Evaluation of Liposomal Bupivacaine Compared to Usual Care and Its Effects on Pain for Cardiac Surgery

NCT04065919 | Unknown Phase 4 FDA Drug

• 1 other identifier: IIT#2018-137
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of Liposomal Bupivacaine Compared to Usual Care and its Effect on Pain for Cardiac Surgery

Conditions

Cardiothoracic Surgery

Outcome Measures

Primary Outcomes (1)

• 20% change in opioids use

  Record daily narcotic use

  From post operative day of cardiac surgery through length of hospital admission and through study completion, an average of one year.

Secondary Outcomes (6)

• Time to extubation

  Post operative day of surgery through study completion, an average of 1 year

• Time to ICU

  Post operative day of surgery through study completion, an average of 1 year

• Pain Scores on Post op day 2,3 and 4

  Post operative day of cardiac surgery through Post operative Day 4

• Total narcotic use on Post op Day 2,3, and 4

  Day of cardiac surgery to Post op day 4

• Time to Hospital Discharge

  Count the number of days from admission for cardiac surgery to day of hospital discharge through study completion , an average of one year

Study Arms (2)

Exparel

ACTIVE COMPARATOR

administration of liposomal bupivacaine 266mg/20mL+ 40 mL bupivacaine 0.25% bupivacaine .

Drug: Liposomal bupivacaine; Drug: 0.25% Bupivacaine with epinephrine

Standard of Therapy

ACTIVE COMPARATOR

administration of 0.25% bupivacaine with epinephrine at 1cc/kg total dose

Drug: 0.25% Bupivacaine with epinephrine

Interventions

Liposomal bupivacaine DRUG

20mL EXPAREL+40mL bupivacaine 0.25% infiltrated into 5th intercostal space

Also known as: Exparel

Exparel

0.25% Bupivacaine with epinephrine DRUG

0.25% Bupivacaine with epinephrine at 1cc/kg total dose infiltrated into 5th intercostal space

Exparel; Standard of Therapy

Eligibility Criteria

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

You may qualify if:

• Age \>18 years old
• All open heart surgeries from September 1, 2019 - September 30, 2020
• Able to read, comprehend and sign the informed consent form

You may not qualify if:

• Pregnancy
• \< 18 years old and prisoners
• Not able to sign informed consent, including patients with an (LAR) legally authorized representative
• Patients with chronic pain requiring scheduled narcotic use
• Stage 4 kidney disease, Child Pugh score suggestive of liver cirrhosis/ disease
• Recent MI within 7 days of scheduled Cardiac surgery
• Known allergy to Liposomal Bupivacaine or derivative of
• Have or is currently involved in a Research Study within 30 days of scheduled surgery

Sponsors & Collaborators

• Florida Heart and Lung Institute: lead

Study Sites (1)

Florida Heart and Lung Institute

Gainesville, Florida, 32605, United States

Location

MeSH Terms

Interventions

Bupivacaine; Epinephrine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Charles T Klodell, MD

  Florida Heart and Lung Institute, HCA Physician Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients will be randomized per study coordinator. SOC includes 0.25%bupivacaine with epinephrine at 1cc/kg total dose and the treatment arm will include liposomal bupivacaine 266mg/20ml added to usual dose.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiothoracic Surgeon

Model Details: Study comparing current standard of therapy using 0.25% bupivacaine with epinepherine at 1cc/kg total dose and the addition of liposomal bupivacaine 266mg/20ml for pain management in cardiac surgery. Patient and Investigator are blinded.

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 22, 2019
• Study Start: October 1, 2019
• Primary Completion: October 30, 2020
• Study Completion: November 30, 2020
• Last Updated: February 6, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)