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

NCT ID: NCT05900427

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-08
• Study Completion Date: 2026-03-01

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).

Detailed Description

Patients undergoing shoulder surgery can suffer from significant postoperative pain which can lead to an increase in recovery time, opioid use and potential dependency, and a decrease in quality of recovery. The interscalene brachial plexus block is a common effective regional anesthesia technique used for a variety of procedures involving the shoulder. The number of total shoulder arthroplasty surgeries being performed annually in the United States are increasing every year. Liposomal bupivacaine was FDA approved for use in patients undergoing interscalene block in 2018 to reduce postoperative pain from shoulder surgery. The information from the manufacturer indicates that the liposomal encapsulation may release the drug for up to approximately 72 hours after it has been administered, providing a prolonged analgesic effect. Evidence to the prolonged analgesic effect of liposomal bupivacaine has varied in the current literature. A recent meta-analysis suggested that liposomal bupivacaine may provide a statistically significant, but clinically insignificant decrease in opioid consumption and pain scores over time. The authors noted a possible limitation of their study is that the meta-analysis included a variety of surgical procedures and block techniques, and was not specific to shoulder surgery or interscalene block. The authors noted that this variability in anesthetic regimens between study groups could have affected the observed outcomes.

Recently, the investigators performed a retrospective quality improvement study to investigate the potential benefit of liposomal bupivacaine used for interscalene blocks among 491 patients undergoing shoulder arthroplasty between 2018 and 2021. The investigators compared the difference in the proportion of patients with clinically tolerable pain scores (defined as VAS ≤ 4) in those patients receiving liposomal bupivacaine vs. those receiving another local anesthetic (plain bupivacaine, mepivacaine or ropivacaine) vs. those receiving no block. The results of this study suggested there was significant difference in the proportion of patients with clinically tolerable pain scores when receiving liposomal bupivacaine during all observations and at 3 days postoperatively versus those patient that did not. The patients who received liposomal bupivacaine also had a significant reduction in morphine milligram equivalents (MMEs).

Based on the investigators retrospective results, the investigators performed a power analysis which allowed for the development of this prospective randomized double blinded trial comparing liposomal bupivacaine plus plain bupivacaine vs. plain bupivacaine only in near equipotent doses. The investigators believe that this is a very important and unique trial to perform as it could change the way pain management is delivered in this patient population. Longer acting local anesthetic used for interscalene blocks may increase the number of patients who have tolerable pain and require less or no opioids. This could reduce or inevitably eliminate the unwanted effects of opioids (nausea, vomiting, constipation, urinary retention, opioid induced respiratory depression, dependency and addiction) and result in an improvement in the quality of recovery of patients undergoing total shoulder arthroplasties.

Conditions

Total Shoulder Arthroplasty; Reverse Total Shoulder Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Liposomal Bupivacaine Group

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

Group Type: EXPERIMENTAL

Liposomal bupivacaine

Intervention Type: 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).

Plain Bupivacaine Group

36 mL (180 mg) 0.5% bupivacaine

Group Type: OTHER

Bupivacaine

Intervention Type: DRUG

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

Interventions

Liposomal bupivacaine

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).

Intervention Type: DRUG

Bupivacaine

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

Intervention Type: DRUG

Other Intervention Names

Exparel; Marcaine

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Endeavor Health

OTHER

Sponsor Role: collaborator

Johnny K. Lee

OTHER

Sponsor Role: lead

Responsible Party

Johnny K. Lee

M.D., FPA, Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Johnny K Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Endeavor Health

Locations

NorthShore University HealthSystem

Skokie, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Johnny K Lee, MD

Role: CONTACT

anesthesiaresearch@northshore.org

847-570-2760

Facility Contacts

Johnny Lee, MD

Role: primary

JLee8@northshore.org

847-570-2760

References

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.

Reference Type: BACKGROUND

PMID: 22323951 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21716734 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32858194 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22067185 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33372953 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36261261 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23411725 (View on PubMed)

Other Identifiers

EH23-069

Identifier Type: -

Identifier Source: org_study_id