Interscalene Block With Liposomal Bupivacaine vs. Interscalene Block With Bupivacaine and Adjuvants

Single Injection Interscalene Brachial Plexus Nerve Block With Adjuvants vs. Liposomal Bupivacaine Interscalene Brachial Plexus Nerve Block for Total Shoulder Arthroplasty

The purpose of this study is to determine whether the use of plain bupivacaine with common adjuvants for interscalene block (ISB) provides non-inferior analgesic results compared to the use of liposomal bupivacaine for ISB, in patients undergoing total shoulder arthroplasty.

Study Overview

• Status: Terminated
• Conditions: Shoulder Arthroplasty
• Intervention / Treatment: Drug: Liposomal bupivacaine; Drug: Bupivacaine with adjuvants

Detailed Description

The primary objective of this clinical study is to evaluate the comparative efficacy of interscalene block (ISB) using plain bupivacaine with adjuvants vs. liposomal bupivacaine on mean postoperative pain levels in patients who have undergone a total shoulder arthroplasty within the first 48 hours. Principal Investigators hypothesize that ISB using plain bupivacaine with adjuvants will provide similar pain relief as ISB using liposomal bupivacaine.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All patients undergoing total shoulder arthroplasty (not a reverse)
• Age ≥ 18 years
• Ability to understand and the willingness to sign an IRB-approved informed consent document.
• ASA patient status I-III patients
• Weight Greater than or equal to 50 kg

Exclusion Criteria:

• Contraindications to an interscalene block or phrenic blockade
• Infection at injection site
• Pre-existing neurological dysfunction affecting the operative extremity
• Chronic pain diagnosis or opioid use >40mg oxycodone daily equivalents or use of long-acting opioids
• BMI >40
• Uncontrolled diabetes (A1c >8.0)
• Concurrent painful physical condition requiring analgesic treatment (eg, NSAID or opioid) in the postsurgical period for pain not strictly related to the surgery
• Contraindications to any pain-control agents planned for surgical or postsurgical use (i.e., bupivacaine, hydromorphone, etc.)
• Patients who are wards of the state
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to bupivacaine or liposomal bupivacaine.
• Patients with moderate-severe hepatic or renal impairment

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bupivacaine with adjuvants ISB	Drug: Bupivacaine with adjuvants; Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone.
Active Comparator: Liposomal Bupivacaine Interscalene brachial plexus (ISB)	Drug: Liposomal bupivacaine; Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Pain Scores for the First 48 Hours	Pain levels will be measured by the mean Visual Analogue Scale- Numeric Rating Scale (VAS-NRS). The VAS-NRS is an 11 point scale with 0 (no pain) to 10 (worst possible pain). Higher scores denote worse outcome.	At 48 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Opioid Consumption for the First 48 Hours	Morphine milligram equivalents (MME) over a 48 hour period	up to 48 hours
Satisfaction With Surgical Experience	Satisfaction scale is from 1-5, with the higher score being highest level of satisfaction	at 48 hours

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Doug Jaffe, DO, Wake Forest University Health Sciences

Publications and helpful links

General Publications

• Sakamoto B, Keiser S, Meldrum R, Harker G, Freese A. Efficacy of Liposomal Bupivacaine Infiltration on the Management of Total Knee Arthroplasty. JAMA Surg. 2017 Jan 1;152(1):90-95. doi: 10.1001/jamasurg.2016.3474.
• Hamilton TW, Athanassoglou V, Mellon S, Strickland LH, Trivella M, Murray D, Pandit HG. Liposomal bupivacaine infiltration at the surgical site for the management of postoperative pain. Cochrane Database Syst Rev. 2017 Feb 1;2(2):CD011419. doi: 10.1002/14651858.CD011419.pub2.
• Pichler L, Poeran J, Zubizarreta N, Cozowicz C, Sun EC, Mazumdar M, Memtsoudis SG. Liposomal Bupivacaine Does Not Reduce Inpatient Opioid Prescription or Related Complications after Knee Arthroplasty: A Database Analysis. Anesthesiology. 2018 Oct;129(4):689-699. doi: 10.1097/ALN.0000000000002267.
• Hamilton TW, Athanassoglou V, Trivella M, Strickland LH, Mellon S, Murray D, Pandit HG. Liposomal bupivacaine peripheral nerve block for the management of postoperative pain. Cochrane Database Syst Rev. 2016 Aug 25;2016(8):CD011476. doi: 10.1002/14651858.CD011476.pub2.
• Rabin T. FDA In Brief: FDA approves new use of Exparel for nerve block pain relief following shoulder surgeries.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2020
• Primary Completion (Actual): June 25, 2022
• Study Completion (Actual): June 25, 2022

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Actual): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Liposomal Bupivacaine; Regional anesthesia; Shoulder pain; Interscalene Nerve Block; Brachial plexus blockade; Shoulder Replacement Surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: IRB00055981

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will be shared upon request: raw data and statistical calculations
• IPD Sharing Time Frame: Available after study conclusion, for up to 3 years afterward.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

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