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Clinical Trials/NCT04544254
NCT04544254
Completed
N/A

Effectivity of Bilateral Transversus Thoracis Muscle Plane Block to Reduce Pain and Stress Response After Open Heart Surgery: A Study to Interleukin-6 and Cortisol Plasma Concentration, Total Opioid Dose, and Time to First Opioid

Indonesia University1 site in 1 country32 target enrollmentOctober 15, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Interleukin-6
Sponsor
Indonesia University
Enrollment
32
Locations
1
Primary Endpoint
Interleukin-6 plasma concentration
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This Study aimed to assess The Effectivity of Bilateral Transversus Thoracis Muscle Plane Block to Reduce Pain and Stress Response After Open Heart Surgery

Detailed Description

This is a double blind randomized controlled trial. Thirty-two subject will be recruited with non-probability consecutive sampling method. Subjects who meet all inclusion criteria and do not have exclusion criteria will be asked to sign the informed consent form before included in this study. Subjects will be randomized into two groups. The first group is the treatment group who will get Bilateral Transversus Thoracis Muscle Plane Block after induction of anesthesia and the second group will be the control group who will not get any regional block during surgery. After surgery, time to first morphine dose, total morphine consumption in 24 hours, extubation time, and adverse events will be recorded for both group.

Registry
clinicaltrials.gov
Start Date
October 15, 2020
End Date
March 15, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aida Rosita Tantri

Principal Investigator

Indonesia University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Interleukin-6 plasma concentration

Time Frame: 48 hours

Interleukin-6 plasma concentration will be measured 3 times, before surgery, 24 hours after surgery, and 48 hours after surgery

Cortisol plasma concentration

Time Frame: 48 hours

cortisol plasma concentration will be measured 3 times, before surgery, 24 hours after surgery, and 48 hours after surgery

Secondary Outcomes

  • total morphine dose(24 hours)
  • time to first morphine(24 hours)

Study Sites (1)

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