Liposomal Bupivacaine in Shoulder Arthroscopy

NCT04461028 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: 832346
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The research study is being conducted to see if using the liposomal Bupivacaine for the Interscalene block will improve the patient pain control and the whole patient's experience 48 hours after surgery when compared to using the regular Marcaine (bupivacaine hydrochloride) in addition to the dexamethasone. All preoperative, surgical, post-operative care in the recovery room, and discharge instructions will be the same as any other patient undergoing this surgery. Study procedures:

• GROUP 1 liposomal Bupivacaine - will receive a 20 ml mixture of 10 ml of Liposomal Bupivacaine 1.3% and 10 ml of Bupivacaine HCl 0.5%.
• GROUP 2 Bupivacaine with dexamethasone - will receive 20 ml of Bupivacaine HCl 0.5% with 4 mg of preservative-free dexamethasone. 4\. Patients will undergo general endotracheal anesthesia with inhaled anesthetic (Sevoflurane) for a goal MAC 1.0. Other than the aforementioned interscalene nerve block, patients will not receive any other local anesthetic. 5\. Patients will receive a multimodal analgesic and antiemetic regimen standardized for shoulder arthroscopies at our institution. Preoperatively, all patients will receive 300 mg of gabapentin and 1,000 mg of acetaminophen orally. Intraoperatively, patients will receive 4 mg of ondansetron and 15 mg of ketorolac intravenously. Postoperatively, patients will remain on an oral regimen of 300 mg of gabapentin three times daily for one week, and 1,000 mg of acetaminophen and 10 mg of ketorolac every 8 hours for 48 hours after surgery. 6\. Additional intraoperative or postoperative opioid analgesics will be administered as needed. Patients with a history of PONV or otherwise deemed high risk for PONV by the attending anesthesiologist will receive a scopolamine patch before induction of general anesthesia.

Conditions

Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery

  The primary outcome will be defined as the Quality of Recovery (QoR-15) score at 48 hours after surgery. There are 15 questions assessed on a scale of 0-10, 10 being the better outcome.

  48 Hours

Secondary Outcomes (6)

• Quality of Recovery

  24 hours

• Quality of Recovery

  1 Week

• Pain scores

  72 hours

• Opioid Use

  72 hours

• PACU LOS

  1 Day

Study Arms (2)

GROUP 1 Liposomal Bupivacaine

OTHER

Will receive a 20 ml mixture of 10 ml of Liposomal Bupivacaine 1.3% and 10 ml of Bupivacaine HCl 0.5%.

Drug: Liposomal bupivacaine

GROUP 2 Bupivacaine with dexamethasone

OTHER

Will receive 20 ml of Bupivacaine HCl 0.5% with 4 mg of preservative-free dexamethasone.

Drug: Bupivacaine with Dexamethasone Solution

Interventions

Liposomal bupivacaine DRUG

20 ml mixture of 10 ml of Liposomal Bupivacaine 1.3% and 10 ml of Bupivacaine HCl 0.5%.

Also known as: Exparel

GROUP 1 Liposomal Bupivacaine

Bupivacaine with Dexamethasone Solution DRUG

20 ml of Bupivacaine HCl 0.5% with 4 mg of preservative-free dexamethasone.

GROUP 2 Bupivacaine with dexamethasone

Eligibility Criteria

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

You may qualify if:

• physical ASA status I-III
• age greater than 18 years
• mental competency
• ability to provide informed consent for the study.

You may not qualify if:

• severe pulmonary disease including chronic obstructive pulmonary disease(COPD)
• home oxygen use
• a preexisting chronic pain syndrome (defined as daily opioid intake for more than three months prior to surgery)
• allergies to any of the study medications or any of the medications in the multimodal analgesic regimen
• an inability to receive a nerve block due to anticoagulation status infection
• nerve injury
• patient refusal.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (16)

• Warrender WJ, Syed UAM, Hammoud S, Emper W, Ciccotti MG, Abboud JA, Freedman KB. Pain Management After Outpatient Shoulder Arthroscopy: A Systematic Review of Randomized Controlled Trials. Am J Sports Med. 2017 Jun;45(7):1676-1686. doi: 10.1177/0363546516667906. Epub 2016 Oct 13.

  PMID: 27729319 BACKGROUND

• Uquillas CA, Capogna BM, Rossy WH, Mahure SA, Rokito AS. Postoperative pain control after arthroscopic rotator cuff repair. J Shoulder Elbow Surg. 2016 Jul;25(7):1204-13. doi: 10.1016/j.jse.2016.01.026. Epub 2016 Apr 11.

