Erector Spinae Plane Block Versus Modified Thoracolumbar Interfascial Plane Block

Erector Spinae Plane Block Versus Modified Thoracolumbar Interfascial Plane Block for Rapid Recovery and Rehabilitation After Lumber Discectomy: A Randomized Study

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Achievement of High-quality Analgesia, Rapid Recovery With Rehabilitation in Lumber Spine Discectomy
• Intervention / Treatment: Drug: Regional Anesthetic Injection; Drug: Regional Anesthetic Injection

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Egypt, 44519
    • faculty of medicine,zagazig university Egypt Ext. 002 K.Howida@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: • Control Group; Patients will receive standard analgesia (paracetamol 15mg/kg plus fentanyl 1ug/kg) iv.
Active Comparator: (mTLIP )Group; Patients will receive 20 mL of 0.25% bupivacaine on each side through Modified thoracolumbar interfascial block	Drug: 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; 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
Active Comparator: (ESPB) Group; Patients will receive 20 mL of 0.25% bupivacaine on each side through Erector spinae block	Drug: 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	from the day of admission till discharge from hospital	up to 1 weak postoperative.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The recovery time	time from discontinuation of isoflurane to first response to verbal command	up to 30 minutes postoperative.
The time of discharge	The time from arrival to the PACU to discharge to the ward	up to 2 hours postoperative.
6 minutes walk test	involves walking for 6 min on a 30 m walking path and measuring the distance	24 hours postoperative
Functional reach test	quantifies participants' dynamic in-place standing balance control to reach distance. The distance between the starting and maximal forward reach distance beyond the participant's arm length represents the reach distance and is recorded in centimeters	24 hours postoperative
Time up and go test	objective measure of functional disability that can be used to evaluate various activities such as standing, accelerating, walking, decelerating, and turning, which are often limited in patients with lumbar degenerative diseases	24 hours postoperative
Pain intensity	10-point NRS [(0 = no pain, 10 = worst imaginable pain), 1 - 3: Mild pain (nagging, annoying, slightly interfering with activities of daily living (ADLs), 4 - 6: Moderate pain (significantly interfering with ADLs, 7 - 10: Severe pain (disabling, unable to perform ADLs)]	30 minutes after the end of the surgery, as well as 3, 6, 12, and 24 hours postoperatively
Time to first call analgesia		24 hours postoperative
Total naluphine consumption		24 hours post-operative

Collaborators and Investigators

• Sponsor: Zagazig University

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: erector spinae plane block modified thoracolumbar interfascial plane block perioperative analgesia lumber spine discectomy?
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: ZU-IRB#1074/25-Feb-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No