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Clinical Trials/NCT05103787
NCT05103787
Unknown
Not Applicable

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

Indonesia University2 sites in 1 country30 target enrollmentOctober 4, 2021
ConditionsOpioid Use

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opioid Use
Sponsor
Indonesia University
Enrollment
30
Locations
2
Primary Endpoint
Total intraoperative fentanyl dose
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 4, 2021
End Date
July 4, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aida Rosita Tantri

Doctor

Indonesia University

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

Outcomes

Primary Outcomes

Total intraoperative fentanyl dose

Time Frame: intraoperatively

Total intraoperative fentanyl dose will be calculated after surgery

Secondary Outcomes

  • Time to first intraoperative fentanyl(intraoperatively)
  • extubation time(Up to 72 hours after surgery)
  • opioid side effects(within 24 hours after surgery)
  • Intensive care unit length of stay(Up to 7 days after surgery)

Study Sites (2)

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