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

Sponsor

Hospital for Special Surgery Florida (Other)

Overall Status

Completed

CT.gov ID

NCT04737980

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

11.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Tears Shoulder Pain	Drug: Liposomal bupivacaine Drug: Bupivacaine Hcl 0.5% Inj Drug: Ropivacaine 0.5% Injectable Solution Drug: Dexamethasone	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (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.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 18, 2019

Actual Primary Completion Date :

Feb 28, 2020

Actual Study Completion Date :

Mar 18, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Daily morphine milligram equivalents of opioid [up to 8 days]
Daily opioid consumption reported as OMED
Total opioid consumption in morphine milligram equivalents [8 day period]
Total opioid consumption for entire 8 days after surgery
Participant reported "worst pain" level on a numeric rating scale after surgery [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.
Overall benefit of anesthesia score (OBAS) [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 Outcome Measures

Change in pain from baseline [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.