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

Kathirvel Subramaniam60 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

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

Interventions

Exparel Injectable ProductDRUG

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)

Bupivacaine HydrochlorideDRUG

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

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

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

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.

Time frame: 0-72 hours post-operative period

Secondary Outcomes

Time to Extubation

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

Patient Time to Mobilization

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*

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

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

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

Data from ClinicalTrials.gov

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