NCT04951024

Brief Summary

This study aimed to found out The Comparison Of Perioperative Analgesia Effectiveness Between Thoracolumbal Interfascial Plane Block with Erector Spinae Plane Block In Lumbar Posterior Decompression and Stabilization.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 6, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

July 6, 2021

Status Verified

June 1, 2021

Enrollment Period

10 months

First QC Date

June 26, 2021

Last Update Submit

July 2, 2021

Conditions

Lumbar Posterior Decompression

Keywords

Thoracolumbal Interfascial Plane BlockErector Spinae Plane BlockLumbar Posterior Decompression and Stabilization

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Interleukin-6 and Interleukin-10 at 6 hours after Lumbar Posterior Decompression and Stabilization

    Measure by ELISA

    Before surgery and 6 hours after surgery

Secondary Outcomes (1)

  • investigators will record total morphine dose needed in 24 hours

    24 hours after surgery

Study Arms (2)

Thoracolumbar interfacial plane (TLIP) Block

EXPERIMENTAL

Thoracolumbar interfacial plane (TLIP) Block will be performed after induction of anesthesia by anesthesiologist who is not part of investigators for this study. Bilateral 20 ml 0.25 % Bupivacaine injected between multifidus and longissimus muscle with Ultrasound guidance.

Procedure: Thoracolumbar interfacial plane (TLIP) BlockProcedure: Erector Spinae Plane (ESP) Block

Erector Spinae Plane (ESP) Block

ACTIVE COMPARATOR

Erector Spinae Plane (ESP) Block will be performed after induction of anesthesia by anesthesiologist who is not part of investigators for this study. Bilateral 20 ml 0.25 % Bupivacaine injected between the erector spinae muscles and transverse process with Ultrasound guidance

Procedure: Thoracolumbar interfacial plane (TLIP) BlockProcedure: Erector Spinae Plane (ESP) Block

Interventions

Thoracolumbar interfacial plane (TLIP) BlockPROCEDURE

TLIP Block: Bilateral 20 ml 0.25 % Bupivacaine injected between multifidus and longissimus muscle with Ultrasound guidance.

Erector Spinae Plane (ESP) BlockThoracolumbar interfacial plane (TLIP) Block
Erector Spinae Plane (ESP) BlockPROCEDURE

ESP Block: Bilateral 20 ml 0.25 % Bupivacaine injected between the erector spinae muscles and transverse process with Ultrasound guidance.

Erector Spinae Plane (ESP) BlockThoracolumbar interfacial plane (TLIP) Block

Eligibility Criteria

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

You may qualify if:

  • Age 18 - 65 years old
  • Patients schedule for elective posterior decompression and stabilization lumbar spine surgery
  • ASA I - III
  • Decompression and posterior stabilization's patients who didn't caused by infection or abscess

You may not qualify if:

  • Patients who refuse to participate in this study
  • Body Mass Index \< 18,5 kg/m2 and \> 27,0 kg/m2
  • Patient with history of chronic opioid
  • Patient with coagulation disorder
  • Patient with cognitive disorders
  • Infection at the injection area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

RECRUITING

Related Publications (1)

  • Tantri AR, Rahmi R, Marsaban AHM, Satoto D, Rahyussalim AJ, Sukmono RB. Comparison of postoperative IL-6 and IL-10 levels following Erector Spinae Plane Block (ESPB) and classical Thoracolumbar Interfascial Plane (TLIP) block in a posterior lumbar decompression and stabilization procedure: a randomized controlled trial. BMC Anesthesiol. 2023 Jan 10;23(1):13. doi: 10.1186/s12871-023-01973-w.

    PMID: 36624374DERIVED

MeSH Terms

Interventions

Dental OcclusionParapsychology

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaBehavioral SciencesBehavioral Disciplines and Activities

Central Study Contacts

Aida Rosita R Tantri

CONTACT

0213143336aidatantri@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 26, 2021

First Posted

July 6, 2021

Study Start

March 1, 2021

Primary Completion

December 31, 2021

Study Completion

January 31, 2022

Last Updated

July 6, 2021

Record last verified: 2021-06

Locations

ID(1)