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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rotator Cuff Tears, Shoulder Pain

Intervention / Treatment
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* Drug: Liposomal bupivacaine
* Drug: Bupivacaine Hcl 0.5% Inj
* Drug: Ropivacaine 0.5% Injectable Solution
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group: Interscalene block with liposomal bupivacaine combined with bupivacaine<br>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<br>* Injection of 10 ml of liposomal bupivacaine 1.3% (133 mg) for ultrasound guided interscalene block<br>* Other names: Exparel;Drug: Bupivacaine Hcl 0.5% Inj<br>* Injection of 10 ml of 0.5% bupivacaine hydrochloride as admixture for ultrasound guided interscalene block<br>|
| Active Comparator: Control Group: Interscalene block with ropivacaine combined with dexamethasone<br>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<br>* Injection of 30 ml of ropivacaine 0.5% injectable solution for ultrasound guided interscalene block<br>Drug: Dexamethasone<br>* Injection of 8mg (2ml) dexamethasone injectable as admixture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily morphine milligram equivalents of opioid | Daily opioid consumption reported as OMED | up to 8 days | 
| Total opioid consumption in morphine milligram equivalents | Total opioid consumption for entire 8 days after surgery | 8 day period | 
| 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. | up to 8 days | 
| 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. | up to 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 8 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral nerve block, interscalene nerve block, bupivacaine, liposomal bupivacaine, ropivacaine, dexamethasone