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

October 31, 2021 updated by: Aida Rosita Tantri, Indonesia University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: A A G Putra Semara, doctor
  • Phone Number: 0213143336

Study Locations

  • Indonesia
      • Central Jakarta, Indonesia, 10430
        • Recruiting
        • Universitas Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 10430
        • Recruiting
        • Cipto Mangunkusumo Cental National Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: deep parasternal plane block
Subjects will receive bilateral deep parasternal intercostal plane block after induction of anesthesia.
Procedure: deep parasternal intercostal plane block
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.
Procedure: control
Skin puncture with needle will be performed on the same location as the treatment group without administration of local anesthetics.
Placebo Comparator: 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,
Procedure: deep parasternal intercostal plane block
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.
Procedure: control
Skin puncture with needle will be performed on the same location as the treatment group without administration of local anesthetics.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Aida Rosita R Tantri, Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2021

Primary Completion (Anticipated)

April 4, 2022

Study Completion (Anticipated)

July 4, 2022

Study Registration Dates

First Submitted

September 27, 2021

First Submitted That Met QC Criteria

October 31, 2021

First Posted (Actual)

November 2, 2021

Study Record Updates

Last Update Posted (Actual)

November 2, 2021

Last Update Submitted That Met QC Criteria

October 31, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IndonesiaUAnes119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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