Prospective RCT Comparing Perioperative Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Arthroplasty Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Preoperative block plus saline

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

Group Type ACTIVE_COMPARATOR

Saline

Intervention Type DRUG

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

Preoperative block plus Bupivacaine extended-release 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)

Group Type ACTIVE_COMPARATOR

Bupivacaine liposome

Intervention Type DRUG

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)

Interventions

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Saline

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

Intervention Type DRUG

Bupivacaine liposome

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)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No