Pecto-intercostal Fascial Block (PIFB) for Postop Analgesia Following Sternotomy in Cardiac Surgery Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Pecto-intercostal Fascial Block (PIFB) Subjects in this arm receive standard of care PIFB after surgery |
Drug: Pecto-intercostal Fascial Block (PIFB)
PIFB done with bupivacaine and epinephrine
|
| Experimental: PIFB with adjuvants Subjects in this arm receive standard of care PIFB with additional medications after surgery |
Drug: PIFB with adjuvants
PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone
|
Outcome Measures
Primary Outcome Measures
- Area Under the Curve (AUC) Pain Score [6 hours after block placement]
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.
- AUC Pain Score [12 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.
- AUC Pain Score [18 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.
- AUC Pain Score [24 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.
- AUC Pain Score [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
- Patient-reported NRS Pain Scores at Rest [6 hours after block placement]
Pain scores range from 0 to 10 with higher scores denoting more pain.
- Patient-reported NRS Pain Scores at Rest [6, 12, 18, 24, and 36 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]
In milligrams
- Average Time to First Opioid Administration [Up to 36 hours after block placement]
Postoperative after extubation in minutes
- Average Time to Extubation [Up to 36 hours after block placement]
In minutes
- Duration of Intensive Care Unit (ICU) Admission [Up to 36 hours after block placement]
Average number of hours
- Incentive Spirometry Volumes [6, 12, 18, 24, and 36 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.
- Safety Outcome: Nausea Incidence [Up to 36 hours after block placement]
Average number of incidences
- Safety Outcome: Vomiting Incidence [Up to 36 hours after block placement]
Average number of incidences
- Safety Outcome: Postoperative Delirium Incidence [Up to 36 hours after block placement]
Average number of incidences
- 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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wake Forest Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: Rawad Hamzi, MD, Wake Forest University Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00090669