Prospective RCT Comparing Perioperative Pain

Preoperative Interscalene Nerve Block Plus Postoperative Local Intra-operative Analgesic Injection vs Preoperative Interscalene Nerve Block Plus Postoperative Saline Injection in Patients Undergoing Shoulder Arthroplasty: a Randomized Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03253198

Enrollment

156

Registered

2017-08-17

Start date

2016-08-31

Completion date

2017-07-31

Last updated

2018-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty Shoulder

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.

Interventions

DRUGSaline

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

DRUGBupivacaine 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
morphine and morphine equivalent consumption	24 hours post surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026