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Clinical Trials/NCT04951024
NCT04951024
Unknown
N/A

Comparison of Perioperative Analgesia Effectiveness Between Thoracolumbal Interfascial Plane Block With Erector Spinae Plane Block In Lumbar Posterior Decompression and Stabilization: A Study to Interleukin-6 and Interleukin-10 Plasma Concentration, Pain Scale, Total Opioid Consumption, and Cardiovascular Stability

Indonesia University1 site in 1 country40 target enrollmentMarch 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Lumbar Posterior Decompression
Sponsor
Indonesia University
Enrollment
40
Locations
1
Primary Endpoint
Change from baseline Interleukin-6 and Interleukin-10 at 6 hours after Lumbar Posterior Decompression and Stabilization
Last Updated
4 years ago

Overview

Brief Summary

This study aimed to found out The Comparison Of Perioperative Analgesia Effectiveness Between Thoracolumbal Interfascial Plane Block with Erector Spinae Plane Block In Lumbar Posterior Decompression and Stabilization.

Detailed Description

This is a double blind randomized controlled trial. Forty 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 group who will get Bilateral Thoracolumbal Interfascial Plane Block after general anesthesia and the second group will be the group who will get Bilateral Erector Spinae Plane Block after general anesthesia. After surgery, pain scale, time to first morphine dose, total morphine consumption in 24 hours, cardiovascular stability and adverse events will be recorded for both group.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
January 31, 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 - 65 years old
  • Patients schedule for elective posterior decompression and stabilization lumbar spine surgery
  • ASA I - III
  • Decompression and posterior stabilization's patients who didn't caused by infection or abscess

Exclusion Criteria

  • Patients who refuse to participate in this study
  • Body Mass Index \< 18,5 kg/m2 and \> 27,0 kg/m2
  • Patient with history of chronic opioid
  • Patient with coagulation disorder
  • Patient with cognitive disorders
  • Infection at the injection area

Outcomes

Primary Outcomes

Change from baseline Interleukin-6 and Interleukin-10 at 6 hours after Lumbar Posterior Decompression and Stabilization

Time Frame: Before surgery and 6 hours after surgery

Measure by ELISA

Secondary Outcomes

  • investigators will record total morphine dose needed in 24 hours(24 hours after surgery)

Study Sites (1)

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