaine

Drug: Bupivacaine

Interventions

Liposomal bupivacaine DRUG

Subjects randomized to the Liposomal bupivacaine group will receive 10 mL (133 mg) of Liposomal bupivacaine and 20 mL (50 mg) of 0.25% bupivacaine and 6 mL of saline (183 mg).

Also known as: Exparel

Liposomal Bupivacaine Group

Bupivacaine DRUG

Subjects randomized to the Plain Bupivacaine group will receive 36 mL (180 mg) of 0.5% bupivacaine.

Also known as: Marcaine

Plain Bupivacaine Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject ages 18-90 years old
• Male or Female subjects
• Weight ≥ 60 kg.
• Must be able to consent in English

You may not qualify if:

• Ages: \<18 and \>90
• Weight \< 60 kg
• Multiple surgeries during one hospital stay
• Emergency surgery
• Allergy or any contraindication to local anesthetics used in trial.
• Pregnancy
• Contraindicated for use of liposomal bupivacaine
• Severe liver/kidney disease
• Defined as a diagnosis of end-stage renal disease (ESRD) defined as being on dialysis
• Subject who received another local anesthetic block prior to the interscalene block.
• Unable to consent in English

Sponsors & Collaborators

• Johnny K. Lee: lead
• Endeavor Health: collaborator

Study Sites (1)

NorthShore University HealthSystem

Skokie, Illinois, 60076, United States

Location

Related Publications (7)

• Lee HY, Kim SH, So KY, Kim DJ. Effects of interscalene brachial plexus block to intra-operative hemodynamics and postoperative pain for arthroscopic shoulder surgery. Korean J Anesthesiol. 2012 Jan;62(1):30-4. doi: 10.4097/kjae.2012.62.1.30. Epub 2012 Jan 25.

  PMID: 22323951 RESULT

• Mirza F, Brown AR. Ultrasound-guided regional anesthesia for procedures of the upper extremity. Anesthesiol Res Pract. 2011;2011:579824. doi: 10.1155/2011/579824. Epub 2011 May 30.

  PMID: 21716734 RESULT

• Best MJ, Aziz KT, Wilckens JH, McFarland EG, Srikumaran U. Increasing incidence of primary reverse and anatomic total shoulder arthroplasty in the United States. J Shoulder Elbow Surg. 2021 May;30(5):1159-1166. doi: 10.1016/j.jse.2020.08.010. Epub 2020 Aug 26.

  PMID: 32858194 RESULT

• Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011 Dec;54(12):1552-9. doi: 10.1097/DCR.0b013e318232d4c1.

  PMID: 22067185 RESULT

• Hussain N, Brull R, Sheehy B, Essandoh MK, Stahl DL, Weaver TE, Abdallah FW. Perineural Liposomal Bupivacaine Is Not Superior to Nonliposomal Bupivacaine for Peripheral Nerve Block Analgesia. Anesthesiology. 2021 Feb 1;134(2):147-164. doi: 10.1097/ALN.0000000000003651.

  PMID: 33372953 RESULT

• Elmer DA, Coleman JR, Renwick CM, Amato PE, Werner BC, Brockmeier SF, Slee AE, Hanson NA. Comparing bupivacaine alone to liposomal bupivacaine plus bupivacaine in interscalene blocks for total shoulder arthroplasty: a randomized, non-inferiority trial. Reg Anesth Pain Med. 2023 Jan;48(1):1-6. doi: 10.1136/rapm-2022-103997. Epub 2022 Oct 19.

  PMID: 36261261 RESULT

• Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.

  PMID: 23411725 RESULT

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Johnny K Lee, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The study drug was prepared by the attending anesthesiologist and overseen by the assigned research team member to confirm the dosage. Since it is a standard of care at our institution during regional anesthesia to aspirate prior to any injection to ensure that the needle is not intra-vascular, the anesthesiologist must be able to visualize the tubing and syringe prior to injection. Therefore, the tubing has to be transparent. Because liposomal bupivacaine is white in color and plain bupivacaine is clear, it would be impractical to blind the anesthesiologist in the study. All possible measures were taken to restrict the blinding to all personnel except the anesthesiologist and anesthesia research team member by limiting personnel in the room for the block procedure and documenting the administered block medication as "Study Drug" in the medical record. All other individuals, including the surgical team, pre and postoperative nursing staff, statisticians, and subject were blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., FPA, Principal Investigator

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 12, 2023
• Study Start: September 8, 2023
• Primary Completion: October 5, 2025
• Study Completion: December 1, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)