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

Prospective, Randomized Clinical Trial Comparing Analgesic Efficacy of Liposomal Bupivacaine Single-Injection Interscalene Blockade to Continuous Interscalene Blockade for Patients Undergoing Primary Total Shoulder Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Brachial Plexus Block
• Intervention / Treatment: Drug: Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj; Drug: Bupivacaine HCl

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• 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

Exclusion Criteria

• 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)
• Non-English speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: liposomal bupivacaine single-shot interscalene blockade; 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; 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).
Active Comparator: continuous interscalene nerve blockade; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Opioid Consumption	Reported in mg oral morphine equivalents (OME); measured from PACU through postoperative day 3	PACU to postoperative day 3
Quality of Recovery Score (QoR)	15 item short form patient survey using a scoring system evaluating 5 dimensions of health: psychological support, comfort, emotions, physical independence, and pain. The 11-point numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).	Post-Operative Day 1

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Jason K Panchamia, DO, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2021
• Primary Completion (Actual): March 18, 2023
• Study Completion (Actual): March 18, 2023

Study Registration Dates

• First Submitted: August 8, 2021
• First Submitted That Met QC Criteria: August 8, 2021
• First Posted (Actual): August 13, 2021

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: pain management; QoR-15; total shoulder arthroplasty; Interscalene nerve block; OBAS
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 21-000908

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No