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

NCT03845894 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: IRB00055981
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shoulder Arthroplasty

Keywords

Shoulder Replacement Surgery; Interscalene Nerve Block; Liposomal Bupivacaine; Shoulder pain; Regional anesthesia; Brachial plexus blockade

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Postoperative Opioid Consumption for the First 48 Hours

  up to 48 hours

• Satisfaction With Surgical Experience

  at 48 hours

Study Arms (2)

Liposomal Bupivacaine Interscalene brachial plexus (ISB)

ACTIVE COMPARATOR

Drug: Liposomal bupivacaine

Bupivacaine with adjuvants ISB

ACTIVE COMPARATOR

Drug: Bupivacaine with adjuvants

Interventions

Liposomal bupivacaine DRUG

Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine)

Liposomal Bupivacaine Interscalene brachial plexus (ISB)

Bupivacaine with adjuvants DRUG

Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone.

Bupivacaine with adjuvants ISB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (5)

• 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.

  PMID: 27732710 BACKGROUND

• 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.

  PMID: 28146271 BACKGROUND

• 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.

  PMID: 29787389 BACKGROUND

• 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.

  PMID: 27558150 BACKGROUND

• Rabin T. FDA In Brief: FDA approves new use of Exparel for nerve block pain relief following shoulder surgeries.

  BACKGROUND

MeSH Terms

Conditions

Shoulder Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Jonathan Doug Jaffe DO
• Organization: Wake Forest School of Medicine

jjaffe@wakehealth.edu

336-716-4498

Study Officials

• Doug Jaffe, DO

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: February 19, 2019
• Study Start: March 3, 2020
• Primary Completion: June 25, 2022
• Study Completion: June 25, 2022
• Last Updated: November 13, 2023
• Results First Posted: November 13, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Available after study conclusion, for up to 3 years afterward.

Locations

US (1)