Analgesia Clinical Trial
Official title:
Pecto-intercostal Fascial Block With Perineural Adjuvants for Postoperative Analgesia Following Sternotomy in Patients Undergoing Cardiac Surgery
Verified date | April 2024 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
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 |
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