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Completed

NCT Number: NCT04928339

Pecto-Intercostal Fascial Plane Block Study

This study is being done to see if bilateral pecto-intercostal fascial plane blocks (PIFB) with a mixture of liposomal and standard bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline). 100 participants will be recruited and can expect to be on study for 100 days.

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Key information

Conditions

Cardiac Surgery Opioid Use, Unspecified

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

About this study

Thousands of heart surgeries are performed every day in the United States. Unattenuated perioperative pain has been shown to contribute to increased morbidity, mortality, length of stay, and healthcare costs. Practice guidelines from the American Society of Regional Anesthesiologists recommend pre-incision techniques to reduce perioperative pain, however in cardiac surgery, there are no commonly used techniques to follow this recommendation. The PIFB is a newly described fascial plane block and existing literature supports the safety and efficacy of the PIFB in cardiac surgery patients. However, there are no randomized controlled trials evaluating this technique with a long-acting depot local anesthetic.

The purpose of this study is to determine whether bilateral pecto-intercostal fascial plane blocks with liposomal bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline). The primary hypothesis is that patients receiving effective regional anesthesia with liposomal bupivacaine via PIFB will demonstrate a clinically significant (25%) reduction in total daily opioid consumption through 72 hours postoperatively compared to patients receiving standard of care without effective regional anesthesia (saline only via PIFB).

This study is a prospective, single-center, randomized, double-blind, controlled trial to evaluate whether bilateral pecto-intercostal fascial plane blocks with liposomal and standard bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline).

The participants will be randomized to receive bilateral PIFB with a mixture of standard and liposomal bupivacaine or bilateral PIFB with saline only. Recovery characteristics, including opioid consumption, pain scores, duration of mechanical ventilation, ICU length of stay, hospital length of stay, side effects, and chronic opioid use will be evaluated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participant provides consent to participate in study
  • Ideal body weight (IBW) is >50kg
  • Participant is planned to undergo coronary artery bypass graft or single valve repair/replacement surgery via median sternotomy
  • Participant is undergoing an elective procedure

Exclusion criteria

  • Participant is unable or unwilling to give consent
  • Non-English speaking
  • Known or believed to be pregnant or is currently breastfeeding
  • Participant is a prisoner
  • Clinically unstable per discretion of the Investigator
  • Participant requires urgent/emergent surgery
  • History of previous sternotomy
  • Preoperative coagulopathy (INR >1.4, platelets <100,000) or ongoing anticoagulation or anti-platelet therapy (except aspirin 81mg)
  • Allergy or sensitivity to amide-type local anesthetics, dexmedetomidine or ketamine
  • Participant has decompensated heart failure
  • Severe left ventricle dysfunction (defined quantitatively as an ejection fraction of less than or equal to 35%) or right ventricle dysfunction (defined qualitatively as "severe")
  • Diagnosis of cirrhosis or end-stage liver disease
  • Requires the use of mechanical circulatory support pre-operatively
  • Participant uses chronic opioids (meaning at the time of the preoperative screening evaluation by the study team, the patient is prescribed and taking any opioid pain medication)

Treatment and study plan

Bupivacaine Injection

Drug

10mL of 0.25% bupivacaine

Liposomal bupivacaine

Drug

15mL of 133mg liposomal bupivacaine

Saline

Other

25mL saline control

Primary outcomes

  1. Total Opioid Consumption 72 Hours Post-operatively

    Time frame: up to 72 hours post-operatively

    Total opioid consumption during the initial 72 hours post-operatively will be measured in morphine milligram equivalents (MME) and compared between groups.

Secondary outcomes

  1. Total Intraoperative Opioid Consumption

    Time frame: intraoperative period ranging from anesthesia start time to anesthesia end time

    Total intraoperative opioid consumption will be measured in morphine milligram equivalents (MME) and compared between groups.

  2. Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op

    Time frame: data collected immediately post-op, 24 hours, 48 hours, and 72 hours post-operatively

    Pain will be assessed, according to standard of care, every 4 hours using the 11-point Numerical Rating Scale (NRS), beginning at time 0 (arrival to ICU). Each patient's pain scores (higher scores indicate worse pain) within each postoperative day will be averaged, and the mean pain scores during each day and throughout the first 72 hours will be compared between the intervention and control groups. Median pain scores at 24, 48 and 72 hours post-op will be interrogated.

    Participants described their pain as low (range of 0-4), medium (range of 5-7) or high (range of 8-10).

  3. Maximum Pain Scores up to 72 Hours Postoperatively

    Time frame: up to 72 hours post-op

    Pain will be assessed, according to standard of care, every 4 hours using the 9-point Numerical Rating Scale (NRS) where higher score indicate worse pain, beginning at time 0 (arrival to ICU). The number of Participants reporting a Maximum pain score at 72 hours postoperatively will be reported. Participants described their pain as low (range of 0-4), medium (range of 5-7) or high (range of 8-9).

  4. Pain Score at 90 Days Postoperatively

    Time frame: up to 90 days post-op

    Pain will be assessed, according to standard of care, every 4 hours using the 11-point Numerical Rating Scale (NRS) where higher score indicate worse pain. Pain at 90 days postoperative will be surveyed by phone. Pain will be assessed participants described their pain as low (range of 0-4), medium (range of 5-7) or high (range of 8-10).

  5. Daily Opioid Consumption up to 72 Hours Postoperatively

    Time frame: up to 72 hours post-op

    Daily opioid consumption during the initial 72 hours postoperatively will be measured in milligrams of morphine equivalents and compared between groups.

  6. Hours of Mechanical Ventilation After ICU Admission

    Time frame: up to 72 hours post-op

    Duration of mechanical ventilation will be measured by hours of mechanical ventilation after admission to the ICU.

  7. Number of Postoperative Days Until the First Bowel Movement

    Time frame: up to 72 hours post-op

    Return of bowel function will be measured in the number of postoperative days until the first bowel movement.

  8. Number of Participants Reporting Postoperative Delirium Episodes Per the Confusion Assessment Method for the ICU (CAM-ICU)

    Time frame: up to 72 hours post-op

    Postoperative delirium episodes will be measured according to standard of care by utilizing the CAM-ICU assessment every 8-12 hours. The CAM-ICU determines either 'yes' or 'no' the participant is experiencing delirium. The number of of delirium episodes within 72 hours post-op will be determined.

  9. Number of Hours That the Patient is in the ICU

    Time frame: up to 72 hours post-op

    Duration of ICU stay will be measured by the number of hours that the patient is in the ICU until an order is placed for transfer to a lower level of care.

  10. Number of Post-operative Days Until the Patient is Discharged

    Time frame: Up to 7 days

    Duration of hospital stay will be measured by the number of post-operative days until the patient is discharged.

  11. Count of Participants Using Opioids at 90 Days Postoperatively

    Time frame: up to 90 days post-op

    Patient use of opioids at 90 days will be obtained by phone call.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Pecto-Intercostal Fascial Plane Block for Enhanced Recovery After Cardiac Surgery

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 16, 2021
Registry last updated
Nov 19, 2024

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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