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)
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1
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107