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Completed

NCT Number: NCT04908449

Pectointercostal Fascial Plane Block (PIFB) Alone Versus PIFB With Rectus Sheath Block (RSB) in Cardiac Surgery

The purpose of this study is to determine if ultrasound-guided bilateral pectointercostal fascial plane blocks with bilateral rectus sheath blocks block decrease pain scores, decrease opioid consumption, improve respiratory function, and improve quality of recovery in patients recovering from elective cardiac surgery involving primary median sternotomy and mediastinal chest tubes in comparison to pectointercostal fascial plane blocks alone.

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Key information

About this study

This is a single center, prospective, randomized, controlled, double-blinded study. We anticipate recruitment of 62 subjects, with 25-30 in each group.

Primary Outcomes:

Pain scores on a 0-10 visual analog scale (VAS) at rest and with deep breathing at 1, 3, 6, 12, 18, and 24 hours post-extubation between subjects receiving PIFB + RSB versus subjects receiving only PIFB.

Total cumulative opioid consumption at 24 and 48 hours post-operatively.

Secondary Outcomes:

  • Intraoperative total opioid consumption
  • Change from baseline on incentive spirometry at 1, 3, 12, and 24 hours post-extubation
  • Time from ICU arrival to liberation from mechanical ventilation
  • QoR-15 (Quality of Recovery) score23 24 hours after extubation
  • Hospital and ICU length of stay

Preoperative Management :

Subjects will be randomized on the morning of surgery to receive bilateral PIFB and bilateral RSB with local anesthetic versus bilateral PIFB with local anesthetic and bilateral RSB with saline (placebo).

Intraoperative Management All subjects will receive the standard of care anesthetic regimen for their cardiac surgery.

Postoperative Management Each PIFB will be performed with 15 mL of 0.25% bupivacaine with 5 mcg/ml of epinephrine, and bilateral RSB will be performed with an additional 20 mL of 0.25% bupivacaine with 5 mcg/ml of epinephrine (10mL on each side).

Postoperative Evaluation:

Evaluation of acute postoperative pain intensity using a 0-10 visual analog scale (VAS) will be undertaken at the following time points, both at rest and with deep breathing:

  • 1, 3, 6, 12, 18, and 24 hours post-extubation Incentive spirometry will be assessed at 1, 3, 12, and 24 hours post-extubation, with three measures taken at each time point in order to compare postoperative performance with baseline spirometry.

Review of the medical chart will be made post-operatively to gather other data, including total intraoperative oral morphine equivalent consumption, cumulative opioid consumption at 24 and 48 hours, time from ICU arrival to tracheal extubation, hospital and ICU length of stay, and QoR-15 (Quality of Recovery) score administered 24 hours after extubation (with margin of error of 18-30 hours to avoid waking patients in the middle of the night) . Occurrences of any adverse events reported by the subject or medical team will also be collected.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects scheduled for cardiac surgery involving primary median sternotomy and mediastinal chest tubes.
  • Age 18-85 years of age
  • BMI 18-50 kg/m2
  • Weight > 60 kg

Exclusion criteria

  • Left ventricular ejection fraction (LVEF) < 30%
  • Preoperative, intraoperative, or immediate post-operative placement of intra-aortic balloon pump or deployment of extra-corporeal membrane oxygenation (ECMO)
  • Inability to understand or speak English
  • Allergy to bupivacaine or other amide local anesthetic
  • Contraindication to peripheral nerve block (e.g. local infection, previous trauma to the block site)
  • Chronic opioid consumption (daily oral morphine equivalent of >20 mg) in the past three months
  • Severe pulmonary or hepatic disease
  • Neurological deficit or disorder
  • Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past two years
  • Uncontrolled anxiety, schizophrenia, or other severe psychiatric disorder

Treatment and study plan

Rectus sheath block with bupivacaine

Drug

Rectus sheath block with local anesthetic versus sham block with saline

Other names: Rectus sheath block with saline placebo

Primary outcomes

  1. Pain Scores at Rest Within the First 24 Hours After Extubation

    Time frame: 24 hours after extubation

    Measured by area under the curve (AUC) for pain scores gathered at 1, 3, 6, 12, 18, and 24 hours after extubation. To calculate the Area Under the Curve (AUC) for pain scores, pain intensity is plotted against time and the trapezoidal rule is used to approximate the area under the resulting curve. This AUC value represents the overall pain experience, considering both pain intensity and duration. Scale 0-240, with higher indicating a worse outcome. Units: Numeric rating score * hours.

  2. Pain Scores With Deep Breathing Within the First 24 Hours After Extubation

    Time frame: 24 hours after extubation

    Measured by area under the curve (AUC) for pain scores gathered at 1, 3, 6, 12, 18, and 24 hours after extubation. To calculate the Area Under the Curve (AUC) for pain scores, pain intensity is plotted against time and the trapezoidal rule is used to approximate the area under the resulting curve. This AUC value represents the overall pain experience, considering both pain intensity and duration. Scale 0-240, with higher indicating a worse outcome. Units: Numeric rating score * hours.

  3. Total Cumulative Opioid Consumption

    Time frame: 24 hours post-operatively

    Total cumulative opioid consumption at 24 hours

  4. Total Cumulative Opioid Consumption

    Time frame: 48 hours post-operatively

    Total cumulative opioid consumption at 48 hours

Secondary outcomes

  1. Time From ICU Arrival to Liberation From Mechanical Ventilation

    Time frame: ICU arrival until extubation

    Time from ICU arrival as measured by "anesthesia stop" to liberation from mechanical ventilation (extubation).

  2. Vital Capacity Change From Baseline on Incentive Spirometry

    Time frame: 1 hour post-extubation

    Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL).

  3. Vital Capacity Change From Baseline on Incentive Spirometry

    Time frame: 3 hours post-extubation

    Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL).

  4. Vital Capacity Change From Baseline on Incentive Spirometry

    Time frame: 12 hours post-extubation

    Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL).

  5. Vital Capacity Change From Baseline on Incentive Spirometry

    Time frame: 24 hours post-extubation

    Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL).

  6. QoR-15 (Quality of Recovery) Score

    Time frame: 24 hours after extubation

    QoR-15 (Quality of Recovery) score is a 15 question survey asking patients about various aspects of their quality of recovery, including pain control, nausea, anxiety, depression, ability to eat, etc. The scale is 0-150, with higher scores indicating a better outcome.

  7. ICU Length of Stay

    Time frame: Time from anesthesia stop to transfer out of ICU, typically 24 hours

    ICU Length of Stay in hours, as measured by anesthesia stop until transfer out of the ICU.

  8. Hospital Length of Stay

    Time frame: Time from anesthesia stop to hospital discharge, typically one week

    Hospital Length of Stay in hours, as measured by anesthesia stop until discharge from the hospital.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

A Comparison of the Analgesic Effects of Pectointercostal Fascial Plane Block (PIFB) Alone Versus PIFB With Rectus Sheath Block (RSB) in Cardiac Surgery: a Prospective, Randomized Controlled Trial.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 1, 2021
Registry last updated
Nov 17, 2025

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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