Liposomal Bupivacaine Plus Bupivacaine Peripheral Nerve Blockade Versus Ropivacaine Plus Dexamethasone Peripheral Nerve Blockade for Arthroscopic Rotator Cuff Repair
NCT ID: NCT04737980
Last Updated: 2021-02-08
Study Results
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Basic Information
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COMPLETED
PHASE4
92 participants
INTERVENTIONAL
2019-07-18
2020-03-18
Brief Summary
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Detailed Description
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Side effects of opioid consumption include nausea, vomiting, sedation, constipation, respiratory depression, hypotension, ileus, urinary retention, dehydration and addiction. It is therefore desirable to minimize the requirement for opioid consumption after ARCR.
Liposomal bupivacaine injectable suspension and its potential use for PNB has been a recent topic of interest in an effort to provide patients with longer acting pain control after shoulder surgery compared to the use of bupivacaine or ropivacaine. Liposomal bupivacaine has a delayed onset of action so its practical use for PNB for ARCR requires the additive of bupivacaine to reduce pain during and immediately after surgery as a bridge to the onset of liposomal bupivacaine.
The purpose of this study is to determine if PNB utilizing liposomal bupivacaine combined with bupivacaine performs favorably to standard PNB with ropivacaine combined with dexamethasone. Primary and secondary outcomes will be assessed including worst pain reported postoperatively on a numeric rating scale(NRS), postoperative opioid consumption reported as oral morphine equivalent dosage(OMED) and the overall benefit of anesthesia (OBAS) as reported by the OBAS score.
The hypothesis of this study is that PNB with liposomal bupivacaine combined with bupivacaine will translate to lower postoperative daily NRS pain scores, decreased daily and total OMED consumed and lower OBAS scores compared to PNB with ropivacaine combined with dexamethasone over the first 8 days following surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental Group: Interscalene block with liposomal bupivacaine combined with bupivacaine
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.
Liposomal bupivacaine
Injection of 10 ml of liposomal bupivacaine 1.3% (133 mg) for ultrasound guided interscalene block
Bupivacaine Hcl 0.5% Inj
Injection of 10 ml of 0.5% bupivacaine hydrochloride as admixture for ultrasound guided interscalene block
Control Group: Interscalene block with ropivacaine combined with dexamethasone
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.
Ropivacaine 0.5% Injectable Solution
Injection of 30 ml of ropivacaine 0.5% injectable solution for ultrasound guided interscalene block
Dexamethasone
Injection of 8mg (2ml) dexamethasone injectable as admixture
Interventions
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Liposomal bupivacaine
Injection of 10 ml of liposomal bupivacaine 1.3% (133 mg) for ultrasound guided interscalene block
Bupivacaine Hcl 0.5% Inj
Injection of 10 ml of 0.5% bupivacaine hydrochloride as admixture for ultrasound guided interscalene block
Ropivacaine 0.5% Injectable Solution
Injection of 30 ml of ropivacaine 0.5% injectable solution for ultrasound guided interscalene block
Dexamethasone
Injection of 8mg (2ml) dexamethasone injectable as admixture
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Combined full thickness tears of the Supraspinatus and Infraspinatus tendon
Exclusion Criteria
* 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
* 2 tendon rotator cuff tear
18 Years
ALL
Yes
Sponsors
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Hospital for Special Surgery Florida
OTHER
Responsible Party
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ryan simovitch
Director-Shoulder Service
Locations
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HSS Florida
West Palm Beach, Florida, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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JMC0023RSOP
Identifier Type: -
Identifier Source: org_study_id
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