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Completed

NCT Number: NCT03270514

Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. 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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Stenoses Coronary Disease Coronary Stenosis Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency Myocardial Ischemia Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Tricuspid Valve Insufficiency Valve Regurgitation, Mitral Valve Regurgitation, Tricuspid Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Other names: Liposomal Bupivacaine

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)

Other names: Bupivacaine

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Re-intubation

    Time frame: From time of end of surgery to patient discharge up to one week

    Instances of re-intubation will be recorded

  7. Use of Incentive Spirometry

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

    Frequency of incentive spirometry will be measured

  8. 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

  9. 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

  10. 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

  11. Hospital Readmission

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

    Readmission to hospital will be noted

  12. Mortality

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

    Mortality will be noted at specific timepoints

Other outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Kathirvel Subramaniam

Other

Collaborators

  • Pacira Pharmaceuticals, Inc

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Sep 1, 2017
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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