Clinical trial NCT05103787: Impact of Bilateral Deep Parasternal Intercostal Plane Block on Intraoperative Opioid Consumption in Open Heart Surgery
Official title: Impact of Bilateral Deep Parasternal Intercostal Plane Block on Intraoperative Opioid Consumption in Open Heart Surgery: a Prospective, Double-blind Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Opioid Use
Keywords: regional anesthesia
intercostal plane block
opioid
open heart surgery
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total intraoperative fentanyl dose
timeFrame: intraoperatively
Secondary outcomes:
measure: Time to first intraoperative fentanyl
timeFrame: intraoperatively
measure: extubation time
timeFrame: Up to 72 hours after surgery
measure: opioid side effects
timeFrame: within 24 hours after surgery
measure: Intensive care unit length of stay
timeFrame: Up to 7 days after surgery
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Cental National Hospital
state: DKI Jakarta
city: Central Jakarta
country: Indonesia
facility: Universitas Indonesia
Study officials:
affiliation: Indonesia University
name: Aida Rosita R Tantri
role: PRINCIPAL_INVESTIGATOR
References:
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