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

Primary Purpose

Rotator Cuff Tears, Shoulder Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Liposomal bupivacaine
Bupivacaine Hcl 0.5% Inj
Ropivacaine 0.5% Injectable Solution
Dexamethasone
Sponsored by
Hospital for Special Surgery Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears focused on measuring peripheral nerve block, interscalene nerve block, bupivacaine, liposomal bupivacaine, ropivacaine, dexamethasone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • HSS Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group: Interscalene block with liposomal bupivacaine combined with bupivacaine

Control Group: Interscalene block with ropivacaine combined with dexamethasone

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Daily morphine milligram equivalents of opioid
Daily opioid consumption reported as OMED
Total opioid consumption in morphine milligram equivalents
Total opioid consumption for entire 8 days after surgery
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.
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.

Secondary Outcome Measures

Change in pain from baseline
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.

Full Information

First Posted
January 23, 2021
Last Updated
February 3, 2021
Sponsor
Hospital for Special Surgery Florida
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1. Study Identification

Unique Protocol Identification Number
NCT04737980
Brief Title
Liposomal Bupivacaine Plus Bupivacaine Peripheral Nerve Blockade Versus Ropivacaine Plus Dexamethasone Peripheral Nerve Blockade for Arthroscopic Rotator Cuff Repair
Official Title
Liposomal Bupivacaine Plus Bupivacaine Peripheral Nerve Blockade Versus Ropivacaine Plus Dexamethasone Peripheral Nerve Blockade for Arthroscopic Rotator Cuff Repair: a Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 18, 2019 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
March 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital for Special Surgery Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears, Shoulder Pain
Keywords
peripheral nerve block, interscalene nerve block, bupivacaine, liposomal bupivacaine, ropivacaine, dexamethasone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group: Interscalene block with liposomal bupivacaine combined with bupivacaine
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group: Interscalene block with ropivacaine combined with dexamethasone
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Other Intervention Name(s)
Exparel
Intervention Description
Injection of 10 ml of liposomal bupivacaine 1.3% (133 mg) for ultrasound guided interscalene block
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hcl 0.5% Inj
Intervention Description
Injection of 10 ml of 0.5% bupivacaine hydrochloride as admixture for ultrasound guided interscalene block
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.5% Injectable Solution
Intervention Description
Injection of 30 ml of ropivacaine 0.5% injectable solution for ultrasound guided interscalene block
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Injection of 8mg (2ml) dexamethasone injectable as admixture
Primary Outcome Measure Information:
Title
Daily morphine milligram equivalents of opioid
Description
Daily opioid consumption reported as OMED
Time Frame
up to 8 days
Title
Total opioid consumption in morphine milligram equivalents
Description
Total opioid consumption for entire 8 days after surgery
Time Frame
8 day period
Title
Participant reported "worst pain" level on a numeric rating scale after surgery
Description
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.
Time Frame
up to 8 days
Title
Overall benefit of anesthesia score (OBAS)
Description
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.
Time Frame
up to 8 days
Secondary Outcome Measure Information:
Title
Change in pain from baseline
Description
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.
Time Frame
up to 8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
HSS Florida
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27079219
Citation
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.
Results Reference
result
PubMed Identifier
33372953
Citation
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.
Results Reference
result
PubMed Identifier
25822923
Citation
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.
Results Reference
result
PubMed Identifier
30106818
Citation
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.
Results Reference
result
PubMed Identifier
28375887
Citation
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.
Results Reference
result
PubMed Identifier
31324503
Citation
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.
Results Reference
result
PubMed Identifier
28682872
Citation
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.
Results Reference
result
PubMed Identifier
31150095
Citation
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.
Results Reference
result
PubMed Identifier
28843463
Citation
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.
Results Reference
result

Learn more about this trial

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

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