Sternotomy PIFB Block in Open Heart Surgery
ConditionAutonomic Nerve Block
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine
Procedure/SurgeryThe US probe will be placed at sagittal plane, 2 cm lateral to the midline of the sternum to identify the second to the fifth costal cartilage from the ribs. Consequently, the US probe will be positioned in the space between the fourth and fifth costal cartilages at the sternum. After identifying the fascial planes of the chest wall, the pectoralis major muscle (PMM), the external intercostal muscle (EIM), the costal cartilage, the pleura, and the lungs. A sterile 22G blunt Stimuplex, 50 mm needle (B. Braun, Bethlehem, Pa) will be advanced and placed under the PMM and above the EIM. Following negative aspiration, PN solution with investigational product according to group randomization/allocation will be injected at each side in 5 mL aliquots ensuring appropriate spread of the PN solution. The separation of the fascial plane and the spread of the drug will be observed on the ultrasound image in real time.
Pecto-intercostal Fascial Block with normal saline
Procedure/SurgeryThe US probe will be placed at sagittal plane, 2 cm lateral to the midline of the sternum to identify the second to the fifth costal cartilage from the ribs. Consequently, the US probe will be positioned in the space between the fourth and fifth costal cartilages at the sternum. After identifying the fascial planes of the chest wall, the pectoralis major muscle (PMM), the external intercostal muscle (EIM), the costal cartilage, the pleura, and the lungs. A sterile 22G blunt Stimuplex, 50 mm needle (B. Braun, Bethlehem, Pa) will be advanced and placed under the PMM and above the EIM. Following negative aspiration, PN solution with investigational product according to group randomization/allocation will be injected at each side in 5 mL aliquots ensuring appropriate spread of the PN solution. The separation of the fascial plane and the spread of the drug will be observed on the ultrasound image in real time.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Pecto-intercostal fascial blockActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
OPIOID consumption at 24 hours
To compare the effect of bilateral PIFB on perioperative opioid consumption (MME) during the first 24 hours after surgery between groups
Time frame
24 hours after block procedure2
OPIOID consumption during surgery
To compare the amount of opioid consumption oral MME consumption during surgery between groups
Time frame
Surgery length3
NRS pain score at 48 hours
To compare the NRS (0-10) pain score up to 48 hours
Time frame
Up to 48 hours after block procedure4
Worst pain score at 48 hours
To compare the worst pain experienced during up to 48-hours after surgery between groups
Time frame
Up to 48 hours after block procedureSponsors and contacts
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Source ClinicalTrials.gov