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

August 10, 2021 updated by: Kathirvel Subramaniam

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Presbyterian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exparel Injectable Product
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
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)
Other Names:
  • Liposomal Bupivacaine
Active Comparator: Bupivacaine Hydrochloride
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
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)
Other Names:
  • Bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative Pain Intensity
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
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
Time Frame: 0-72 hours post-operative period
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Extubation
Time Frame: From the end of surgery until the patient is extubated up to 72 hours post-operatively
The time it takes until the patient is extubated post-operatively will be measured
From the end of surgery until the patient is extubated up to 72 hours post-operatively
Patient Time to Mobilization
Time Frame: From time of end of surgery to time of mobilization up to 72 hours or discharge, *assessed up to 120 hours*
The time it takes until patient ambulates will be measured
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
Time Frame: From time of end of surgery to time of mobilization up to 72 hours post-operatively
The time it takes until the patient advances from bedrest to out of bed (OOB) to chair will be measured
From time of end of surgery to time of mobilization up to 72 hours post-operatively
Patient Time to Oral Intake
Time Frame: From time of end of surgery to time of oral intake up to 72 hours post-operatively or until hospital discharge
The time it takes until the patient is able to/medically cleared to consume food or liquid will be measured
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
Time Frame: From time of end of surgery to 72 hours post-operatively or until hospital discharge
Episodes of NIV such as upper airway masks or similar devices will be quantified
From time of end of surgery to 72 hours post-operatively or until hospital discharge
Re-intubation
Time Frame: From time of end of surgery to patient discharge up to one week
Instances of re-intubation will be recorded
From time of end of surgery to patient discharge up to one week
Use of Incentive Spirometry
Time Frame: From time of end of surgery to 72 hours post-operatively
Frequency of incentive spirometry will be measured
From time of end of surgery to 72 hours post-operatively
Post-operative Nausea and Vomiting
Time Frame: From time of end of surgery to 72 hours post-operatively
Whether a patient experiences at least one episode of nausea and emesis will be measured
From time of end of surgery to 72 hours post-operatively
Major Organ Dysfunction
Time Frame: From date of surgery assessed up to 30 day post-operatively
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
From date of surgery assessed up to 30 day post-operatively
Length of Hospital and ICU Stay
Time Frame: From date of surgery assessed up to 30 day post-operatively
Length of both hospital and ICU stay will be measured
From date of surgery assessed up to 30 day post-operatively
Hospital Readmission
Time Frame: From end of surgery assessed up to 30 days post-operatively
Readmission to hospital will be noted
From end of surgery assessed up to 30 days post-operatively
Mortality
Time Frame: From end of surgery assessed up to 30 days post-operatively
Mortality will be noted at specific timepoints
From end of surgery assessed up to 30 days post-operatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delirium
Time Frame: Assessment will be administered at 48 hours post-operatively
Patients will be assessed for delirium using the Intensive Care Delirium Screening Checklist (ICDSC)
Assessment will be administered at 48 hours post-operatively
Delirium
Time Frame: Assessment will be administered at 72 hours post-operatively
Patients will be assessed for delirium using the Intensive Care Delirium Screening Checklist (ICDSC)
Assessment will be administered at 72 hours post-operatively
Patient Satisfaction
Time Frame: Given at the time of discharge up to 30 days post-operatively
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
Given at the time of discharge up to 30 days post-operatively
Chronic Pain Assessment
Time Frame: 6 months after surgery
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.
6 months after surgery
Chronic Pain Assessment
Time Frame: 12 months after surgery
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.
12 months after surgery
Serum Cortisol Levels
Time Frame: Measured 8, 48, and 72 hours post-operatively
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.
Measured 8, 48, and 72 hours post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kathirvel Subramaniam

Collaborators

Pacira Pharmaceuticals, Inc

Investigators

  • Principal Investigator: Kathirvel Subramaniam, MD, MPH, Associate Professor and staff Anesthesiologist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2018

Primary Completion (Actual)

December 13, 2019

Study Completion (Actual)

February 25, 2020

Study Registration Dates

First Submitted

August 10, 2017

First Submitted That Met QC Criteria

August 29, 2017

First Posted (Actual)

September 1, 2017

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

August 10, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO17060305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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