Prospective RCT Comparing Perioperative Pain

Completed · Not applicable

Conditions studied: Arthroplasty Shoulder

In brief

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 partial single shot nerve block in subjects undergoing primary reverse or total shoulder arthroplasty to see which is more effective in controlling surgery related pain. To do so, we will utilize the Visual Analog Scale (VAS) to measure pain intensity. Opioid consumption will be recorded on a Pain Monitoring Sheet.

Key facts

Study ID: NCT03253198
Run by: Rothman Institute Orthopaedics
People needed: 156
Starts: 2016-08-01
Expected to finish: 2017-07-01
Last updated by the study team: 2018-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

All individuals undergoing primary reverse and total shoulder arthroplasty by the shoulder service at Thomas Jefferson University Hospital, 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 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.

Where it is running

Rothman Institute — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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