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

• Sponsor: Indonesia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05104203
• Collaborator: (none)
• Enrollment: 68
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.2
• Patients Per Site Per Month: 8.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Analgesia; Surgical Procedure, Unspecified	Procedure: Thoracolumbar Interfascial Plane block; Procedure: Modified Thorcolumbar Interfascial Plane block	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: 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
• Actual Study Start Date: Jan 21, 2021
• Actual Primary Completion Date: Mar 3, 2021
• Actual Study Completion Date: Sep 28, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Hemodynamic [approximately 15 minutes within surgery]

   Stability of Hemodynamics that needs the fentanyl addition

Secondary Outcome Measures

1. qNox Score [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: 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:

1. Obese patient, with BMI>30 kg.m2

2. Alergic to local anesthetics

3. Underweight patient with BMI <18,5 kg/m2"

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cipto Mangunkusumo Cental National Hospital	Jakarta	DKI Jakarta	Indonesia	10430

Sponsors and Collaborators

• Indonesia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aida Rosita Tantri, Doctor, Indonesia University
• ClinicalTrials.gov Identifier: NCT05104203
• Other Study ID Numbers: IndonesiaUAnes111
• First Posted: Nov 2, 2021
• Last Update Posted: Nov 2, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Aida Rosita Tantri, Doctor, Indonesia University: Erector Spinae Plane Block; opioid consumption; numerical rating scale; Interleukin 10; Interleukin 6; Thoracolumbal Interfascial Plane Block

Study Results

No Results Posted as of Nov 2, 2021