Comparison of Quadro Iliac vs Erector Spinae Plane Block on Postoperative Pain and Opioid Use in Lumbar Discectomies

NCT06656507 | Completed

• 1 other identifier: qip-esp/ldh
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

This multicenter, randomized, controlled study aims to compare the analgesic efficacy of Quadro Iliac Plane Block (QIPB) and Erector Spinae Plane (ESP) Block in lumbar vertebra surgeries. The study will evaluate postoperative pain management, opioid consumption, side effects, hospital stay duration, and patient satisfaction. Patients scheduled for single-level lumbar disk herniation surgery will be randomized to receive either the QIPB or ESP block before awakening from anesthesia. Pain scores will be measured at multiple postoperative time points, and opioid consumption will be monitored using patient-controlled analgesia (PCA). The study seeks to identify the most effective and safe method for postoperative pain management in lumbar surgeries.

Conditions

Postoperative Pain; Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (1)

• NRS Score

  Postoperative pain assessed by numerical rating scale (NRS) (0-10)

  24 hours

Secondary Outcomes (3)

• PCA

  24 hours

• Rescue analgesia

  24 hours

• Side effects

  24 hours

Study Arms (2)

Quadro Iliac Plane Block (QIPB) Arm

EXPERIMENTAL

Patients in this arm will receive the Quadro Iliac Plane Block (QIPB) before awakening from lumbar vertebra surgery. Patients in this arm will receive the Quadro Iliac Plane Block (QIPB) before awakening from lumbar vertebra surgery. The patient will be placed in a prone position, and a low-frequency convex ultrasound transducer (2-6 MHz) will be used. The transducer will be placed in the midline at the L3 level in the transverse plane to identify the spinal process. After lateral movement, the transverse process within the erector spinae muscle will be visualized. The transducer will then be rotated to the parasagittal plane and moved caudally to identify the attachment of the Quadratus Lumborum Muscle (QLM) to the iliac crest. A 22G x 100 mm peripheral nerve block needle (Stimuplex® Ultra 360®, B-Braun, USA) will be advanced under ultrasound guidance, and 50 mg (0.25%) bupivacaine will be injected bilaterally into the fascia below the QLM.

Procedure: Quadro Iliac Plane Block (QIPB)

Erector Spinae Plane Block (ESP) Arm

EXPERIMENTAL

Patients in this arm will receive the Erector Spinae Plane Block (ESP) before awakening from lumbar vertebra surgery. Patients in this arm will receive the Erector Spinae Plane Block (ESP) before awakening from lumbar vertebra surgery. A linear ultrasound probe will be placed transversely over the L3 vertebra to visualize the transverse process. A block needle (Stimuplex® Ultra 360®, B-Braun, USA) will be advanced under ultrasound guidance until it contacts the transverse process. After withdrawing the needle by 1 mm, 50 mg (0.25%) bupivacaine will be injected bilaterally.

Procedure: Erector Spinae Plane Block (ESP)

Interventions

Quadro Iliac Plane Block (QIPB) PROCEDURE

The Quadro Iliac Plane Block (QIPB) will be performed pre-awakening in patients undergoing lumbar vertebra surgeries. Using a low-frequency convex ultrasound transducer (2-6 MHz), the spinal process will be identified at the L3 level in a prone-positioned patient. The transducer will be moved laterally to locate the transverse process within the erector spinae muscle and then rotated to the parasagittal plane to identify the Quadratus Lumborum Muscle (QLM) attachment to the iliac crest. A 22G x 100 mm block needle will be advanced under ultrasound guidance, and 50 mg (0.25%) bupivacaine will be injected bilaterally into the fascia beneath the QLM. This technique is designed to provide effective postoperative pain control by blocking the nerves in the quadratus lumborum plane.

Quadro Iliac Plane Block (QIPB) Arm

Erector Spinae Plane Block (ESP) PROCEDURE

The Erector Spinae Plane Block (ESP) will also be performed pre-awakening. A linear ultrasound probe will be placed transversely at the level of the L3 vertebra to visualize the transverse process. A block needle will be advanced under ultrasound guidance until it touches the transverse process, after which the needle will be withdrawn 1 mm. Fifty milligrams (0.25%) bupivacaine will then be administered bilaterally. The ESP block aims to provide postoperative analgesia by blocking sensory nerves in the erector spinae plane.

Erector Spinae Plane Block (ESP) Arm

Eligibility Criteria

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

You may qualify if:

• Patients aged 18 to 65 years.
• ASA physical status classification I-III.
• Patients scheduled for single-level lumbar disk herniation surgery.
• No history of bleeding diathesis.
• No history of anticoagulant use.
• No known allergies to the medications used in the study (e.g., bupivacaine).
• No history of neuropathic diseases.
• Patients who have provided informed consent to participate in the study.

You may not qualify if:

• Patients younger than 18 or older than 65 years.
• ASA physical status classification IV or higher.
• Patients with a history of coagulopathy or bleeding disorders.
• Patients with a history of chronic opioid use or substance abuse.
• Patients with allergies to local anesthetics (e.g., bupivacaine).
• Patients with significant neuropathic conditions or central nervous system disorders.
• Patients with any contraindication to regional anesthesia.
• Pregnant or breastfeeding women.
• Patients unable to provide informed consent.

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (2)

Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

Istanbul, 34303, Turkey (Türkiye)

Location

Zincirlikuyu Medicana Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: This study employs a Double-Blind masking approach to minimize bias. Both the patients and the healthcare providers (including postoperative care staff) will be unaware of which block (Quadro Iliac Plane Block or Erector Spinae Plane Block) was administered. The anesthesiologists performing the blocks will be informed of the assigned intervention but will not participate in postoperative care or outcome assessment. The outcome assessors, who will evaluate pain scores, opioid consumption, and other outcomes, will also be blinded to the group allocation to ensure unbiased data collection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: anesthesiology and reanimation specialist

Model Details: This study follows a Parallel Assignment model where eligible patients undergoing lumbar vertebra surgeries will be randomized into one of two groups. One group will receive the Quadro Iliac Plane Block (QIPB), while the other group will receive the Erector Spinae Plane (ESP) Block. Both interventions will be administered pre-awakening following surgery, with each group receiving only their assigned block. The groups will be assessed independently for postoperative pain control, opioid consumption, side effects, and overall patient satisfaction. This parallel approach ensures that each group's treatment and outcomes are evaluated without crossover, allowing for a direct comparison of the two regional anesthesia techniques.

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 24, 2024
• Study Start: November 1, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 16, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

TU (2)