NCT01977352

Brief Summary

The purpose of this study is to compare the quality and duration of pain relief after shoulder surgery provided by a single injection of liposomal bupivacaine versus standard bupivacaine when administered as an interscalene brachial plexus block. It is hypothesized that the liposomal bupivacaine formulation will provide more effective pain relief than standard bupivacaine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 6, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

April 2, 2018

Completed
Last Updated

April 2, 2018

Status Verified

March 1, 2018

Enrollment Period

1.1 years

First QC Date

October 30, 2013

Results QC Date

May 10, 2017

Last Update Submit

March 2, 2018

Conditions

Shoulder PainRotator Cuff Tear

Keywords

ExparelLiposomal BupivacaineArthroscopic Shoulder Surgery

Outcome Measures

Primary Outcomes (1)

  • Total Opioid Consumption

    Compare total opioid consumption up to 1 week post operatively between patients receiving bupivacaine 0.25% (20 cc) and liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc) for interscalene brachial plexus block.

    Post op Day 1, post op Day 2, post op day 3, post op 1 week

Secondary Outcomes (6)

  • Quality of Analgesia

    Post op Day 1, post op Day 2, post op day 3, post op 1 week

  • Sensory and Motor Block

    at 20 min and at 1 hour

  • Time to First Pain Medicine

    72 hours

  • Time to Discharge Home

    72 hours

  • Incidence of Postoperative Nausea and Vomiting

    72 hours

  • +1 more secondary outcomes

Study Arms (2)

Bupivacaine 0.25%

ACTIVE COMPARATOR

20 cc of bupivacaine 0.25%

Drug: Liposomal bupivacaine

Liposomal bupivacaine

EXPERIMENTAL

liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)

Drug: Bupivacaine 0.25%

Interventions

Liposomal bupivacaineDRUG

liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)

Also known as: Exparel
Bupivacaine 0.25%
Bupivacaine 0.25%DRUG

20 cc of bupivacaine 0.25%

Also known as: Bupivacaine
Liposomal bupivacaine

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • English speaking adults (age \>17 years) of American Society of Anesthesiologists (ASA) I-III physical class scheduled for elective arthroscopic shoulder surgery will be eligible to participate regardless of race/ethnicity.

You may not qualify if:

  • Subjects will not be eligible for this trial if they report a history of an allergy to a local anesthetic, baseline neurological deficit, a medical condition that would make it difficult to assess sensory distribution or communicate with the staff, a recent history (\< 3 months) of drug or alcohol abuse, concomitant opioid therapy, or a preexisting coagulation disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Luke's Roosevelt Hospital Center

New York, New York, 10025, United States

Location

MeSH Terms

Conditions

Shoulder PainRotator Cuff Injuries

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Dr. Ali Shariat
Organization
Icahn School of Medicine at Mount Sinai
alishariatmd@gmail.com

Study Officials

  • Ali Shariat, MD

    St. Luke's-Roosevelt Hospital Center

    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, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2013

First Posted

November 6, 2013

Study Start

January 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

April 2, 2018

Results First Posted

April 2, 2018

Record last verified: 2018-03

Locations

US(1)