Ultrasound Guided Erector Spinae Block vs Thoracolumbar Interfascial Plane Block

NCT05596227 | Completed

• 1 other identifier: 35634/8/22
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of this Study will be to compare Ultrasound guided erector spinae block vs thoracolumbar interfascial plane (TLIP) block in lumbar spine surgeries.

Conditions

Analgesia; Lumbar Spine Disease

Outcome Measures

Primary Outcomes (1)

• Total postoperative fentanyl requirements

  Total postoperative fentanyl requirements

  24 hours

Secondary Outcomes (3)

• pain score at rest and during movement

  24 hours

• time of first postoperative analgesic request

  24 hours

• opioids side effects

  24 hours

Study Arms (3)

control group

PLACEBO COMPARATOR

Patients will not recieve either erector spinae plane block nor thoracolumbar interfascial plane block

Drug: Propofol; Drug: Fentanyl; Drug: Rocuronium; Drug: Sevoflurane

Erector spinae plane block

ACTIVE COMPARATOR

Patients will recieve ultrasound guided erector spinae plane block.

Drug: Propofol; Drug: Fentanyl; Drug: Rocuronium; Drug: Sevoflurane; Other: Erector spinae plane block

Thoracolumbar interfascial plane block

ACTIVE COMPARATOR

Patients will recieve ultrasound guided thoracolumbar interfascial plane block.

Drug: Propofol; Drug: Fentanyl; Drug: Rocuronium; Drug: Sevoflurane; Other: Thoracolumbar interfascial plane block

Interventions

Propofol DRUG

Induction of anesthesia will be by IV propofol (2-2.5 mg/kg)

Also known as: Intravenous anesthesia

Erector spinae plane block; Thoracolumbar interfascial plane block; control group

Fentanyl DRUG

Fentanyl will be injected during the induction of anesthesia (1-1.5 mg/kg)

Also known as: Intravenous narcotic

Erector spinae plane block; Thoracolumbar interfascial plane block; control group

Rocuronium DRUG

Rocuronium will be injected during induction of anesthesia (0.6 mg/ kg)

Also known as: Muscle relaxant

Erector spinae plane block; Thoracolumbar interfascial plane block; control group

Sevoflurane DRUG

Sevoflurane inhalationa anesthesia will be used for maintainance of anesthesia

Also known as: Inhalational anesthetic

Erector spinae plane block; Thoracolumbar interfascial plane block; control group

Erector spinae plane block OTHER

In the ESPB group, the probe will be placed in the parasagittal plane at the level of the L3 vertebrae. The spinous process will be visualized, and the probe will move 3 cm laterally from the midline. The erector spinae muscle will be visualized above the transverse process. The needle will be punctured in the craniocaudal direction using the in-plane technique. The needle will be directed superior to the transverse process . Then, 2 mL normal saline solution was injected into the deep fascia of the erector spinae muscle to confirm the proper injection site. After ensuring the location of the needle, 20 mL of 0.25% bupivacaine was administered. The same ESPB procedure will be performed on the other side. In total, 40 mL of 0.25% bupivacaine was administered.

Erector spinae plane block

Thoracolumbar interfascial plane block OTHER

In the mTLIP group, the probe will be placed vertically at the L3 vertebrae level. The spinous process and the interspinous muscles (i.e., multifidus, longissimus, and iliocostalis) will be visualized as the anatomic guide points. The probe will move laterally to identify the longissimus and iliocostalis muscles. The needle will be inserted between the longissimus and iliocostalis in the medial-to-lateral direction using the in-plane technique. After confirming the location of the needle, 20 mL of 0.25% bupivacaine was administered. The same mTLIP procedure will be performed on the opposite side. In total, 40 mL of 0.25% bupivacaine will be administered.

Thoracolumbar interfascial plane block

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing lumbar spine surgery
• American Society of Anesthesiologists (ASA) classification as ASA I-II.

You may not qualify if:

• coagulation abnormality
• anticoagulant treatment,
• allergies to local anesthetics,
• skin infections at the site of block area,
• pregnancy or lactation,
• refusal to participate in the study.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Mona Mohamed Mogahed

Tanta, Elgharbia, 31511, Egypt

Location

MeSH Terms

Conditions

Agnosia; Spinal Diseases

Interventions

Propofol; Anesthesia, Intravenous; Fentanyl; Rocuronium; Sevoflurane

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Anesthesia; Anesthesia and Analgesia; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 27, 2022
• Study Start: October 20, 2022
• Primary Completion: September 20, 2024
• Study Completion: September 20, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)