NCT07480278

Brief Summary

The aim of this prospective randomized clinical study is to compare the analgesic efficacy and side effects of modified thoracolumbar interfascial plane block and quadroiliac plane block applied preoperatively in patients undergoing lumbar microdiscectomy surgery.The study will include a total of 80 patients aged 18-65 years with ASA I-III, with 40 patients in each group( Group mTLIP and Group QIPB) undergoing lumbar microdiscectomy surgery. The primary objective of the study is to compare groups in terms of PCA opioid consumption during the 48-hour postoperative period. Secondary objectives are to compare groups in terms of QoR-15 recovery score, dynamic and static numerical rating scale scores, total rescue analgesic use, time to first request for rescue analgesia, length of hospital stay, block and opioid-related side effects and complications, and perioperative remifentanil infusion dose.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Mar 2026

Shorter than P25 for not_applicable

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

Study Progress37%
Mar 2026Sep 2026

First Submitted

Initial submission to the registry

March 9, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

March 25, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

March 9, 2026

Last Update Submit

March 26, 2026

Conditions

Keywords

Postoperative painQuadro-iliac plane blockLumbar MicrodiscectomyModified thoracolumbar interfascial plane block

Outcome Measures

Primary Outcomes (1)

  • 1. Postoperative 48-Hour PCA Opioid Consumption

    Description: Total amount of opioid delivered by the patient-controlled analgesia (PCA) device during the first 48 hours after surgery, recorded in milligrams (mg).

    Time Frame: Postoperative 0-8, 8-16, 16-24 24-48 hours intervals

Secondary Outcomes (7)

  • QoR-15 Recovery Score

    Postoperative 24th and 48th hours

  • Dynamic and static Numeric Rating Scale scores

    0, 2, 4, 8, 16, 24, and 48 hours postoperatively

  • Total rescue analgesic dose

    Time Frame: Postoperative 48 hours

  • Time of first request for rescue analgesia

    Time Frame: Postoperative 48 hours

  • Length of Hospital Stay

    the day of discharge from the hospital (assessed up to 10 days)

  • +2 more secondary outcomes

Study Arms (2)

Group mTLIP

EXPERIMENTAL

Patients in this group will undergo bilateral mTLIP block under ultrasound guidance prior to surgery.

Procedure: Modified Thoracolumbar Interfascial Plane Block (mTLIP)

Group QIPB

EXPERIMENTAL

Patients in this group will undergo bilateral QIPB block under ultrasound guidance prior to surgery.

Procedure: Quadro-Iliac Plane Block (QIPB)

Interventions

This is a fascial plane block in which a local anesthetic is injected into the interfascial plane between the longissimus and iliocostalis muscles. Participants in this group will undergo bilateral modified thoracolumbar interfascial plane blocks (mTLIP) under ultrasound guidance prior to surgery. Under sterile conditions, with the patient in the prone position, the ultrasound probe will be placed in the parasagittal plane at the midpoint of the surgical incision, taking into account the lumbar levels to be operated on. The paraspinal muscles will be identified, and using an in-plane technique, the needle will be advanced into the interfascial plane between the longissimus and iliocostalis muscles. Correct needle placement will be confirmed with saline solution. A total of 40 mL of 0.25% bupivacaine and 5 µg/mL (1:200,000) adrenaline-containing local anesthetic solution (20 mL for each side) will be used for the block procedures.

Group mTLIP

This is a fascial plane block is a procedure in which local anesthetic is injected at the point where the quadratus lumborum muscle attaches to the iliac crest, allowing it to spread between the erector spinae and quadratus lumborum muscles. Participants in the QIPB Group will undergo bilateral quadrioliac plane blocks (QIPB) under ultrasound guidance prior to surgery. Under sterile conditions, with the patient in the prone position, a convex ultrasound probe will be placed at the point where the quadratus lumborum muscle attaches to the iliac crest to identify the erector spinae and quadratus lumborum muscles. After confirming the needle placement with saline, a local anesthetic solution containing 0.25% bupivacaine and 5 µg/mL (1:200,000) adrenaline will be administered, total 40 mL (20 mL for each side). The spread of the local anesthetic solution between the erector spinae and quadratus lumborum muscles will be visualized

Group QIPB

Eligibility Criteria

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

You may qualify if:

  • Age between 18 and 65 years
  • Classified as American Society of Anesthesiologists physical status I-III
  • Scheduled for elective lumbar microdiscectomy surgery under general anesthesia
  • Provision of written informed consent

You may not qualify if:

  • Use of anticoagulant medications or presence of bleeding diathesis
  • Known allergy or hypersensitivity to local anesthetics or opioid drugs
  • Infection at the planned block site
  • Alcohol or drug dependence
  • Cognitive impairment preventing reliable pain assessment
  • Pregnancy or lactation
  • History of previous lumbar spine surgery
  • Diabetes mellitus
  • Renal or hepatic insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa City Hospital

Bursa, Nilüfer, 16110, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • Turan EI, Aslan C, Berber K, Sarban O, Sahin AS. Efficacy of quadro-iliac plane block in single level lumbar discectomies: a case series for novel block. Minerva Anestesiol. 2024 Dec;90(12):1159-1160. doi: 10.23736/S0375-9393.24.18314-9. Epub 2024 Sep 11. No abstract available.

    PMID: 39258831BACKGROUND
  • Ciftci B, Ekinci M. A prospective and randomized trial comparing modified and classical techniques of ultrasound-guided thoracolumbar interfascial plane block. Agri. 2020 Nov;32(4):186-192. doi: 10.14744/agri.2020.72325.

    PMID: 33398870BACKGROUND
  • Turan EI, Sahin AS. Quadro-iliac plane block (QIPB) in lumbar stabilisation surgeries: A case series. Indian J Anaesth. 2025 Feb;69(2):244-245. doi: 10.4103/ija.ija_1077_24. Epub 2025 Jan 29. No abstract available.

    PMID: 40160919BACKGROUND
  • Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Girit M, Akin T, Narayanan M, Alici HA. Ultrasound guided quadro-iliac plane block: another novel fascial plane block. Pain Med. 2024 May 3;25(6):370-373. doi: 10.1093/pm/pnae018.

    PMID: 38459608BACKGROUND
  • Alver S, Ciftci B, Celik EC, Sargolzaeimoghaddam M, Cetinkal A, Erdogan C, Ahiskalioglu A. Postoperative recovery scores and pain management: a comparison of modified thoracolumbar interfascial plane block and quadratus lumborum block for lumbar disc herniation. Eur Spine J. 2024 Jan;33(1):118-125. doi: 10.1007/s00586-023-07812-3. Epub 2023 Jun 14.

    PMID: 37314577BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Merih Yildiz Eglen, MD

CONTACT

Mursel Ekinci, Assoc prof MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 18, 2026

Study Start

March 25, 2026

Primary Completion (Estimated)

July 25, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations