TLIP Block Versus Modified TLIP Block for Posterior Decompression and Stabilization Surgery

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

Perioperative Analgesia Efectivity of Thoracolumbar Interfascial Plane Block Compared Modified Thoracolumbar Interfascial Plane Block in Posterior Lumbal Decompression and Stabilization: Research in Intraoperative Hemodynamic and qNox and Total Morfin Comsumption and Postoperative IL-6 Concentration

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

68

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 Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 10430
        • Cipto Mangunkusumo Cental National Hospital

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Thoracolumbar Interfascial Plane block
Patient will receive Thoracolumbar Interfascial Plane block
Procedure: Thoracolumbar Interfascial Plane block
Interfascial block done by injection between m. multifidus and m. longissimus
Procedure: Modified Thorcolumbar Interfascial Plane block
Injection of local anesthetics between m. longissimus and m. illiocostalis
Experimental: Modified Thoracolumbar Interfascial Plane block
Patient will receive modified Thoracolumbar Interfascial Plane Block
Procedure: Thoracolumbar Interfascial Plane block
Interfascial block done by injection between m. multifidus and m. longissimus
Procedure: Modified Thorcolumbar Interfascial Plane block
Injection of local anesthetics between m. longissimus and m. illiocostalis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodynamic
Time Frame: approximately 15 minutes within surgery
Stability of Hemodynamics that needs the fentanyl addition
approximately 15 minutes within surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
qNox Score
Time Frame: before induction of anesthesia, 15, 30, 45 minutes after the block was done.
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.

Collaborators and Investigators

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

Sponsor

Indonesia University

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)

January 21, 2021

Primary Completion (Actual)

March 3, 2021

Study Completion (Actual)

September 28, 2021

Study Registration Dates

First Submitted

July 21, 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

  • IndonesiaUAnes111

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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