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Completed

NCT Number: NCT05676814

Pecto-intercostal Fascial Block (PIFB) for Postop Analgesia Following Sternotomy in Cardiac Surgery Patients

The purpose of this randomized, triple-blinded, prospective, feasibility study is to compare postoperative analgesia provided by Pecto-intercostal Fascial Block (PIFB) when performed with local anesthetic solution with or without perineural adjuvants in patients following cardiac surgery involving sternotomy. The study team hypothesizes that the patients receiving PIFB with bupivacaine with epinephrine, clonidine, and dexamethasone will have lower dynamic pain over the first 36 hours compared to those receiving PIFB with just bupivacaine and epinephrine.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

This will be a randomized, triple-blinded, prospective, feasibility trial. Written informed consent will be obtained from all study participants prior to randomization. Patients scheduled to undergo cardiac surgery involving sternotomy at Atrium Health Wake Forest Baptist will be screened for eligibility. These patients will be approached for enrollment by research staff either during their preoperative assessment clinic visit prior to their surgery date, or when admitted as inpatients and scheduled for surgery. Subjects chosen to participate will be randomized into one or other arm and PIFB will be performed after skin closure and before transport from the operating room to the ICU. For patients who are randomized at enrollment but later excluded due to exclusion criteria prior to block placement, their randomization assignment will be replaced at the end of the initial recruitment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults between undergoing cardiac surgery involving sternotomy

Exclusion criteria

  • Patients with any contraindications to regional anesthesia, such as history of allergy to amide local anesthetics or any of the perineural adjuvants
  • existing neurologic deficit in the chest wall;
  • remaining intubated at the six hour point after block placement
  • weight under 50kg
  • undergoing emergency surgical procedures or urgent return to the operating room
  • active endocarditis or mediastinitis
  • moderate to severe right ventricular function before or after cardiopulmonary bypass
  • reliance on mechanical circulatory support devices, such as intra-aortic balloon pump or Impella
  • reliance on extracorporeal membrane oxygenation
  • localized or systemic infection
  • chronic use of high dose opioid analgesics (defined as daily use greater than 30 oral morphine milligram equivalents (OMME) for over one month prior to surgery)
  • those who are pregnant

Treatment and study plan

Pecto-intercostal Fascial Block (PIFB)

Drug

PIFB done with bupivacaine and epinephrine

PIFB with adjuvants

Drug

PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone

Primary outcomes

  1. Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores

    Time frame: 0 to 6 hours after block placement

    Based on patient-reported dynamic Numerical Rating Scale (NRS) pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain. 0 to 6 hrs after placement.

  2. Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores

    Time frame: 12 hours after block placement

    Based on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain.

  3. Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores

    Time frame: 18 hours after block placement

    Based on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain.

  4. Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores

    Time frame: 24 hours after block placement

    Based on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain.

  5. Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores

    Time frame: 36 hours after block placement

    Based on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain.

Secondary outcomes

  1. Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest

    Time frame: 6 hours after block placement

    Pain scores range from 0 to 10 with higher scores denoting more pain.

  2. Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest

    Time frame: 6, 12, 18, 24 hours after block placement

    Pain scores range from 0 to 10 with higher scores denoting more pain.

  3. Average Cumulative Opioid Consumption

    Time frame: 36 hours after block placement

    Average Cumulative Opioid Consumption in milligrams

  4. Average Time to First Opioid Administration

    Time frame: Up to 36 hours after block placement

    Average Time to First Opioid Administration - Postoperative after extubation measured in minutes

  5. Average Time to Extubation

    Time frame: Up to 36 hours after block placement

    Average Time to Extubation - measured in minutes

  6. Duration of Intensive Care Unit (ICU) Admission

    Time frame: Up to 52 hours after block placement

    Duration of Intensive Care Unit (ICU) Admission - measured in Average number of hours.

  7. Incentive Spirometry Volumes

    Time frame: 6, 12, 18, 24 hours after block placement

    An incentive spirometer is a handheld medical device that measures the volume of subject's breath. The volume of air displaced is indicated in milliliters on a scale located on the device enclosure. This device measures what is called vital capacity, the amount of air that is breathed in and out of the lungs.

  8. Safety Outcome: Nausea Incidence

    Time frame: Up to 36 hours after block placement

    Average number of incidences of Nausea

  9. Safety Outcome: Vomiting Incidence

    Time frame: Up to 36 hours after block placement

    Average number of Vomiting incidences

  10. Safety Outcome: Postoperative Delirium Incidence

    Time frame: Up to 36 hours after block placement

    Average number of Delirium incidences

  11. Numeric Rating Scale (NRS) Satisfaction With the Analgesic Regimen

    Time frame: 36 hours after block placement

    Patient-reported scores range from 0-10 where 0 represents completely unsatisfied and 10 represents completely satisfied.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Pecto-intercostal Fascial Block With Perineural Adjuvants for Postoperative Analgesia Following Sternotomy in Patients Undergoing Cardiac Surgery

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 9, 2023
Registry last updated
Jun 11, 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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