Effectivity of Bilateral Transversus Thoracis Muscle Plane Block After Open Heart Surgery

Not Applicable

Completed

• Conditions: Interleukin-6; Cortisol
• Interventions: Procedure: Control; Procedure: Bilateral transversus thoracis muscle plane block

• Registration Number: NCT04544254
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study First Submitted: 2020-08-29
• Study First Submitted QC: 2020-09-03
• Study First Posted: 2020-09-10
• Study Start: 2020-10-15
• Primary Completion: 2021-03-15
• Study Completion: 2021-03-15
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-01
• Last Update Posted: 2021-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Needle will be put in the superficial skin on the same area as transversus thoracis muscle plane block area without any drugs injected into the injection area
Bilateral transversus thoracis muscle plane block	Bilateral transversus thoracis muscle plane block	Regional block will be performed after induction of anesthesia by anesthesiologist on duty who is not part of investigators for this study. The block will be performed in between intercostal space 4 and 5, lateral from sternum, with ultrasound guided

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
total morphine dose	24 hours	investigators will record total morphine dose needed in 24 hours
time to first morphine	24 hours	investigators will record time to first morphine dose after surgery

Trial Locations

Locations (1)

National General Hospital Dr. Cipto Mangunkusumo; 🇮🇩 Jakarta, DKI Jakarta, Indonesia