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

Shoulder Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04737980
• Other study ID #: JMC0023RSOP
• Status: Completed
• Phase: Phase 4
• Start date: July 18, 2019
• Est. completion date: March 18, 2020

Study information

• Verified date: February 2021
• Source: Hospital for Special Surgery Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: March 18, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears
• Shoulder Pain

Intervention

Drug:
• Liposomal bupivacaine
Injection of 10 ml of liposomal bupivacaine 1.3% (133 mg) for ultrasound guided interscalene block
• Bupivacaine Hcl 0.5% Inj
Injection of 10 ml of 0.5% bupivacaine hydrochloride as admixture for ultrasound guided interscalene block
• Ropivacaine 0.5% Injectable Solution
Injection of 30 ml of ropivacaine 0.5% injectable solution for ultrasound guided interscalene block
• Dexamethasone
Injection of 8mg (2ml) dexamethasone injectable as admixture

Locations

Country	Name	City	State
United States	HSS Florida	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery Florida

Country where clinical trial is conducted

United States, 

References & Publications (9)

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):1114-29. doi: 10.1213/ANE.0000000000000688. Review. — View 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. 2020 Dec 28. doi: 10.1097/ALN.0000000000003651. — View 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.2019.0 — View 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 — View 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/J — View 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-B — View 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. Review. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily morphine milligram equivalents of opioid	Daily opioid consumption reported as OMED	up to 8 days
Primary	Total opioid consumption in morphine milligram equivalents	Total opioid consumption for entire 8 days after surgery	8 day period
Primary	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
Primary	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	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