NCT06851533

Brief Summary

Lumbar microdiscectomy is a commonly used surgical procedure for treating herniated discs. Effective postoperative analgesia is crucial for early mobilization and functional recovery. Uncontrolled postoperative pain can delay recovery, increase the risk of opioid dependence, and lead to respiratory complications. Although opioid analgesics effectively reduce pain, they can cause side effects such as nausea, vomiting, respiratory depression, and dependency. Therefore, non-opioid analgesic methods are preferred for patient safety and comfort. Recently, regional anesthesia techniques such as the Thoracolumbar Interfascial Plane (TLIP) block and the Quadro Iliac Plane Block have been introduced for postoperative pain management in lumbar surgeries. However, there are not enough studies comparing the superiority of these two methods. Study Objective: The primary aim of this study is to evaluate the effects of ultrasound-guided TLIP and Quadro Iliac Plane Blocks on postoperative opioid consumption after lumbar microsurgery. The secondary aim is to compare opioid-related side effects (such as nausea, vomiting, respiratory depression, etc.) and postoperative NRS pain scores between the groups.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

March 10, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2026

Completed
Last Updated

December 8, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

February 24, 2025

Last Update Submit

December 1, 2025

Conditions

Keywords

Postoperative painUltrasound-guided nerve block

Outcome Measures

Primary Outcomes (1)

  • tramadol consumption

    Total tramadol consumption (mg) in the first 24 hours after surgery.

    first 24 hours after the operation

Secondary Outcomes (2)

  • NRS (Numerical Rating Scale) pain scores

    first 24 hours after the operation

  • opioid-related side effects (such as nausea, vomiting, respiratory depression)

    first 24 hours after the operation

Study Arms (3)

No Block (Control Group)

ACTIVE COMPARATOR

Patients receive standard perioperative analgesia without any additional regional block.

Procedure: Standard Analgesia (No Block)

TLIP Block

EXPERIMENTAL

Patients receive the Thoracolumbar Interfascial Plane (TLIP) block in addition to standard perioperative analgesia.

Procedure: Thoracolumbar Interfascial Plane (TLIP) Block

Quadro Iliac Plane Block

EXPERIMENTAL

Patients receive the Quadro Iliac Plane Block in addition to standard perioperative analgesia.

Procedure: Quadro Iliac Plane Block

Interventions

Participants receive standard perioperative analgesia (including intravenous paracetamol/tramadol), but no additional regional block is applied.

No Block (Control Group)

In addition to standard perioperative analgesia, a TLIP block is performed under sterile conditions and ultrasound guidance, after the surgical procedure is completed but before the patient is awakened. A total of 20 mL of 0.25% bupivacaine is injected into the thoracolumbar fascial plane, and spread is confirmed via ultrasound.

TLIP Block

In addition to standard perioperative analgesia, a Quadro Iliac Plane Block is performed under sterile conditions and ultrasound guidance, after the surgical procedure is completed but before the patient is awakened. A total of 20 mL of 0.25% bupivacaine is injected into the quadro iliac plane at the level of the iliac crest, and spread is confirmed via ultrasound.

Quadro Iliac Plane Block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 to 80 years
  • American Society of Anesthesiologists (ASA) physical status I to III
  • scheduled for lumbar microdiscectomy surgery

You may not qualify if:

  • Known allergy to local anesthetics
  • Any other significant drug allergies related to the study interventions
  • Pregnancy
  • Pre-existing psychiatric or neurological disorders
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medipol University

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Canikli Adiguzel S, Akyurt D, Bahadir Altun H, Ultan Ozgen G, Akdeniz S, Bayraktar B, Tulgar S, Yigit Y. Posterior Quadratus Lumborum Block or Thoracolumbar Interfascial Plane Block and Postoperative Analgesia after Spinal Surgery: A Randomized Controlled Trial. J Clin Med. 2023 Nov 21;12(23):7217. doi: 10.3390/jcm12237217.

    PMID: 38068268BACKGROUND
  • Hu Z, Han J, Jiao B, Jiang J, Sun Y, Lv Z, Wang J, Tian X, Wang H. Efficacy of Thoracolumbar Interfascial Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: A Meta-analysis of Randomized Clinical Trials. Pain Physician. 2021 Nov;24(7):E1085-E1097.

    PMID: 34704718BACKGROUND
  • Yildirim Uslu E. Effect of Quadratus Lumborum Block in Patients With Acute-Subacute Unilateral Lumbar Strain. Cureus. 2024 May 24;16(5):e61014. doi: 10.7759/cureus.61014. eCollection 2024 May.

    PMID: 38915966BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 24, 2025

First Posted

February 28, 2025

Study Start

March 10, 2025

Primary Completion

March 10, 2026

Study Completion

April 10, 2026

Last Updated

December 8, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

only IPD used in the results publication

Locations