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CompletedNCT05104203Updated Nov 2, 2021

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

An interventional study of Thoracolumbar Interfascial Plane block and Modified Thorcolumbar Interfascial Plane block in Analgesia and Surgical Procedure, Unspecified, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-02.

Sponsored by Indonesia University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jan 2021, registered Jul 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Analgesia
  • Surgical Procedure, Unspecified

Keywords

  • Erector Spinae Plane Block
  • opioid consumption
  • numerical rating scale
  • Interleukin 10
  • Interleukin 6
  • Thoracolumbal Interfascial Plane Block
03

In context

Lead sponsor

Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  1. Obese patient, with BMI>30 kg.m2
  2. Alergic to local anesthetics
  3. Underweight patient with BMI \<18,5 kg/m2"
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
68 participants (actual)

Study arms

  • Active comparator
    Thoracolumbar Interfascial Plane block

    Patient will receive Thoracolumbar Interfascial Plane block

    Procedure: Thoracolumbar Interfascial Plane block · Procedure: Modified Thorcolumbar Interfascial Plane block

  • Experimental
    Modified Thoracolumbar Interfascial Plane block

    Patient will receive modified Thoracolumbar Interfascial Plane Block

    Procedure: Thoracolumbar Interfascial Plane block · Procedure: Modified Thorcolumbar Interfascial Plane block

Interventions

  • ProcedureThoracolumbar Interfascial Plane block

    Interfascial block done by injection between m. multifidus and m. longissimus

  • ProcedureModified Thorcolumbar Interfascial Plane block

    Injection of local anesthetics between m. longissimus and m. illiocostalis

06

What researchers measure

Primary outcomes

  1. Hemodynamic

    Stability of Hemodynamics that needs the fentanyl addition

    Time frame: approximately 15 minutes within surgery

Secondary outcomes

  1. 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

    Time frame: before induction of anesthesia, 15, 30, 45 minutes after the block was done.

07

Study locations

1 site
  • Cipto Mangunkusumo Cental National Hospital
    Jakarta, DKI Jakarta 10430, Indonesia
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05104203
Lead sponsor
Indonesia University
Responsible party
Aida Rosita Tantri (Doctor, Indonesia University) — Principal investigator
First posted
Nov 2, 2021
Start date
Jan 21, 2021
Primary completion
Mar 3, 2021
Completion
Sep 28, 2021
Last update
Nov 2, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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