Prospective RCT Comparing Perioperative Pain
Not Applicable
Completed
- Conditions
- Arthroplasty Shoulder
- Interventions
- Drug: Saline
- Registration Number
- NCT03253198
- Lead Sponsor
- Rothman Institute Orthopaedics
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 156
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Preoperative block plus Bupivacaine extended-release liposome Bupivacaine liposome 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) Preoperative block plus saline Saline Preoperative interscalene brachial plexus single-shot block using 25ml of 0.5% Ropivicaine plus postoperative 40cc local infiltration of saline
- Primary Outcome Measures
Name Time Method morphine and morphine equivalent consumption 24 hours post surgery
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rothman Institute
🇺🇸Philadelphia, Pennsylvania, United States