Liposomal Bupivacaine vs Dexamethasone ISB

NCT04047446 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2019-0424
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale (NRS) Pain at Rest Over 72 Hours

  NRS pain at rest averaged over the first 72 hours. NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable). Patient reported pain at 24, 48, and 72 hours are averaged to produce this number. Lower score is a better outcome.

  First 72 hours pain

Secondary Outcomes (10)

• Numerical Rating Scale (NRS) Pain at Rest

  Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7

• Numerical Rating Scale (NRS) Pain With Movement

  Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7

• Opioid Consumption

  Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7

• Patient Satisfaction With Pain Management: Scale

  Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7

• Brief Pain Inventory Short-form

  Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7

Study Arms (2)

Liposomal bupivacaine & standard bupivacaine

EXPERIMENTAL

Drug: Exparel 133 MG Per 10 ML Injection

Standard bupivacaine & dexamethasone

ACTIVE COMPARATOR

Drug: Dexamethasone

Interventions

Exparel 133 MG Per 10 ML Injection DRUG

10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)

Also known as: Liposomal Bupivacaine

Liposomal bupivacaine & standard bupivacaine

Dexamethasone DRUG

15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected

Standard bupivacaine & dexamethasone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Injections; Dexamethasone

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr. David H. Kim
• Organization: Hospital for Special Surgery

kimd@hss.edu

212-606-1036

Study Officials

• David Kim, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: August 6, 2019
• Study Start: July 11, 2019
• Primary Completion: March 15, 2021
• Study Completion: March 19, 2021
• Last Updated: August 1, 2022
• Results First Posted: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

US (1)