Liposomal Bupivacaine Single-Injection Interscalene Block vs. Continuous Interscalene Block for Primary Total Shoulder Arthroplasty

NCT05005260 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 21-000908
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess analgesia efficacy between liposomal bupivacaine single injection interscalene blockade vs. continuous interscalene nerve block for patients undergoing primary total shoulder arthroplasty.

Conditions

Pain, Postoperative; Brachial Plexus Block

Keywords

Interscalene nerve block; total shoulder arthroplasty; pain management; OBAS; QoR-15

Outcome Measures

Primary Outcomes (1)

• Pain Intensity Score at Rest at 24 Hours Post-operatively

  Self-reported pain intensity scores measure using numerical rating scale of 0 (no pain) to 10 (worst pain imaginable). Primary outcome was measured at 24 hours postoperative time point.

  Post-Operative Day 1

Secondary Outcomes (2)

• Cumulative Opioid Consumption

  PACU to postoperative day 3

• Quality of Recovery Score (QoR)

  Post-Operative Day 1

Study Arms (2)

liposomal bupivacaine single-shot interscalene blockade

ACTIVE COMPARATOR

Subjects will receive a preoperative single-injection interscalene nerve block with long-acting numbing medicine, liposomal bupivacaine

Drug: Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj

continuous interscalene nerve blockade

ACTIVE COMPARATOR

Subjects will receive a preoperative interscalene nerve block with a continuous catheter device which provides local anesthetic, bupivacaine, for up to 3 days.

Drug: Bupivacaine HCl

Interventions

Bupivacaine HCl DRUG

Subjects randomized to the continuous interscalene nerve block group will receive a loading dose of 15-20 mL bupivacaine HCl 0.5% followed by a continuous catheter infusion of bupivacaine 0.2% at 8 mL per hour for 72 hours.

continuous interscalene nerve blockade

Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj DRUG

Subjects will receive a one-time interscalene nerve block injection of 5 mL of bupivacaine 0.5% (25 mg) admixed with 10 mL of liposomal bupivacaine (133 mg).

liposomal bupivacaine single-shot interscalene blockade

Eligibility Criteria

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

You may qualify if:

• Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
• Patients presenting for unilateral primary total shoulder arthroplasty (includes anatomic and reverse total shoulder arthroplasty).
• Patients 18 years of age and older
• Able to provide informed consent for him or herself

You may not qualify if:

• Chronic pain syndromes
• Chronic opioid use (\>1 month) with OME \>5 mg/day OR acute opioid use (\< 1 month) with OME \> 30 mg/day.
• Body mass index (BMI) \> 45 kg/m2
• Severe drug allergy\* to medications used in this study, including non-steroidal anti-inflammatory drugs (i.e. celecoxib) and local anesthetics. \*defined as an immune reaction resulting in shortness of breath, hives, anaphylaxis, wheezing, and fever
• Personal or family history of malignant hyperthermia.
• Major systemic medical problems such as:
• Pre-existing severe renal disorder defined as glomerular filtration rate (GFR) \<50 units/m2 (if labs are available), currently on dialysis, or highly suspected based on history.
• Severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis of liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver
• Pre-existing medical history of moderate to severe pulmonary disease requiring medical therapy (obstructive and/or restrictive), use of home oxygen, preoperative baseline oxygen saturation \< 93% on room air.
• History of contralateral hemidiaphragm dysfunction (e.g., paralysis) or phrenic nerve injury.
• Contraindication to a regional anesthesia technique (e.g., preexisting neuropathy+ in the operative extremity, coagulopathy, sepsis, infection at site of injection, uncooperative, and refusal).
• o + pre-existing neuropathy includes sensory and/or motor deficits due to nerve insult of surgical extremity, radicular symptoms of surgical extremity, history of unresolved brachial plexus injury/brachial plexopathy, and tumors of the brachial plexus. Patients with nerve compression distal to site of surgery, such as history of carpal tunnel syndrome or cubital tunnel syndrome, are NOT considered contraindications to regional anesthesia.
• Known to be currently pregnant or actively breastfeeding++
• o ++ All surgical patients are currently screened using a standardized Pregnancy Assessment tool (http://mayoweb.mayo.edu/sp-forms/mc8800-mc8899/mc8801-161.pdf)
• Impaired cognition (e.g. Alzheimer's disease, moderate to severe dementia, encephalopathy)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Johar Paul
• Organization: Mayo Clinic

Paul.Johar@mayo.edu

5072556804

Study Officials

• Jason K Panchamia, DO

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Unblinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2021
• First Posted: August 13, 2021
• Study Start: October 14, 2021
• Primary Completion: March 18, 2023
• Study Completion: March 18, 2023
• Last Updated: May 7, 2024
• Results First Posted: December 18, 2023

Record last verified: 2024-04

Locations

US (1)