- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04737980
Liposomal Bupivacaine Plus Bupivacaine Peripheral Nerve Blockade Versus Ropivacaine Plus Dexamethasone Peripheral Nerve Blockade for Arthroscopic Rotator Cuff Repair
Liposomal Bupivacaine Plus Bupivacaine Peripheral Nerve Blockade Versus Ropivacaine Plus Dexamethasone Peripheral Nerve Blockade for Arthroscopic Rotator Cuff Repair: a Prospective Randomized Trial
Study Overview
Status
Conditions
Detailed Description
Arthroscopic rotator cuff repair(ARCR) addresses dysfunction and pain in individuals with rotator cuff tears who have failed conservative management. These procedures are typically performed in an outpatient setting. Single shot PNB with long acting local anesthetics have become the foundation of modern multimodal analgesia protocols. The reported analgesic benefits of PNB for shoulder surgery include reduced pain scores, opioid consumption, post-operative nausea and vomiting, improved postoperative recovery and improvement of patient satisfaction. However, standard PNB with bupivacaine or ropivacaine have been associated with rebound pain resulting in a sudden onset of pain that can be refractory to treatment and often necessitates the use of significant quantities of opioids.
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Florida
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West Palm Beach, Florida, United States, 33401
- HSS Florida
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Full thickness tears of the Supraspinatus tendon
- Combined full thickness tears of the Supraspinatus and Infraspinatus tendon
Exclusion Criteria:
- 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
- 2 tendon rotator cuff tear
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
Injection of 10 ml of liposomal bupivacaine 1.3% (133 mg) for ultrasound guided interscalene block
Other Names:
Injection of 10 ml of 0.5% bupivacaine hydrochloride as admixture for ultrasound guided interscalene block
|
ACTIVE_COMPARATOR: 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.
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Injection of 30 ml of ropivacaine 0.5% injectable solution for ultrasound guided interscalene block
Injection of 8mg (2ml) dexamethasone injectable as admixture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily morphine milligram equivalents of opioid
Time Frame: up to 8 days
|
Daily opioid consumption reported as OMED
|
up to 8 days
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Total opioid consumption in morphine milligram equivalents
Time Frame: 8 day period
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Total opioid consumption for entire 8 days after surgery
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8 day period
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Participant reported "worst pain" level on a numeric rating scale after surgery
Time Frame: up to 8 days
|
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)
Time Frame: up to 8 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in pain from baseline
Time Frame: up to 8 days
|
Participant reported change in "worst pain" level on numeric rating scale from baseline (preoperative) "worst pain" to "worst pain" reported on each day after surgery.
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up to 8 days
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Wounds and Injuries
- Joint Diseases
- Musculoskeletal Diseases
- Rupture
- Shoulder Injuries
- Tendon Injuries
- Arthralgia
- Rotator Cuff Injuries
- Shoulder Pain
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Anesthetics, Local
- Dexamethasone
- Bupivacaine
- Ropivacaine
Other Study ID Numbers
- JMC0023RSOP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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