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

NCT05676814 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00090669
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia; Sternotomy

Keywords

Pecto-intercostal Fascial Block; Postoperative; Pain; Cardiac Surgery

Outcome Measures

Primary Outcomes (5)

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

  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.

  0 to 6 hours after block placement

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

  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

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

  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

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

  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

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

  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 Outcomes (11)

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

  6 hours after block placement

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

  6, 12, 18, 24 hours after block placement

• Average Cumulative Opioid Consumption

  36 hours after block placement

• Average Time to First Opioid Administration

  Up to 36 hours after block placement

• Average Time to Extubation

  Up to 36 hours after block placement

Study Arms (2)

Pecto-intercostal Fascial Block (PIFB)

ACTIVE COMPARATOR

Subjects in this arm receive standard of care PIFB after surgery

Drug: Pecto-intercostal Fascial Block (PIFB)

PIFB with adjuvants

EXPERIMENTAL

Subjects in this arm receive standard of care PIFB with additional medications after surgery

Drug: PIFB with adjuvants

Interventions

Pecto-intercostal Fascial Block (PIFB) DRUG

PIFB done with bupivacaine and epinephrine

Pecto-intercostal Fascial Block (PIFB)

PIFB with adjuvants DRUG

PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone

PIFB with adjuvants

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults between undergoing cardiac surgery involving sternotomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Agnosia; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Scott Coleman, DO
• Organization: Wake Forest University Health Sciences

srcolema@wakehealth.edu

336-716-2712

Study Officials

• Scott Coleman, DO

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be blinded to their treatment arm assignment, as will all research personnel who be responsible for collection of outcome data, as well as the surgeons performing the procedure, and critical care staff caring for the patients in the postoperative period. The anesthesiologist who will be performing the Pecto-intercostal Fascial Block (PIFB) will open the envelope informing them of the arm assignment; they will be the only care providers unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 9, 2023
• Study Start: March 24, 2023
• Primary Completion: June 23, 2023
• Study Completion: June 24, 2023
• Last Updated: June 11, 2024
• Results First Posted: June 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)