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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05005260
Other study ID # 21-000908
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 14, 2021
Est. completion date March 18, 2023

Study information

Verified date April 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date March 18, 2023
Est. primary completion date March 18, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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).

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Cumulative Opioid Consumption Reported in mg oral morphine equivalents (OME); measured from PACU through postoperative day 3 PACU to postoperative day 3
Secondary 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
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