  PMID: 27079219 BACKGROUND

• Hughes MS, Matava MJ, Wright RW, Brophy RH, Smith MV. Interscalene brachial plexus block for arthroscopic shoulder surgery: a systematic review. J Bone Joint Surg Am. 2013 Jul 17;95(14):1318-24. doi: 10.2106/JBJS.L.01116. No abstract available.

  PMID: 23864181 BACKGROUND

• Pehora C, Pearson AM, Kaushal A, Crawford MW, Johnston B. Dexamethasone as an adjuvant to peripheral nerve block. Cochrane Database Syst Rev. 2017 Nov 9;11(11):CD011770. doi: 10.1002/14651858.CD011770.pub2.

  PMID: 29121400 BACKGROUND

• Kahn RL, Cheng J, Gadulov Y, Fields KG, YaDeau JT, Gulotta LV. Perineural Low-Dose Dexamethasone Prolongs Interscalene Block Analgesia With Bupivacaine Compared With Systemic Dexamethasone: A Randomized Trial. Reg Anesth Pain Med. 2018 Aug;43(6):572-579. doi: 10.1097/AAP.0000000000000817.

  PMID: 29889698 BACKGROUND

• Holland D, Amadeo RJJ, Wolfe S, Girling L, Funk F, Collister M, Czaplinski E, Ferguson C, Leiter J, Old J, MacDonald P, Dufault B, Mutter TC. Effect of dexamethasone dose and route on the duration of interscalene brachial plexus block for outpatient arthroscopic shoulder surgery: a randomized controlled trial. Can J Anaesth. 2018 Jan;65(1):34-45. doi: 10.1007/s12630-017-0989-7. Epub 2017 Nov 10.

  PMID: 29127558 BACKGROUND

• Tandoc MN, Fan L, Kolesnikov S, Kruglov A, Nader ND. Adjuvant dexamethasone with bupivacaine prolongs the duration of interscalene block: a prospective randomized trial. J Anesth. 2011 Oct;25(5):704-9. doi: 10.1007/s00540-011-1180-x. Epub 2011 Jun 17.

  PMID: 21681533 BACKGROUND

• Balocco AL, Van Zundert PGE, Gan SS, Gan TJ, Hadzic A. Extended release bupivacaine formulations for postoperative analgesia: an update. Curr Opin Anaesthesiol. 2018 Oct;31(5):636-642. doi: 10.1097/ACO.0000000000000648.

  PMID: 30074492 BACKGROUND

• Viscusi ER. Liposomal drug delivery for postoperative pain management. Reg Anesth Pain Med. 2005 Sep-Oct;30(5):491-6. doi: 10.1016/j.rapm.2005.05.001. No abstract available.

  PMID: 16135355 BACKGROUND

• Bowyer A, Jakobsson J, Ljungqvist O, Royse C. A review of the scope and measurement of postoperative quality of recovery. Anaesthesia. 2014 Nov;69(11):1266-78. doi: 10.1111/anae.12730. Epub 2014 Jun 2.

  PMID: 24888412 BACKGROUND

• Myles PS. Measuring quality of recovery in perioperative clinical trials. Curr Opin Anaesthesiol. 2018 Aug;31(4):396-401. doi: 10.1097/ACO.0000000000000612.

  PMID: 29846193 BACKGROUND

• Chazapis M, Walker EM, Rooms MA, Kamming D, Moonesinghe SR. Measuring quality of recovery-15 after day case surgery. Br J Anaesth. 2016 Feb;116(2):241-8. doi: 10.1093/bja/aev413.

  PMID: 26787793 BACKGROUND

• Myles PS, Hunt JO, Nightingale CE, Fletcher H, Beh T, Tanil D, Nagy A, Rubinstein A, Ponsford JL. Development and psychometric testing of a quality of recovery score after general anesthesia and surgery in adults. Anesth Analg. 1999 Jan;88(1):83-90. doi: 10.1097/00000539-199901000-00016.

  PMID: 9895071 BACKGROUND

• 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 BACKGROUND

• Myles PS, Reeves MD, Anderson H, Weeks AM. Measurement of quality of recovery in 5672 patients after anaesthesia and surgery. Anaesth Intensive Care. 2000 Jun;28(3):276-80. doi: 10.1177/0310057X0002800304.

  PMID: 10853209 BACKGROUND

• Myles PS, Myles DB, Galagher W, Chew C, MacDonald N, Dennis A. Minimal Clinically Important Difference for Three Quality of Recovery Scales. Anesthesiology. 2016 Jul;125(1):39-45. doi: 10.1097/ALN.0000000000001158.

  PMID: 27159009 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Nabil M Elkassabany, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The research assistant collecting the data as well the patient will be blinded to the nature of the group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: Randomization between Group 1 and Group 2

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: July 8, 2020
• Study Start: February 21, 2019
• Primary Completion: June 27, 2022
• Study Completion: June 27, 2022
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)