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

February 3, 2021 updated by: ryan simovitch, Hospital for Special Surgery Florida

Liposomal Bupivacaine Plus Bupivacaine Peripheral Nerve Blockade Versus Ropivacaine Plus Dexamethasone Peripheral Nerve Blockade for Arthroscopic Rotator Cuff Repair: a Prospective Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

92

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • West Palm Beach, Florida, United States, 33401
        • HSS Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Drug: Liposomal bupivacaine
Injection of 10 ml of liposomal bupivacaine 1.3% (133 mg) for ultrasound guided interscalene block
Other Names:
  • Exparel
Drug: Bupivacaine Hcl 0.5% Inj
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.
Drug: Ropivacaine 0.5% Injectable Solution
Injection of 30 ml of ropivacaine 0.5% injectable solution for ultrasound guided interscalene block
Drug: Dexamethasone
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
Total opioid consumption in morphine milligram equivalents
Time Frame: 8 day period
Total opioid consumption for entire 8 days after surgery
8 day period
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.
up to 8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 18, 2019

Primary Completion (ACTUAL)

February 28, 2020

Study Completion (ACTUAL)

March 18, 2020

Study Registration Dates

First Submitted

January 23, 2021

First Submitted That Met QC Criteria

January 29, 2021

First Posted (ACTUAL)

February 4, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2021

Last Update Submitted That Met QC Criteria

February 3, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JMC0023RSOP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

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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