Liposomal Bupivacaine vs Dexamethasone ISB

Prolonging the Interscalene Brachial Plexus Block by Adding Liposomal Bupivacaine or Preservative Free Dexamethasone to Bupivacaine: a Non-inferiority Trial

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Pain
• Intervention / Treatment: Drug: Exparel 133 MG Per 10 ML Injection; Drug: Dexamethasone

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital For Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liposomal bupivacaine & standard bupivacaine	Drug: Exparel 133 MG Per 10 ML Injection; 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total); Other Names: Liposomal Bupivacaine
Active Comparator: Standard bupivacaine & dexamethasone	Drug: Dexamethasone; 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale (NRS) Pain at Rest	NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain at rest. Lower score is a better outcome.	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	NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain with movement. Lower score means better outcome.	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	Opioid consumption, measured in oral morphine equivalents	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	Patient reported satisfaction on a scale of 0 (not satisfied) to 10 (complete satisfaction). This is patient opinionated and is reflective with patient contentedness with their pain management. Higher scores indicate greater satisfaction	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	The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. Higher scores indicate more pain. The minimum value is 0, the maximum value is 10. A lower score is a better outcome. This score is an average of the following measures on a 0-10 scale: General activity, Mood, Walking ability, Normal work, Relations to People, Sleep Quality, and Enjoyment of life.	Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7
Duration of Analgesic Block	Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder. Patients are asked "When did your pain relief from the block completely wear off?" This indicates the block duration.	24, 48, 72, 96 (if needed) hours postoperatively
Sensory Resolution	Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder.	24, 48, 72, 96 (if needed) hours postoperatively
Motor Block Resolution	Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder.	24, 48, 72, 96 (if needed) hours postoperatively
Time to Readiness for Discharge	Time to readiness for PACU discharge was evaluated every 15min using the Post Anesthetic Discharge Scoring System.	Postanesthesia care unit (0-6 hours postoperative)
Postanesthesia Care Unit Length of Stay	Total length of PACU stay as defined by time of PACU admission to PACU discharge.	Postanesthesia care unit (0-6 hours postoperative)

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: David Kim, MD, Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2019
• Primary Completion (Actual): March 15, 2021
• Study Completion (Actual): March 19, 2021

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: August 5, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anesthetics, Local; Dexamethasone; Bupivacaine
• Other Study ID Numbers: 2019-0424

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices).
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes