Status:

COMPLETED

Prospective RCT Comparing Perioperative Pain

Lead Sponsor:

Rothman Institute Orthopaedics

Conditions:

Arthroplasty Shoulder

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

This study is a non-blinded randomized controlled trial comparing the use of a preoperative "mini" block plus postoperative local infiltration of Exparel (liposomal form of bupivacaine) versus a parti...

Eligibility Criteria

Inclusion

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

Exclusion

  • Psychiatric illness as defined by co-morbid diagnosis of bipolar disorder or schizophrenia
  • Revision arthroplasty or 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 opioid pain medications (including extended release opioid pain medications and methadone)
  • Patients under the age of 18 years
  • Patients with history of hepatic disease
  • Pregnant or breastfeeding women.

Key Trial Info

Start Date :

August 1 2016

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2017

Estimated Enrollment :

156 Patients enrolled

Trial Details

Trial ID

NCT03253198

Start Date

August 1 2016

End Date

July 1 2017

Last Update

May 22 2018

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Rothman Institute

Philadelphia, Pennsylvania, United States, 19107