Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157, United States
NCT Number: NCT05676814
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.
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Notify Me18 year–90 year
All sexes
Interventional
Phase 4
Winston-Salem, North Carolina, 27157, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PIFB done with bupivacaine and epinephrine
PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone
Time frame: 0 to 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. 0 to 6 hrs after placement.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 hours after block placement
Pain scores range from 0 to 10 with higher scores denoting more pain.
Time frame: 6, 12, 18, 24 hours after block placement
Pain scores range from 0 to 10 with higher scores denoting more pain.
Time frame: 36 hours after block placement
Average Cumulative Opioid Consumption in milligrams
Time frame: Up to 36 hours after block placement
Average Time to First Opioid Administration - Postoperative after extubation measured in minutes
Time frame: Up to 36 hours after block placement
Average Time to Extubation - measured in minutes
Time frame: Up to 52 hours after block placement
Duration of Intensive Care Unit (ICU) Admission - measured in Average number of hours.
Time frame: 6, 12, 18, 24 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. This device measures what is called vital capacity, the amount of air that is breathed in and out of the lungs.
Time frame: Up to 36 hours after block placement
Average number of incidences of Nausea
Time frame: Up to 36 hours after block placement
Average number of Vomiting incidences
Time frame: Up to 36 hours after block placement
Average number of Delirium incidences
Time frame: 36 hours after block placement
Patient-reported scores range from 0-10 where 0 represents completely unsatisfied and 10 represents completely satisfied.
Wake Forest University Health Sciences
Other
Pecto-intercostal Fascial Block With Perineural Adjuvants for Postoperative Analgesia Following Sternotomy in Patients Undergoing Cardiac Surgery
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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