Post-operative Exparel Study Following Rotator Cuff Repair | NCT04047745

Studies
Post-operative Exparel Study Following Rotator Cuff Repair

NCT04047745

Sponsor

Rothman Institute Orthopaedics

Status

Unknown status

Last Update Posted

Aug 7, 2019Actual

Enrollment

132Estimated

Phase

Not Applicable

Conditions

Rotator Cuff Tears

Interventions

Liposomal bupivacaine
Ropivacaine injection

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2019Estimated

Primary Completion Date

Sep 2021Estimated

Completion Date

Sep 2021Estimated

First Submitted Date

Aug 5, 2019

First Submission Date that Met QC Criteria

Aug 6, 2019

First Posted Date

Aug 7, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2019

Last Update Posted Date

Aug 7, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary purpose of this study is to determine if the postoperative oral narcotics consumption in patients receiving liposomal bupivacaine (LB) interscalene brachial plexus nerve block (ISBPB) is different than the narcotics consumption receiving traditional bupivacaine ISBPB for arthroscopic rotator cuff repair analgesia.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

132Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
liposomal bupivacaine	Active Comparator		Drug: Liposomal bupivacaine
ropivacaine	Active Comparator		Drug: Ropivacaine injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Liposomal bupivacaine	Drug	interscalene nerve block administered before surgery using 133 mg liposomal bupivacaine with 10mL 0.5% ropivacaine	liposomal bupivacaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
opioid consumption	postsurgical opioid consumption	surgery through 48 hours post-op

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females aged 18 years or older with a full-thickness rotator cuff tear (confirmed on MRI) undergoing arthroscopic rotator cuff repair surgery.
Anesthesiologists physical status 1, 2, or 3 and normal preoperative motor (Lovett scale: biceps, wrist, thumb) and sensory function.

Exclusion Criteria:

Revision shoulder surgery
History of more than 1 prior surgery performed on the operative shoulder
Concomitant severe glenohumeral arthritis
Concomitant adhesive capsulitis
Worker's compensation claim
Pregnancy
History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics
History of renal or hepatic failure
Chronic neuromuscular deficit affecting the surgical limb.
Uncontrolled psychiatric or neurologic disorder

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Director of Clinical Trials	Contact	267-339-7818		tiffany.morrison@rothmanortho.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rothman Orthopaedics at Egg Harbor Township		Egg Harbor	New Jersey	08234	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000070636	Rotator Cuff Injuries

Ancestor Terms

ID	Term
D012421	Rupture
D014947	Wounds and Injuries
D000070599	Shoulder Injuries
D013708	Tendon Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077212	Ropivacaine

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided