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

Not Applicable

• Conditions: Opioid Use
• Interventions: Procedure: deep parasternal intercostal plane block; Procedure: control

• Registration Number: NCT05103787
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study First Submitted: 2021-09-27
• Status Verified: 2021-10
• Study Start: 2021-10-04
• Study First Submitted QC: 2021-10-31
• Last Update Submitted: 2021-10-31
• Study First Posted: 2021-11-02
• Last Update Posted: 2021-11-02
• Primary Completion: 2022-04-04
• Study Completion: 2022-07-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	deep parasternal intercostal plane block	subjects will receive skin puncture with needle on the same location as the treatment group without administration of local anesthetics after induction of anesthesia,
control	control	subjects will receive skin puncture with needle on the same location as the treatment group without administration of local anesthetics after induction of anesthesia,
deep parasternal plane block	control	Subjects will receive bilateral deep parasternal intercostal plane block after induction of anesthesia.
deep parasternal plane block	deep parasternal intercostal plane block	Subjects will receive bilateral deep parasternal intercostal plane block after induction of anesthesia.

Primary Outcome Measures

Name	Time	Method
Total intraoperative fentanyl dose	intraoperatively	Total intraoperative fentanyl dose will be calculated after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Cipto Mangunkusumo Cental National Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia

Universitas Indonesia; 🇮🇩 Central Jakarta, Indonesia