Single Shot Liposomal Bupivicaine in Rotator Cuff Surgery

NCT03822182 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 1806933448
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This document is a protocol for a human research study. This study is to be conducted according to United States standards of Good Clinical Practice in accordance with applicable Federal regulations and institutional research policies and procedures. Liposomal bupivacaine (LB) has been shown to decrease post-operative pain and narcotic use when administered perioperatively as a local injection during arthroplasty procedures. Studies have also demonstrated that LB used in conjunction with dexamethasone may increase the duration of effectiveness of LB. This study seeks to evaluate if there is a difference in post-operative pain and narcotic use when LB is administered in an interscalene block during outpatient rotator cuff repair surgery. Furthermore, this study aims to determine if the addition of dexamethasone with LB results in a prolonged decrease in post-operative pain and a reduction in narcotic use.

Conditions

Rotator Cuff Tear; Pain, Postoperative

Keywords

liposomal bupivicaine; interscalene block

Outcome Measures

Primary Outcomes (1)

• Patient Reported Postoperative Pain: VAS

  Patient-reported post-operative VAS pain (on a scale of 0-10 with zero implying no pain and 10 indicating severe pain), measured post operatively, in 8-hour increments, for a total of 96 hours post-surgery, Patients will be prompted via text message to provide VAS pain every 8 hours. If a response text message is not received, a phone call will be made to obtain the information. Patients who do not have a smart phone will receive a phone call or keep a personal log of VAS pain.

  4 days post procedure

Secondary Outcomes (1)

• Patient Reported Post Operative Opioid Use

  4 days post procedure

Study Arms (3)

Control/Bupivicaine +DMSO

OTHER

Group 1 will serve as the control and receive the standard injection consisting 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone.

Drug: Dexamethasone

Liposomal bupivicaine

ACTIVE COMPARATOR

Group 2 will receive a block with 15ml 0.5% bupivacaine and 10ml (133mg) of liposomal bupivicaine (Exparel) and 5.4ml of Normal Saline

Drug: liposomal bupivicaine

Liposomal Bupivicaine +DMSO

ACTIVE COMPARATOR

Group 3 will receive 15ml of 0.5% bupivicaine and 10ml (133mg) of Liposomal Bupivicaine (Exparel) and 0.4ml (4mg) dexamethasone and 5ml normal saline

Drug: liposomal bupivicaine; Drug: Dexamethasone

Interventions

liposomal bupivicaine DRUG

The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below: Group 1 (Control): 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone Group 2: 15ml 0.5% bupivacaine and 10ml (133mg) of LB (Exparel) and 5.4ml normal saline Group 3: 5ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml (4 mg) dexamethasone and 5ml normal saline

Also known as: Exparel

Liposomal Bupivicaine +DMSO; Liposomal bupivicaine

Dexamethasone DRUG

steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine.

Control/Bupivicaine +DMSO; Liposomal Bupivicaine +DMSO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and older
• Primary diagnosis of rotator cuff tear
• Able to provide informed consent
• Is willing and able to accept text messages

You may not qualify if:

• Known allergies to the study medications.
• Known narcotic or alcohol abuse (\< 3 months)
• Revision rotator cuff surgery
• Contraindication to regional anesthesia
• Current narcotic regimen or contract with pain management specialist
• Diagnosed with any of the following co-morbidities:
• Pre-existing coagulation disorder

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

American Health Network

Avon, Indiana, 46123, United States

Location

Related Publications (3)

• Cao X, Pan F. Comparison of liposomal bupivacaine infiltration versus interscalene nerve block for pain control in total shoulder arthroplasty: A meta-analysis of randomized control trails. Medicine (Baltimore). 2017 Sep;96(39):e8079. doi: 10.1097/MD.0000000000008079.

  PMID: 28953626 BACKGROUND

• Bramlett K, Onel E, Viscusi ER, Jones K. A randomized, double-blind, dose-ranging study comparing wound infiltration of DepoFoam bupivacaine, an extended-release liposomal bupivacaine, to bupivacaine HCl for postsurgical analgesia in total knee arthroplasty. Knee. 2012 Oct;19(5):530-6. doi: 10.1016/j.knee.2011.12.004. Epub 2012 Jan 28.

  PMID: 22285545 BACKGROUND

• Surdam JW, Licini DJ, Baynes NT, Arce BR. The use of exparel (liposomal bupivacaine) to manage postoperative pain in unilateral total knee arthroplasty patients. J Arthroplasty. 2015 Feb;30(2):325-9. doi: 10.1016/j.arth.2014.09.004. Epub 2014 Sep 16.

  PMID: 25282071 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries; Pain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Brian Badman
• Organization: AHNI Orthopedics

bbadman@gmail.com

3178328800

Study Officials

• brian badman, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This is a double-blinded study, thus, neither the surgeon nor the patient will know which type of interscalene block is used. A total of 78 envelopes containing will be generated consisting of 26 with Group 1", 26 with "Group 2" and 26 with "Group 3" designation. Envelopes will be sealed and randomly chosen by the anesthesiologist prior to surgery. The anesthesiologist will randomly select one of the envelopes which will determine the treatment group and indicate medications that will be included in the interscalene block. Patients will be blinded to the medication utilized as well as the treating surgeon.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Associate Professor, Department of Orthopedic Surgery

Model Details: The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below: Group 1 (Control) Group 2 Group 3 30 ml of 0.5% bupivacaine and 0.4ml. of dexamethasone 15ml 0.5% bupivacaine and 10ml of LB (Exparel) and 5.4ml normal saline 15ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml dexamethasone and 5ml normal saline

Study Record Dates

• First Submitted: January 27, 2019
• First Posted: January 30, 2019
• Study Start: October 24, 2018
• Primary Completion: January 22, 2020
• Study Completion: January 22, 2020
• Last Updated: November 12, 2020
• Results First Posted: September 1, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)