Skip to main content
OpenTrials
Completed

NCT Number: NCT04737980

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

HSS Florida

West Palm Beach, Florida, 33401, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liposomal bupivacaine

Drug

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

Other names: Exparel

Bupivacaine Hcl 0.5% Inj

Drug

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

Ropivacaine 0.5% Injectable Solution

Drug

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

Dexamethasone

Drug

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

Primary outcomes

  1. Daily morphine milligram equivalents of opioid

    Time frame: up to 8 days

    Daily opioid consumption reported as OMED

  2. Total opioid consumption in morphine milligram equivalents

    Time frame: 8 day period

    Total opioid consumption for entire 8 days after surgery

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery Florida

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 4, 2021
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.