Prospective RCT Comparing Perioperative Pain

Rothman Institute Orthopaedics

Status: Completed

Conditions: Arthroplasty Shoulder

Treatments: Drug: Saline; Drug: Bupivacaine liposome

Study type: Interventional

Funder types: Other

Identifiers

NCT03253198

2017SNam

Details and patient eligibility

About

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.

Enrollment: 156 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 2 patient groups

Preoperative block plus saline

Active Comparator group

Description:

Preoperative interscalene brachial plexus single-shot block using 25ml of 0.5% Ropivicaine plus postoperative 40cc local infiltration of saline

Treatment:

Drug: Saline

Preoperative block plus Bupivacaine extended-release liposome

Active Comparator group

Description:

Interscalene brachial plexus single shot block preoperatively (25 ml of 0.5% ropivicaine) + Postoperative Infiltration of local anesthetic/analgesic (20 cc Bupivacaine extended-release liposome injection (Exparel) + Diluted in 20cc of Saline into the capsule, subscapularis, deltoid, pectoralis major and subcutaneous tissues)

Treatment:

Drug: Bupivacaine liposome