Phase 4 N=31 Randomized Quadruple-blind Treatment

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

Analgesia · Sternotomy

Bottom Line

View on ClinicalTrials.gov: NCT05676814 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2024

Primary outcome: Primary: Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores — 6.39; 4.22 scores on a scale*hour

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Pecto-intercostal Fascial Block (PIFB) (Drug); PIFB with adjuvants (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Jun 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores	—	—
PRIMARY Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores	—	—
PRIMARY Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores	—	—
PRIMARY Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores	—	—
PRIMARY Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores	—	—
SECONDARY Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest	5.25; 3.43; 2.67; 3.14; 2.45; 3.5	—
SECONDARY Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest	5.25; 3.43; 2.67; 3.14; 2.45; 3.5	—
SECONDARY Average Cumulative Opioid Consumption	—	—
SECONDARY Average Time to First Opioid Administration	—	—
SECONDARY Average Time to Extubation	276.815; 232.020	—
SECONDARY Duration of Intensive Care Unit (ICU) Admission	50.620; 51.541	—
SECONDARY Incentive Spirometry Volumes	2750; 3427.08; 525; 1333.33; 968.06; 1519.44	—
SECONDARY Safety Outcome: Nausea Incidence	—	—
SECONDARY Safety Outcome: Vomiting Incidence	—	—
SECONDARY Safety Outcome: Postoperative Delirium Incidence	—	—
SECONDARY Numeric Rating Scale (NRS) Satisfaction With the Analgesic Regimen	7.92; 8.88	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05676814). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.