Liposomal Bupivacaine Plus Bupivacaine Peripheral Nerve Blockade Versus Ropivacaine Plus Dexamethasone Peripheral Nerve Blockade for Arthroscopic Rotator Cuff Repair

NCT04737980 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: JMC0023RSOP
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a comparison of analgesia effect from peripheral nerve blockade (PNB) with liposomal bupivacaine combined with bupivacaine compared to PNB with ropivacaine combined with dexamethasone for arthroscopic rotator cuff repair.

Conditions

Rotator Cuff Tears; Shoulder Pain

Keywords

peripheral nerve block; interscalene nerve block; bupivacaine; liposomal bupivacaine; ropivacaine; dexamethasone

Outcome Measures

Primary Outcomes (4)

• Daily morphine milligram equivalents of opioid

  Daily opioid consumption reported as OMED

  up to 8 days

• Total opioid consumption in morphine milligram equivalents

  Total opioid consumption for entire 8 days after surgery

  8 day period

• Participant reported "worst pain" level on a numeric rating scale after surgery

  Worst pain level experienced as reported on a numeric rating scale by a participant for each preceding 24 hour period. 0 on numeric rating scale denoting no pain and 10 denoting worst possible pain.

  up to 8 days

• Overall benefit of anesthesia score (OBAS)

  Overall benefit of anesthesia score (OBAS) as reported by a participant for each preceding 24 hour period. OBAS is a numeric rating scale. A lower value denotes better pain control and less side effects from anesthesia. Range of scores from 0 to 28.

  up to 8 days

Secondary Outcomes (1)

• Change in pain from baseline

  up to 8 days

Study Arms (2)

Experimental Group: Interscalene block with liposomal bupivacaine combined with bupivacaine

EXPERIMENTAL

Interscalene nerve block was performed utilizing ultrasound guidance with infiltration of 10 ml of liposomal bupivacaine 1.3% (133 mg) combined with 10 ml of 0.5% bupivacaine hydrochloride.

Drug: Liposomal bupivacaine; Drug: Bupivacaine Hcl 0.5% Inj

Control Group: Interscalene block with ropivacaine combined with dexamethasone

ACTIVE COMPARATOR

Interscalene nerve block was performed utilizing ultrasound guidance with infiltration of 30ml of 0.5% ropivacaine combined with a 2 ml volume of 8mg of dexamethasone.

Drug: Ropivacaine 0.5% Injectable Solution; Drug: Dexamethasone

Interventions

Liposomal bupivacaine DRUG

Injection of 10 ml of liposomal bupivacaine 1.3% (133 mg) for ultrasound guided interscalene block

Also known as: Exparel

Experimental Group: Interscalene block with liposomal bupivacaine combined with bupivacaine

Bupivacaine Hcl 0.5% Inj DRUG

Injection of 10 ml of 0.5% bupivacaine hydrochloride as admixture for ultrasound guided interscalene block

Experimental Group: Interscalene block with liposomal bupivacaine combined with bupivacaine

Ropivacaine 0.5% Injectable Solution DRUG

Injection of 30 ml of ropivacaine 0.5% injectable solution for ultrasound guided interscalene block

Control Group: Interscalene block with ropivacaine combined with dexamethasone

Dexamethasone DRUG

Injection of 8mg (2ml) dexamethasone injectable as admixture

Control Group: Interscalene block with ropivacaine combined with dexamethasone

Eligibility Criteria

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

You may qualify if:

• Full thickness tears of the Supraspinatus tendon
• Combined full thickness tears of the Supraspinatus and Infraspinatus tendon

You may not qualify if:

• Age \< 18
• Revision surgery
• Chronic opioid use (\>3 months prior to surgery)
• Allergy to local anesthetics or opioids
• Workers compensation or medical legal claim
• Pulmonary disease
• NSAID intolerance
• Neurologic deficit of operative upper extremity
• Concomitant full thickness subscapularis tear
• tendon rotator cuff tear

Sponsors & Collaborators

• Hospital for Special Surgery Florida: lead

Study Sites (1)

HSS Florida

West Palm Beach, Florida, 33401, United States

Location

Related Publications (9)

• 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 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

• Abdallah FW, Halpern SH, Aoyama K, Brull R. Will the Real Benefits of Single-Shot Interscalene Block Please Stand Up? A Systematic Review and Meta-Analysis. Anesth Analg. 2015 May;120(5):1114-1129. doi: 10.1213/ANE.0000000000000688.

  PMID: 25822923 RESULT

• Namdari S, Nicholson T, Abboud J, Lazarus M, Steinberg D, Williams G. Interscalene Block with and without Intraoperative Local Infiltration with Liposomal Bupivacaine in Shoulder Arthroplasty: A Randomized Controlled Trial. J Bone Joint Surg Am. 2018 Aug 15;100(16):1373-1378. doi: 10.2106/JBJS.17.01416.

  PMID: 30106818 RESULT

• Namdari S, Nicholson T, Abboud J, Lazarus M, Steinberg D, Williams G. Randomized Controlled Trial of Interscalene Block Compared with Injectable Liposomal Bupivacaine in Shoulder Arthroplasty. J Bone Joint Surg Am. 2017 Apr 5;99(7):550-556. doi: 10.2106/JBJS.16.00296.

  PMID: 28375887 RESULT

• Kolade O, Patel K, Ihejirika R, Press D, Friedlander S, Roberts T, Rokito AS, Virk MS. Efficacy of liposomal bupivacaine in shoulder surgery: a systematic review and meta-analysis. J Shoulder Elbow Surg. 2019 Sep;28(9):1824-1834. doi: 10.1016/j.jse.2019.04.054. Epub 2019 Jul 16.

  PMID: 31324503 RESULT

• Yan Z, Chen Z, Ma C. Liposomal bupivacaine versus interscalene nerve block for pain control after shoulder arthroplasty: A meta-analysis. Medicine (Baltimore). 2017 Jul;96(27):e7226. doi: 10.1097/MD.0000000000007226.

  PMID: 28682872 RESULT

• Patel MA, Gadsden JC, Nedeljkovic SS, Bao X, Zeballos JL, Yu V, Ayad SS, Bendtsen TF. Brachial Plexus Block with Liposomal Bupivacaine for Shoulder Surgery Improves Analgesia and Reduces Opioid Consumption: Results from a Multicenter, Randomized, Double-Blind, Controlled Trial. Pain Med. 2020 Feb 1;21(2):387-400. doi: 10.1093/pm/pnz103.

  PMID: 31150095 RESULT

• Wang K, Zhang HX. Liposomal bupivacaine versus interscalene nerve block for pain control after total shoulder arthroplasty: A systematic review and meta-analysis. Int J Surg. 2017 Oct;46:61-70. doi: 10.1016/j.ijsu.2017.08.569. Epub 2017 Aug 24.

  PMID: 28843463 RESULT

MeSH Terms

Conditions

Rotator Cuff Injuries; Shoulder Pain

Interventions

Bupivacaine; Ropivacaine; Dexamethasone

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The participant was informed of which arm they were in after random draw as this information may have been important in the event they experienced side effects and needed to guide physician care at outside facilities. The anesthesiologist could not be masked regarding arm as the appearance of the medicine injected in both arms of the study was visibly different. The outcome assessor was masked by unique identifiers being applied to participants and outcome data kept separate from intervention arm until final analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director-Shoulder Service

Model Details: This study utilized two parallel arms for intervention. Participants were randomized to ultrasound guided PNB with liposomal bupivacaine combined with bupivacaine or PNB with ropivacaine combined with dexamethasone.

Study Record Dates

• First Submitted: January 23, 2021
• First Posted: February 4, 2021
• Study Start: July 18, 2019
• Primary Completion: February 28, 2020
• Study Completion: March 18, 2020
• Last Updated: February 8, 2021

Record last verified: 2021-02

Locations

US (1)