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

Phase 4

Completed

Conditions: Analgesia
Sternotomy

Interventions: Drug: Pecto-intercostal Fascial Block (PIFB)
Drug: PIFB with adjuvants

Registration Number: NCT05676814

Lead Sponsor: Wake Forest University Health Sciences

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 31

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pecto-intercostal Fascial Block (PIFB)	Pecto-intercostal Fascial Block (PIFB)	Subjects in this arm receive standard of care PIFB after surgery
PIFB with adjuvants	PIFB with adjuvants	Subjects in this arm receive standard of care PIFB with additional medications after surgery

Primary Outcome Measures

Name	Time	Method
Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores	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 Outcome Measures

Name	Time	Method
Safety Outcome: Nausea Incidence	Up to 36 hours after block placement	Average number of incidences of Nausea
Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest	6, 12, 18, 24 hours after block placement	Pain scores range from 0 to 10 with higher scores denoting more pain.
Average Cumulative Opioid Consumption	36 hours after block placement	Average Cumulative Opioid Consumption in milligrams
Average Time to First Opioid Administration	Up to 36 hours after block placement	Average Time to First Opioid Administration - Postoperative after extubation measured in minutes
Incentive Spirometry Volumes	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.
Average Time to Extubation	Up to 36 hours after block placement	Average Time to Extubation - measured in minutes
Duration of Intensive Care Unit (ICU) Admission	Up to 52 hours after block placement	Duration of Intensive Care Unit (ICU) Admission - measured in Average number of hours.
Safety Outcome: Vomiting Incidence	Up to 36 hours after block placement	Average number of Vomiting incidences
Safety Outcome: Postoperative Delirium Incidence	Up to 36 hours after block placement	Average number of Delirium incidences
Numeric Rating Scale (NRS) Satisfaction With the Analgesic Regimen	36 hours after block placement	Patient-reported scores range from 0-10 where 0 represents completely unsatisfied and 10 represents completely satisfied.