Prospective RCT Comparing Perioperative Pain

Arthroplasty Shoulder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03253198
• Other study ID #: 2017SNam
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: July 2017

Study information

• Verified date: May 2018
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty Shoulder

Intervention

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

Locations

Country	Name	City	State
United States	Rothman Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morphine and morphine equivalent consumption		24 hours post surgery