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

Primary Purpose

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

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Exparel Injectable Product

Bupivacaine Hydrochloride

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring cardiac surgery, sternotomy, post-operative pain, sternal wound infiltration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

UPMC Presbyterian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exparel Injectable Product

Bupivacaine Hydrochloride

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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

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.

Secondary Outcome Measures

Time to Extubation

The time it takes until the patient is extubated post-operatively will be measured

Patient Time to Mobilization

The time it takes until patient ambulates will be measured

Patient Time to Out of Bed to Chair

The time it takes until the patient advances from bedrest to out of bed (OOB) to chair will be measured

Patient Time to Oral Intake

The time it takes until the patient is able to/medically cleared to consume food or liquid will be measured

Non-invasive Ventilation (NIV) Requirement

Episodes of NIV such as upper airway masks or similar devices will be quantified

Re-intubation

Instances of re-intubation will be recorded

Use of Incentive Spirometry

Frequency of incentive spirometry will be measured

Post-operative Nausea and Vomiting

Whether a patient experiences at least one episode of nausea and emesis will be measured

Major Organ Dysfunction

Organ systems such as cardiac, renal, respiratory, and nervous system failure/dysfunction in accordance with the Society of Thoracic Surgeon's database will be noted

Length of Hospital and ICU Stay

Length of both hospital and ICU stay will be measured

Hospital Readmission

Readmission to hospital will be noted

Mortality

Mortality will be noted at specific timepoints

Full Information

NCT ID

NCT03270514

First Posted

August 10, 2017

Last Updated

August 10, 2021

Sponsor

Kathirvel Subramaniam

Collaborators

Pacira Pharmaceuticals, Inc

1. Study Identification

Unique Protocol Identification Number

NCT03270514

Brief Title

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

Official Title

Postoperative Analgesia After Cardiac Surgery - A Double-Blind, Prospective and Randomized Comparison of Wound Infiltration With Liposomal Bupivacaine and Bupivacaine Hydrochloride

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

November 15, 2018 (Actual)

Primary Completion Date

December 13, 2019 (Actual)

Study Completion Date

February 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Kathirvel Subramaniam

Collaborators

Pacira Pharmaceuticals, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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

Detailed Description

There are no studies to date on the use of LB infiltration and its analgesic efficacy in cardiac surgery done through sternotomy, even though the majority of cardiac surgeries utilize this approach. Moderate to severe pain is common in patients undergoing these surgeries and is usually inadequately treated. Other various pain treatment modalities such as opioid and neuraxial anesthesia are avoided due to potentially dangerous side effects in this cohort. The efficacy of local anesthesia techniques, such as bupivacaine, are limited due to short duration of action and increased incidence of wound infection. On the other hand, slow release liposomal bupivacaine may last up to 72 hours, indicating it's potential for more adequate analgesia compared to bupivacaine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Participants, care provider, investigator, and outcomes assessor are all blinded to the treatment allocation in double-blind fashion

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exparel Injectable Product

Arm Type

Experimental

Arm Description

Arm Title

Bupivacaine Hydrochloride

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Exparel Injectable Product

Other Intervention Name(s)

Liposomal Bupivacaine

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Bupivacaine Hydrochloride

Other Intervention Name(s)

Bupivacaine

Intervention Description

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)

Primary Outcome Measure Information:

Title

Post-operative Pain Intensity

Description

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

Time Frame

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

Title

Total Narcotic Consumption

Description

Time Frame

0-72 hours post-operative period

Secondary Outcome Measure Information:

Title

Time to Extubation

Description

The time it takes until the patient is extubated post-operatively will be measured

Time Frame

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

Title

Patient Time to Mobilization

Description

The time it takes until patient ambulates will be measured

Time Frame

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

Title

Patient Time to Out of Bed to Chair

Description

The time it takes until the patient advances from bedrest to out of bed (OOB) to chair will be measured

Time Frame

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

Title

Patient Time to Oral Intake

Description

The time it takes until the patient is able to/medically cleared to consume food or liquid will be measured

Time Frame

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

Title

Non-invasive Ventilation (NIV) Requirement

Description

Episodes of NIV such as upper airway masks or similar devices will be quantified

Time Frame

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

Title

Re-intubation

Description

Instances of re-intubation will be recorded

Time Frame

From time of end of surgery to patient discharge up to one week

Title

Use of Incentive Spirometry

Description

Frequency of incentive spirometry will be measured

Time Frame

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

Title

Post-operative Nausea and Vomiting

Description

Whether a patient experiences at least one episode of nausea and emesis will be measured

Time Frame

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

Title

Major Organ Dysfunction

Description

Organ systems such as cardiac, renal, respiratory, and nervous system failure/dysfunction in accordance with the Society of Thoracic Surgeon's database will be noted

Time Frame

From date of surgery assessed up to 30 day post-operatively

Title

Length of Hospital and ICU Stay

Description

Length of both hospital and ICU stay will be measured

Time Frame

From date of surgery assessed up to 30 day post-operatively

Title

Hospital Readmission

Description

Readmission to hospital will be noted

Time Frame

From end of surgery assessed up to 30 days post-operatively

Title

Mortality

Description

Mortality will be noted at specific timepoints

Time Frame

From end of surgery assessed up to 30 days post-operatively

Other Pre-specified Outcome Measures:

Title

Delirium

Description

Patients will be assessed for delirium using the Intensive Care Delirium Screening Checklist (ICDSC)

Time Frame

Assessment will be administered at 48 hours post-operatively

Title

Delirium

Description

Patients will be assessed for delirium using the Intensive Care Delirium Screening Checklist (ICDSC)

Time Frame

Assessment will be administered at 72 hours post-operatively

Title

Patient Satisfaction

Description

Patient will give an assessment regarding pain management on a scale of 0 - 10 with 0 indicating the lowest satisfaction with pain management and 10 indicating the highest satisfaction with pain management

Time Frame

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

Title

Chronic Pain Assessment

Description

Subjects will be asked the two following questions: "Are you currently experiencing pain?" as well as "Are you experiencing moderate to severe pain?" with moderate to severe indicated as a pain score of 4-10 on 0 to 10 scale, with 0 being no pain at all and 10 being the worst pain imaginable.

Time Frame

6 months after surgery

Title

Chronic Pain Assessment

Description

Time Frame

12 months after surgery

Title

Serum Cortisol Levels

Description

Stress response suppression as a result of treatment will be evaluated by comparing hormone levels between the groups. Serum cortisol levels will be taken to measure this.

Time Frame

Measured 8, 48, and 72 hours post-operatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kathirvel Subramaniam, MD, MPH

Organizational Affiliation

Associate Professor and staff Anesthesiologist

Official's Role

Principal Investigator

Facility Information:

Facility Name

UPMC Presbyterian Hospital

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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