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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05104203
Other study ID # IndonesiaUAnes111
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 21, 2021
Est. completion date September 28, 2021

Study information

Verified date October 2021
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aimed to compare the analgesia effectivity of TLIP and modified TLIP block in Posterior Lumbar Decompression and Stabilization Surgery Perioperatively.


Description:

This study aimed to compare the analgesia effectivity of TLIP and modified TLIP block in Posterior Lumbar Decompression and Stabilization Surgery. Intraoperatively, total fentanyl consumption, hemodynamic, and mean qNox Score was recorded. And Postoperatively, the patient was given the PCA, and total morphine consumption was assessed.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date September 28, 2021
Est. primary completion date March 3, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Patients undergo thoracolumbar Decompression and Stabilization Surgery 2. Age between 18-65 years old 3. BMI >18,5 kg.m2, and BMI< 30 kg/m2 4. ASA 1-3 5. No contraindications for the patients to do the Block, and the patients agree and signed the informed consent before the procedure was done Exclusion Criteria: 1. Obese patient, with BMI>30 kg.m2 2. Alergic to local anesthetics 3. Underweight patient with BMI <18,5 kg/m2"

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Thoracolumbar Interfascial Plane block
Interfascial block done by injection between m. multifidus and m. longissimus
Modified Thorcolumbar Interfascial Plane block
Injection of local anesthetics between m. longissimus and m. illiocostalis

Locations

Country Name City State
Indonesia Cipto Mangunkusumo Cental National Hospital Jakarta DKI Jakarta

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hemodynamic Stability of Hemodynamics that needs the fentanyl addition approximately 15 minutes within surgery
Secondary qNox Score qNox score were taken before induction of anesthesia, 15, 30 and 45 minutes after the block done. the mean of 15,30 and 45 minutes qNox score was assesed before induction of anesthesia, 15, 30, 45 minutes after the block was done.
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