Status:
COMPLETED
Interscalene Bupivacaine With Either Liposomal Bupivacaine or Continuous Peripheral Nerve Block for Shoulder Arthroscopy
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Shoulder Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This investigation will be a prospective, randomized trial. The study population will consist of adult patients scheduled to undergo major shoulder arthroscopy procedures with anesthesiology at the Am...
Detailed Description
Once potential candidates are identified, charts will be reviewed for initial data collection and to determine if the patient meets inclusion criteria and is free of exclusion criteria. Eligible indiv...
Eligibility Criteria
Inclusion
- Adult patients ≥ 18 years
- Individuals presenting for major shoulder arthroscopy procedures at Ambulatory Services Center (Outpatient Surgery Center) -that include rotator cuff repair and biceps tenodesis
- Patient is able to provide informed consent to participate in the study.
Exclusion
- Allergy to amide local anesthetic, liposomal bupivacaine or other medication involving liposomal formulation
- Preexisting neurological deficits involving or potentially involving the ipsilateral brachial plexus
- Preexisting contralateral vocal fold paralysis or recurrent laryngeal paralysis
- Psychiatric or cognitive disorders that could interfere with perioperative evaluation including drug or alcohol abuse
- Chronic pain conditions
- Preoperative opioid consumption greater than 20 mg oral morphine equivalent.
- Any contraindication to interscalene nerve block including any local disorder of the skin where blockade is to be performed which would prevent safe performance of the block
- Any coagulation abnormality which would be a contraindication for block placement
- Preoperative chronic renal dysfunction requiring renal replacement therapy or a serum creatinine greater than 1.4 mg/dL
- Body mass index \>50
- Pregnancy
- Incarceration
- ASA classification greater than 3
- Inability to provide informed consent
Key Trial Info
Start Date :
October 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03816982
Start Date
October 11 2019
End Date
December 30 2022
Last Update
August 23 2023
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390