Clinical trial NCT06233318: Sternotomy PIFB Block in Open Heart Surgery
Official title: Efficacy of Bilateral Pecto-Intercostal Fascial Plane Block on Postoperative Pain in Adult Patients Undergoing Open Heart Surgery: a Randomized, Double-blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autonomic Nerve Block
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-center, prospective, randomized, placebo-controlled, double-blinded trial in patients undergoing open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center. All study procedures will be done in accordance with institutional and ORRP-IRB guidelines.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate if the use of a bilateral nerve block with a local anesthetic (ropivacaine), as part of a standard of care pain control regimen (called multimodal analgesia \[MMA\]), has a favorable effect on our institutional MMA pain regimen. Subjects will go through the following study procedures: review of medical history and medications subjects have taken within a month prior to surgery. Subjects will be randomly assigned to one of the two study groups (1:1) to receive either, an ultrasound-guided bilateral nerve block (called "Pecto-Intercostal Fascial Block \[PIFB\]") with ropivacaine or saline 0.9 solution, in addition to our institutional MMA regimen. A baseline line pain and nausea scores will be recorded before surgery. The block will be performed right after general anesthesia induction. The details about the surgery will be collected. Pain assessments, nausea and vomiting scores will be registered at 12, 24 and 48 hours after surgery as well. Lastly, a follow up phone call will be made by the research team to conduct a pain-detect questionnaire at 30, 60 and 90 days after surgery.

Detailed description: Study design This is a single-center, prospective, randomized, placebo-controlled, double-blinded trial in patients undergoing open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center. All study procedures will be done in accordance with institutional and ORRP-IRB guidelines.

Study participants Adult patients undergoing open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center with an American Society of Anesthesiologists (ASA) physical status of I to IV who are scheduled to undergo open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center.

Sample size Eighty-four subjects who give written informed consent to participate in the study and who meet all inclusion and no exclusion criteria will be included in a single treatment group.

Eligibility criteria: Inclusion Criteria:

* Adult male or female patients aged \> 18
* Undergoing primary cardiac surgery requiring sternotomy
* Able to provide a signed written informed consent
* Able to speak, read, and write in English
* American Society of Anesthesiologists (ASA) physical status I-IV

Exclusion Criteria:

* Any documented cognitive or psychological disorders that, in the opinion of the principal investigator, can interfere with the patients' pain perception
* Diabetes Mellitus with documented neuropathic pain
* Vulnerable populations: pregnant females, prisoners, breast feeding
* Contraindication to nerve block: local infections, bleeding disorders, chest wall deformity, allergy to local anesthetic or dexamethasone
* Previous cardiac surgery
* Previous history of chronic pain diseases requiring consistent analgesic therapy for at least 1 month prior to surgery
* Presence of any medical condition that, in the opinion of the principal investigator, should exclude the patient from the study
* BMI ≥ 40 kg/m2

Primary outcomes:
measure: OPIOID consumption at 24 hours
timeFrame: 24 hours after block procedure
measure: OPIOID consumption during surgery
timeFrame: Surgery length
measure: NRS pain score at 48 hours
timeFrame: Up to 48 hours after block procedure
measure: Worst pain score at 48 hours
timeFrame: Up to 48 hours after block procedure
measure: Incidence nausea and/or vomiting after surgery
timeFrame: Up to 48 hours after block procedure
measure: Self-reported satisfaction score at 48 hours
timeFrame: 48 hours after block procedure
measure: pain-DETECT scores at 90 days
timeFrame: Up to 90 days after block procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
References: