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

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ClinicalTrials.gov Identifier: NCT02695758
Recruitment Status : Completed
First Posted : March 1, 2016
Last Update Posted : March 1, 2016
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis: Shoulder Procedure: Interscalene brachial plexus block Procedure: bupivacaine extended-release liposome injection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Local Intraoperative Analgesic Injection Versus Single Injection Interscalene Nerve Block in Patients Undergoing Shoulder Arthroplasty (TSA): A Randomized Trial
Study Start Date : December 2014
Actual Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: interscalene brachial plexus block
Direct interscalene nerve block injection via brachial plexus
Procedure: Interscalene brachial plexus block
Active Comparator: Bupivacaine extended-release liposome injection
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.
Procedure: bupivacaine extended-release liposome injection



Primary Outcome Measures :
  1. Morphine and Morphine Equivalent consumption [ Time Frame: 24 hours following surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT02695758    
Other Study ID Numbers: 2016Nam2
First Posted: March 1, 2016    Key Record Dates
Last Update Posted: March 1, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents