Erector Spinae Plane Block Versus Modified Thoracolumbar Interfascial Plane Block

NCT ID: NCT06910696

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-11
• Study Completion Date: 2025-12-01

Brief Summary

the purpose of this study is to compare of better postoperative analgesia following lumber spine discectomy

Conditions

Achievement of High-quality Analgesia, Rapid Recovery With Rehabilitation in Lumber Spine Discectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

• Control Group

Patients will receive standard analgesia (paracetamol 15mg/kg plus fentanyl 1ug/kg) iv.

Group Type: NO_INTERVENTION

No interventions assigned to this group

(mTLIP )Group

Patients will receive 20 mL of 0.25% bupivacaine on each side through Modified thoracolumbar interfascial block

Group Type: ACTIVE_COMPARATOR

Regional Anesthetic Injection

Intervention Type: DRUG

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 probewill be moved laterally to identify the longissimus and iliocostalis muscles . The needlewill 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 will be administered. The same mTLIP procedure will be performed on the opposite side. In total, 40 mL of 0.25% bupivacaine will be administered

(ESPB) Group

Patients will receive 20 mL of 0.25% bupivacaine on each side through Erector spinae block

Group Type: ACTIVE_COMPARATOR

Regional Anesthetic Injection

Intervention Type: DRUG

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 was moved 3 cm laterally from the midline. The erector spinae musclewill 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 will be 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 will be administered. The same ESPB procedure will be performed on the other side. In total, 40 mL of 0.25% bupivacaine was administered

Interventions

Regional Anesthetic Injection

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 was moved 3 cm laterally from the midline. The erector spinae musclewill 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 will be 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 will be administered. The same ESPB procedure will be performed on the other side. In total, 40 mL of 0.25% bupivacaine was administered

Intervention Type: DRUG

Regional Anesthetic Injection

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 probewill be moved laterally to identify the longissimus and iliocostalis muscles . The needlewill 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 will be administered. The same mTLIP procedure will be performed on the opposite side. In total, 40 mL of 0.25% bupivacaine will be administered

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Written informed consent from the patient.
• Physical status: ASA 1& II.
• BMI = (25-30 kg/m2).
• Type of operation: elective Lumbar discectomy .

Exclusion Criteria

• Altered mental state.
• Patients with known history of allergy to study drugs.
• Advanced hepatic, renal, cardiovascular, and respiratory diseases.
• Patients with chronic pain.
• Patients receiving anticoagulants.
• Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy, or septic focus at site of injection.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Marwa Mohamed Medhat

assistant professor of anesthesia and surgical intensive care (Principal Investigator)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

faculty of medicine,zagazig university Egypt Ext. 002 K.Howida@yahoo.com

Zagazig, , Egypt

Countries

Egypt

Related Links

https://pubmed.ncbi.nlm.nih.gov/29318534/

https://pubmed.ncbi.nlm.nih.gov/29318534/

Other Identifiers

ZU-IRB#1074/25-Feb-2025

Identifier Type: -

Identifier Source: org_study_id