Prospective RCT Comparing Perioperative Pain

Rothman Institute Orthopaedics156 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

156

Conditions

Arthroplasty Shoulder

Interventions

SalineDRUG

A preoperative interscalene brachial plexus single-shot block using 25 ml of 0.5% Ropivicaine plus saline injection postoperative

Bupivacaine liposomeDRUG

an 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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Rothman Institute

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

morphine and morphine equivalent consumption

Time frame: 24 hours post surgery

Data from ClinicalTrials.gov

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