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

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Sternotomy
• Intervention / Treatment: Drug: Pecto-intercostal Fascial Block (PIFB); Drug: PIFB with adjuvants

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Rawad Hamzi, MD; Phone Number: 336-716-4498; Email: rhamzi@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Health Sciences
      • Contact: Rawad Hamzi, MD; Phone Number: 336-716-4498; Email: rhamzi@wakehealth.edu
      • Contact: Lynnette Harris, BSN; Phone Number: 336-716-8791; Email: lcharris@wakehealth.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pecto-intercostal Fascial Block (PIFB); Subjects in this arm receive standard of care PIFB after surgery	Drug: Pecto-intercostal Fascial Block (PIFB); PIFB done with bupivacaine and epinephrine
Experimental: PIFB with adjuvants; Subjects in this arm receive standard of care PIFB with additional medications after surgery	Drug: PIFB with adjuvants; PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve (AUC) Pain Score	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.	6 hours after block placement
AUC Pain Score	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.	12 hours after block placement
AUC Pain Score	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.	18 hours after block placement
AUC Pain Score	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.	24 hours after block placement
AUC Pain Score	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.	36 hours after block placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported NRS Pain Scores at Rest	Pain scores range from 0 to 10 with higher scores denoting more pain.	6 hours after block placement
Patient-reported NRS Pain Scores at Rest	Pain scores range from 0 to 10 with higher scores denoting more pain.	6, 12, 18, 24, and 36 hours after block placement
Average Cumulative Opioid Consumption	In milligrams	36 hours after block placement
Average Time to First Opioid Administration	Postoperative after extubation in minutes	Up to 36 hours after block placement
Average Time to Extubation	In minutes	Up to 36 hours after block placement
Duration of Intensive Care Unit (ICU) Admission	Average number of hours	Up to 36 hours after block placement
Incentive Spirometry Volumes	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.	6, 12, 18, 24, and 36 hours after block placement
Safety Outcome: Nausea Incidence	Average number of incidences	Up to 36 hours after block placement
Safety Outcome: Vomiting Incidence	Average number of incidences	Up to 36 hours after block placement
Safety Outcome: Postoperative Delirium Incidence	Average number of incidences	Up to 36 hours after block placement
NRS Satisfaction with the Analgesic Regimen	Patient-reported scores range from 0-10 where 0 represents completely unsatisfied and 10 represents completely satisfied.	36 hours after block placement

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Rawad Hamzi, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2023
• Primary Completion (Actual): June 23, 2023
• Study Completion (Actual): June 24, 2023

Study Registration Dates

• First Submitted: December 22, 2022
• First Submitted That Met QC Criteria: December 22, 2022
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Cardiac Surgery; Postoperative; Pecto-intercostal Fascial Block
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID Numbers: IRB00090669

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No