Erector Spinae Plane Block Versus Modified Thoracolumbar Interfascial Plane Block

NCT06910696 | Enrolling By Invitation DMC

• 1 other identifier: ZU-IRB#1074/25-Feb-2025
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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

Keywords

erector spinae plane block modified thoracolumbar interfascial plane block perioperative analgesia lumber spine discectomy?

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  from the day of admission till discharge from hospital

  up to 1 weak postoperative.

Secondary Outcomes (8)

• The recovery time

  up to 30 minutes postoperative.

• The time of discharge

  up to 2 hours postoperative.

• 6 minutes walk test

  24 hours postoperative

• Functional reach test

  24 hours postoperative

• Time up and go test

  24 hours postoperative

Study Arms (3)

• Control Group

NO INTERVENTION

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

(mTLIP )Group

ACTIVE COMPARATOR

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

Drug: Regional Anesthetic Injection

(ESPB) Group

ACTIVE COMPARATOR

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

Drug: Regional Anesthetic Injection

Interventions

Regional Anesthetic Injection 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

(ESPB) Group

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

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

Zagazig, 44519, Egypt

Location

Related Links

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of anesthesia and surgical intensive care (Principal Investigator)

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 4, 2025
• Study Start: April 11, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

EG (1)