Local Intraoperative Analgesic Injection Versus Single Injection Interscalene Nerve Block in Patients Undergoing TSA

R

Rothman Institute Orthopaedics

Status

Completed

Conditions

Osteoarthritis: Shoulder

Treatments

Procedure: bupivacaine extended-release liposome injection
Procedure: Interscalene brachial plexus block

Study type

Interventional

Funder types

Other

Identifiers

NCT02695758
2016Nam2

Details and patient eligibility

About

A non-blinded randomized controlled trial, in which participants undergoing primary reverse or total shoulder arthroplasty are randomly assigned to one of two treatment groups.

Enrollment

156 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. All individuals undergoing primary reverse and total shoulder arthroplasty by the shoulder service at Methodist Hospital or Rothman Specialty Hospital.

Exclusion criteria

  1. Psychiatric illness as defined by co-morbid diagnosis of bipolar disorder or schizophrenia
  2. Revision arthroplasty, arthroplasty for fracture
  3. Unable/unwilling to consent for enrollment
  4. Unable to complete postoperative pain survey
  5. Known adverse drug reaction or allergy to the medications used
  6. Chronic pain syndromes (including reflex sympathetic dystrophy, fibromyalgia, chronic diffuse musculoskeletal pain)
  7. Patients taking long acting narcotic pain medications (including extended release narcotic pain medications and methadone).
  8. Patients under the age of 18 years
  9. Patients with history of hepatic disease
  10. Pregnant women or women who are breastfeeding

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

156 participants in 2 patient groups

interscalene brachial plexus block
Active Comparator group
Description:
Direct interscalene nerve block injection via brachial plexus
Treatment:
Procedure: Interscalene brachial plexus block
Bupivacaine extended-release liposome injection
Active Comparator group
Description:
Infiltration of local anesthetic/analgesic, Bupivacaine extended-release liposome injection (Exparel) + Diluted in 40cc of Saline into the capsule, subscapularis, deltoid, pectoralis major and subcutaneous tissues.
Treatment:
Procedure: bupivacaine extended-release liposome injection

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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