NCT02695758

Brief Summary

A non-blinded randomized controlled trial, in which participants undergoing primary reverse or total shoulder arthroplasty are randomly assigned to one of two treatment groups.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P75+ for not_applicable

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

Study Start

First participant enrolled

December 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 1, 2016

Completed
Last Updated

March 1, 2016

Status Verified

February 1, 2016

Enrollment Period

1 year

First QC Date

February 22, 2016

Last Update Submit

February 24, 2016

Conditions

Osteoarthritis: Shoulder

Outcome Measures

Primary Outcomes (1)

  • Morphine and Morphine Equivalent consumption

    24 hours following surgery

Study Arms (2)

interscalene brachial plexus block

ACTIVE COMPARATOR

Direct interscalene nerve block injection via brachial plexus

Procedure: Interscalene brachial plexus block

Bupivacaine extended-release liposome injection

ACTIVE COMPARATOR

Infiltration of local anesthetic/analgesic, Bupivacaine extended-release liposome injection (Exparel) + Diluted in 40cc of Saline into the capsule, subscapularis, deltoid, pectoralis major and subcutaneous tissues.

Procedure: bupivacaine extended-release liposome injection

Interventions

Interscalene brachial plexus blockPROCEDURE
interscalene brachial plexus block
bupivacaine extended-release liposome injectionPROCEDURE
Bupivacaine extended-release liposome injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. All individuals undergoing primary reverse and total shoulder arthroplasty by the shoulder service at Methodist Hospital or Rothman Specialty Hospital.

You may not qualify if:

  • Psychiatric illness as defined by co-morbid diagnosis of bipolar disorder or schizophrenia
  • Revision arthroplasty, arthroplasty for fracture
  • Unable/unwilling to consent for enrollment
  • Unable to complete postoperative pain survey
  • Known adverse drug reaction or allergy to the medications used
  • Chronic pain syndromes (including reflex sympathetic dystrophy, fibromyalgia, chronic diffuse musculoskeletal pain)
  • Patients taking long acting narcotic pain medications (including extended release narcotic pain medications and methadone).
  • Patients under the age of 18 years
  • Patients with history of hepatic disease
  • Pregnant women or women who are breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2016

First Posted

March 1, 2016

Study Start

December 1, 2014

Primary Completion

December 1, 2015

Last Updated

March 1, 2016

Record last verified: 2016-02