NCT05104203

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
Last Updated

November 2, 2021

Status Verified

October 1, 2021

Enrollment Period

1 month

First QC Date

July 21, 2021

Last Update Submit

October 31, 2021

Conditions

AnalgesiaSurgical Procedure, Unspecified

Keywords

Erector Spinae Plane Blockopioid consumptionnumerical rating scaleInterleukin 10Interleukin 6Thoracolumbal Interfascial Plane Block

Outcome Measures

Primary Outcomes (1)

  • Hemodynamic

    Stability of Hemodynamics that needs the fentanyl addition

    approximately 15 minutes within surgery

Secondary Outcomes (1)

  • qNox Score

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

Study Arms (2)

Thoracolumbar Interfascial Plane block

ACTIVE COMPARATOR

Patient will receive Thoracolumbar Interfascial Plane block

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

Modified Thoracolumbar Interfascial Plane block

EXPERIMENTAL

Patient will receive modified Thoracolumbar Interfascial Plane Block

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

Interventions

Thoracolumbar Interfascial Plane blockPROCEDURE

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

Modified Thoracolumbar Interfascial Plane blockThoracolumbar Interfascial Plane block
Modified Thorcolumbar Interfascial Plane blockPROCEDURE

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

Modified Thoracolumbar Interfascial Plane blockThoracolumbar Interfascial Plane block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergo thoracolumbar Decompression and Stabilization Surgery
  • Age between 18-65 years old
  • BMI \>18,5 kg.m2, and BMI\< 30 kg/m2
  • ASA 1-3
  • No contraindications for the patients to do the Block, and the patients agree and signed the informed consent before the procedure was done

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 21, 2021

First Posted

November 2, 2021

Study Start

January 21, 2021

Primary Completion

March 3, 2021

Study Completion

September 28, 2021

Last Updated

November 2, 2021

Record last verified: 2021-10

Locations

ID(1)