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Enrolling by Invitation

NCT Number: NCT06910696

Erector Spinae Plane Block Versus Modified Thoracolumbar Interfascial Plane Block

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

Enrolling by Invitation

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Key information

Conditions

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

Age range

21 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of medicine,zagazig university Egypt Ext. 002 [email protected]

Zagazig, 44519, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Length of hospital stay

    Time frame: up to 1 weak postoperative.

    from the day of admission till discharge from hospital

Secondary outcomes

  1. The recovery time

    Time frame: up to 30 minutes postoperative.

    time from discontinuation of isoflurane to first response to verbal command

  2. The time of discharge

    Time frame: up to 2 hours postoperative.

    The time from arrival to the PACU to discharge to the ward

  3. 6 minutes walk test

    Time frame: 24 hours postoperative

    involves walking for 6 min on a 30 m walking path and measuring the distance

  4. Functional reach test

    Time frame: 24 hours postoperative

    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

  5. Time up and go test

    Time frame: 24 hours postoperative

    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

  6. Pain intensity

    Time frame: 30 minutes after the end of the surgery, as well as 3, 6, 12, and 24 hours postoperatively

    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)]

  7. Time to first call analgesia

    Time frame: 24 hours postoperative

  8. Total naluphine consumption

    Time frame: 24 hours post-operative

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2025
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.