Clinical trial NCT04047446: Liposomal Bupivacaine vs Dexamethasone ISB
Official title: Prolonging the Interscalene Brachial Plexus Block by Adding Liposomal Bupivacaine or Preservative Free Dexamethasone to Bupivacaine: a Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Shoulder Pain
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, patients receiving shoulder arthroscopy will receive an interscalene block for pain management containing either liposomal bupivacaine and standard bupivacaine or standard bupivacaine and dexamethasone. Patients will be followed up with to determine postoperative pain and block duration.


Eligibility criteria: Inclusion Criteria:

* ASA I-III
* Age 18 years or older
* Scheduled for elective outpatient arthroscopic shoulder surgery

Exclusion Criteria:

* History of allergy to local anesthetic, or one of the study medications
* Pre-existing neurological deficits
* Psychiatric or cognitive disorders that prohibit patients from following study protocol
* History of drug or alcohol abuse
* Chronic opioid use (longer than 3 months)
* Chronic pain syndromes
* Infection at the site of injection
* Patients with severe pulmonary disease
* Herniated cervical disc, cervical myelopathy
* Contraindication for general anesthesia and/or interscalene nerve block
* Pregnancy
* Open shoulder arthrotomies.
* Non English speakers

Primary outcomes:
measure: Numerical Rating Scale (NRS) Pain at Rest Over 72 Hours
timeFrame: First 72 hours pain
Secondary outcomes:
measure: Numerical Rating Scale (NRS) Pain at Rest
timeFrame: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7
measure: Numerical Rating Scale (NRS) Pain With Movement
timeFrame: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7
measure: Opioid Consumption
timeFrame: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7
measure: Patient Satisfaction With Pain Management: Scale
timeFrame: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7
measure: Brief Pain Inventory Short-form
timeFrame: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7
measure: Duration of Analgesic Block
timeFrame: 24, 48, 72, 96 (if needed) hours postoperatively
measure: Sensory Resolution
timeFrame: 24, 48, 72, 96 (if needed) hours postoperatively
measure: Motor Block Resolution
timeFrame: 24, 48, 72, 96 (if needed) hours postoperatively
measure: Time to Readiness for Discharge
timeFrame: Postanesthesia care unit (0-6 hours postoperative)
measure: Postanesthesia Care Unit Length of Stay
timeFrame: Postanesthesia care unit (0-6 hours postoperative)
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: David Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: