Impact of Bilateral Deep Parasternal Intercostal Plane Block on Intraoperative Opioid Consumption in Open Heart Surgery

Study Overview
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Brief Summary
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This study aims to assess the impact of bilateral deep parasternal intercostal plane block on intraoperative opioid consumption in open heart surgery

Detailed Description
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High-dose opioid is associated with various side effects such as nausea, vomiting, urinary retention, and respiratory depression. The neuraxial block (intrathecal, epidural) and peripheral nerve block are regional anesthesia techniques which have the potential to reduce intraoperative opioid consumption. The deep parasternal intercostal plane block is fascial plane block which intended to block anterior cutaneous branch of intercostal nerves. This study is a double-blind randomized controlled trial. Thirty subjects will be recruited with consecutive sampling method. Eligible subjects with signed informed consent will be randomized into two groups. The first group is the treatment group who will receive bilateral deep parasternal intercostal plane block after induction of anesthesia and the second group will be the control group who will not receive any regional anesthesia. After surgery, extubation time, adverse event (nausea, vomiting), and intensive care unit length of stay will be recorded for both groups.

Official Title
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Impact of Bilateral Deep Parasternal Intercostal Plane Block on Intraoperative Opioid Consumption in Open Heart Surgery: a Prospective, Double-blind Randomized Controlled Study

Conditions
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Opioid Use

Intervention / Treatment
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* Procedure: deep parasternal intercostal plane block
* Procedure: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-70 years old Elective open-heart surgery with median sternotomy approach Exclusion Criteria: Patient who refuses to participate Patient with local infection in the block area Patient with chronic pain Patient with history of chronic analgesics use Patient who is contraindicated for local anesthetics Patient with cognitive disorder Patient with severe psychiatric disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: deep parasternal plane block<br>Subjects will receive bilateral deep parasternal intercostal plane block after induction of anesthesia. | Procedure: deep parasternal intercostal plane block<br>* Twenty milliliters of 0.25% bupivacaine will be placed bilaterally in the fascial plane between internal intercostal muscle and transversus thoracis muscle at intercostal space 4 or 5, lateral from sternum, with ultrasound guidance using high-frequency linear transducer.<br>Procedure: control<br>* Skin puncture with needle will be performed on the same location as the treatment group without administration of local anesthetics.<br>|
| Placebo Comparator: control<br>subjects will receive skin puncture with needle on the same location as the treatment group without administration of local anesthetics after induction of anesthesia, | Procedure: deep parasternal intercostal plane block<br>* Twenty milliliters of 0.25% bupivacaine will be placed bilaterally in the fascial plane between internal intercostal muscle and transversus thoracis muscle at intercostal space 4 or 5, lateral from sternum, with ultrasound guidance using high-frequency linear transducer.<br>Procedure: control<br>* Skin puncture with needle will be performed on the same location as the treatment group without administration of local anesthetics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total intraoperative fentanyl dose | Total intraoperative fentanyl dose will be calculated after surgery | intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first intraoperative fentanyl | Investigators will record time to first fentanyl dose after incision | intraoperatively | 
| extubation time | Investigators will record time to extubation after surgery | Up to 72 hours after surgery | 
| opioid side effects | Incidence of nausea and vomiting | within 24 hours after surgery | 
| Intensive care unit length of stay | Investigators will record total time from intensive care unit admission until patient transferred to surgical wars | Up to 7 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intercostal plane block, regional anesthesia, opioid, open heart surgery