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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05676814
• Other study ID #: IRB00090669
• Status: Completed
• Phase: Phase 4
• Start date: March 24, 2023
• Est. completion date: June 24, 2023

Study information

• Verified date: April 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 24, 2023
• Est. primary completion date: June 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Sternotomy

Intervention

Drug:
• Pecto-intercostal Fascial Block (PIFB)
PIFB done with bupivacaine and epinephrine
• PIFB with adjuvants
PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone

Locations

Country	Name	City	State
United States	Wake Forest Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest	Pain scores range from 0 to 10 with higher scores denoting more pain.	6 hours after block placement
Secondary	Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest	Pain scores range from 0 to 10 with higher scores denoting more pain.	6, 12, 18, 24 hours after block placement
Secondary	Average Cumulative Opioid Consumption	Average Cumulative Opioid Consumption in milligrams	36 hours after block placement
Secondary	Average Time to First Opioid Administration	Average Time to First Opioid Administration - Postoperative after extubation measured in minutes	Up to 36 hours after block placement
Secondary	Average Time to Extubation	Average Time to Extubation - measured in minutes	Up to 36 hours after block placement
Secondary	Duration of Intensive Care Unit (ICU) Admission	Duration of Intensive Care Unit (ICU) Admission - measured in Average number of hours.	Up to 52 hours after block placement
Secondary	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. This device measures what is called vital capacity, the amount of air that is breathed in and out of the lungs.	6, 12, 18, 24 hours after block placement
Secondary	Safety Outcome: Nausea Incidence	Average number of incidences of Nausea	Up to 36 hours after block placement
Secondary	Safety Outcome: Vomiting Incidence	Average number of Vomiting incidences	Up to 36 hours after block placement
Secondary	Safety Outcome: Postoperative Delirium Incidence	Average number of Delirium incidences	Up to 36 hours after block placement
Secondary	Numeric Rating Scale (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