Clinical trial NCT05676814: Pecto-intercostal Fascial Block (PIFB) for Postop Analgesia Following Sternotomy in Cardiac Surgery Patients
Official title: Pecto-intercostal Fascial Block With Perineural Adjuvants for Postoperative Analgesia Following Sternotomy in Patients Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Analgesia
Sternotomy
Keywords: Pecto-intercostal Fascial Block
Postoperative
Pain
Cardiac Surgery
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores
timeFrame: 0 to 6 hours after block placement
measure: Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores
timeFrame: 12 hours after block placement
measure: Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores
timeFrame: 18 hours after block placement
measure: Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores
timeFrame: 24 hours after block placement
measure: Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores
timeFrame: 36 hours after block placement
Secondary outcomes:
measure: Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest
timeFrame: 6 hours after block placement
measure: Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest
timeFrame: 6, 12, 18, 24 hours after block placement
measure: Average Cumulative Opioid Consumption
timeFrame: 36 hours after block placement
measure: Average Time to First Opioid Administration
timeFrame: Up to 36 hours after block placement
measure: Average Time to Extubation
timeFrame: Up to 36 hours after block placement
measure: Duration of Intensive Care Unit (ICU) Admission
timeFrame: Up to 52 hours after block placement
measure: Incentive Spirometry Volumes
timeFrame: 6, 12, 18, 24 hours after block placement
measure: Safety Outcome: Nausea Incidence
timeFrame: Up to 36 hours after block placement
measure: Safety Outcome: Vomiting Incidence
timeFrame: Up to 36 hours after block placement
measure: Safety Outcome: Postoperative Delirium Incidence
timeFrame: Up to 36 hours after block placement
measure: Numeric Rating Scale (NRS) Satisfaction With the Analgesic Regimen
timeFrame: 36 hours after block placement
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Scott Coleman, DO
role: PRINCIPAL_INVESTIGATOR
References: