Thoracolumbal Interfascial Plane Block Versus Erector Spinae Plane Block for Lumbar Posterior Decompression Stabilization

Not Applicable

• Conditions: Lumbar Posterior Decompression
• Interventions: Procedure: Thoracolumbar interfacial plane (TLIP) Block; Procedure: Erector Spinae Plane (ESP) Block

• Registration Number: NCT04951024
• Lead Sponsor: Indonesia University

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.

Detailed Description

This is a double blind randomized controlled trial. Forty subject will be recruited with non-probability consecutive sampling method. Subjects who meet all inclusion criteria and do not have exclusion criteria will be asked to sign the informed consent form before included in this study. Subjects will be randomized into two groups. The first group is the group who will get Bilateral Thoracolumbal Interfascial Plane Block after general anesthesia and the second group will be the group who will get Bilateral Erector Spinae Plane Block after general anesthesia. After surgery, pain scale, time to first morphine dose, total morphine consumption in 24 hours, cardiovascular stability and adverse events will be recorded for both group.

Study Timeline

• Study Start: 2021-03-01
• Status Verified: 2021-06
• Study First Submitted: 2021-06-26
• Study First Submitted QC: 2021-07-02
• Last Update Submitted: 2021-07-02
• Study First Posted: 2021-07-06
• Last Update Posted: 2021-07-06
• Primary Completion: 2021-12-31
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erector Spinae Plane (ESP) Block	Thoracolumbar interfacial plane (TLIP) Block	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
Thoracolumbar interfacial plane (TLIP) Block	Thoracolumbar interfacial plane (TLIP) Block	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.
Thoracolumbar interfacial plane (TLIP) Block	Erector Spinae Plane (ESP) Block	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.
Erector Spinae Plane (ESP) Block	Erector Spinae Plane (ESP) Block	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

Primary Outcome Measures

Name	Time	Method
Change from baseline Interleukin-6 and Interleukin-10 at 6 hours after Lumbar Posterior Decompression and Stabilization	Before surgery and 6 hours after surgery	Measure by ELISA

Secondary Outcome Measures

Name	Time	Method
investigators will record total morphine dose needed in 24 hours	24 hours after surgery	investigators will record time to first morphine dose after surgery

Trial Locations

Locations (1)

Cipto Mangunkusumo Cental National Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia