Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine Hydrochloride

NCT03270514 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: PRO17060305
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the analgesic efficacy and safety of wound infiltration with liposomal bupivacaine (LB) in patients undergoing cardiac surgery with sternotomy and cardiopulmonary bypass (CPB) and compare it with bupivacaine hydrochloride infiltration

Conditions

Coronary Artery Disease; Coronary Artery Stenoses; Valve Regurgitation, Mitral; Valve Regurgitation, Tricuspid

Keywords

cardiac surgery; sternotomy; post-operative pain; sternal wound infiltration

Outcome Measures

Primary Outcomes (2)

• Post-operative Pain Intensity

  Postoperative pain scores evaluated by numeric rating scale or (NRS) where 0- no pain and 10- worst pain, at rest and at movement

  NRS scores will be evaluated every 4 hours until 24 hours post-operatively, every 8 hours until 48 hours post-operatively, and every 12 hours for 72 hours post-operatively

• Total Narcotic Consumption

  All narcotics administered in the first 0-8, 8-24, 24-48, and 48-72 hours and the total narcotics administered in the 0-72 hours postoperative period(PCA narcotics, nurse-administered IV narcotics, and oral narcotics). All narcotics will be converted to total IV morphine equivalent for comparison between two groups.

  0-72 hours post-operative period

Secondary Outcomes (12)

• Time to Extubation

  From the end of surgery until the patient is extubated up to 72 hours post-operatively

• Patient Time to Mobilization

  From time of end of surgery to time of mobilization up to 72 hours or discharge, *assessed up to 120 hours*

• Patient Time to Out of Bed to Chair

  From time of end of surgery to time of mobilization up to 72 hours post-operatively

• Patient Time to Oral Intake

  From time of end of surgery to time of oral intake up to 72 hours post-operatively or until hospital discharge

• Non-invasive Ventilation (NIV) Requirement

  From time of end of surgery to 72 hours post-operatively or until hospital discharge

Other Outcomes (6)

• Delirium

  Assessment will be administered at 48 hours post-operatively

• Delirium

  Assessment will be administered at 72 hours post-operatively

• Patient Satisfaction

  Given at the time of discharge up to 30 days post-operatively

Study Arms (2)

Exparel Injectable Product

EXPERIMENTAL

Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30).

Drug: Exparel Injectable Product

Bupivacaine Hydrochloride

ACTIVE COMPARATOR

Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).

Drug: Bupivacaine Hydrochloride

Interventions

Exparel Injectable Product DRUG

Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)

Also known as: Liposomal Bupivacaine

Exparel Injectable Product

Bupivacaine Hydrochloride DRUG

Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)

Also known as: Bupivacaine

Bupivacaine Hydrochloride

Eligibility Criteria

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

You may qualify if:

• Open cardiac surgery through sternotomy approach (eg. coronary artery bypass graft, valvular heart procedures, as well as other open cardiac procedures along with coronary artery bypass)
• Surgery with the use of cardiopulmonary bypass

You may not qualify if:

• Minimally invasive heart surgery through thoracotomy approach
• Patient undergoing procedures under deep hypothermic circulatory arrest
• Patients with active infections such as infective endocarditis
• Emergency surgery
• Patients undergoing transplantations and ventricular assist device insertion
• Patients on any mechanical circulatory support preoperatively
• Patient's refusal
• End stage liver or renal disease
• Allergy to bupivacaine
• Patient who cannot understand the study procedure or refuse to participate
• Redo-sternotomy
• Participation in another study
• Patients with severe right or left ventricular dysfunction (EF\< 25%)
• Patients requiring chronic opioids for chronic pain condition

Sponsors & Collaborators

• Kathirvel Subramaniam: lead
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (1)

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (28)

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MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis; Mitral Valve Insufficiency; Tricuspid Valve Insufficiency; Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Heart Valve Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Kathirvel Subramaniam, MD, MPH, FASE
• Organization: University of Pittsburgh Medical Center Department of Anesthesiology and Perioperative Medicine

subramaniamk@upmc.edu

724-799-5852

Study Officials

• Kathirvel Subramaniam, MD, MPH

  Associate Professor and staff Anesthesiologist

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care provider, investigator, and outcomes assessor are all blinded to the treatment allocation in double-blind fashion
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Associate Professor

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: September 1, 2017
• Study Start: November 15, 2018
• Primary Completion: December 13, 2019
• Study Completion: February 25, 2020
• Last Updated: September 5, 2021
• Results First Posted: September 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)