NCT07370415

Brief Summary

Lumbar instrumentation surgery is associated with severe postoperative pain due to extensive tissue dissection and prolonged muscle retraction during the procedure. Inadequate postoperative pain control may result in delayed mobilization, increased cardiopulmonary complications, and prolonged hospital stay. Ultrasound-guided regional analgesia techniques are increasingly used to improve postoperative pain management after lumbar spine surgery. The thoracolumbar interfascial plane (TLIP) block has been shown to provide effective analgesia for lumbar instrumentation surgery, and its modified technique (mTLIP) has been reported to enhance postoperative pain control. The quadro-iliac plane (QIP) block is a newly described fascial plane block with promising results in lumbar spine surgery. This randomized controlled trial aims to compare the postoperative analgesic effectiveness of the modified thoracolumbar interfascial plane block and the quadro-iliac plane block in patients undergoing lumbar instrumentation surgery.

Trial Health

63
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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
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress45%
Mar 2026Sep 2026

First Submitted

Initial submission to the registry

January 12, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 20, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

January 12, 2026

Last Update Submit

March 5, 2026

Conditions

Keywords

Lumbar instrumentation surgeryPostoperative PainModified thoracolumbar interfascial plane blockQuadro-iliac plane block

Outcome Measures

Primary Outcomes (1)

  • Postoperative 48-Hour PCA Opioid Consumption

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

    Postoperative 0-8, 8-16, 16-24, 24-48 intervals

Secondary Outcomes (6)

  • 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

    Postoperative 48 hours

  • Time of first request for rescue analgesia

    Postoperative 48 hours

  • Length of Hospital Stay

    Patients will remain under observation for at least 2 weeks until their postoperative discharge. Follow-up will be completed upon discharge. The length of hospital stay will be recorded.

  • +1 more secondary outcomes

Study Arms (2)

Modified Thoracolumbar Interfascial Plane Block (mTLIP) Group

EXPERIMENTAL

Participants in this group will receive a bilateral ultrasound-guided modified thoracolumbar interfascial plane block (mTLIP) performed at the end of lumbar instrumentation surgery while in the prone position. Under sterile conditions, the ultrasound probe will be placed in the parasagittal plane at the midpoint of the surgical incision, taking into account the operated lumbar levels. 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. After confirmation of correct needle placement with saline, 20 mL of 0.25% bupivacaine will be injected on each side. The block will be performed bilaterally, with a total volume of 40 mL of 0.25% bupivacaine.

Procedure: Modified Thoracolumbar Interfascial Plane Block (mTLIP)

Quadro-Iliac Plane Block (QIPB) Group

EXPERIMENTAL

Participants in this group will receive a bilateral ultrasound-guided quadro-iliac plane block (QIPB) performed at the end of lumbar instrumentation surgery while in the prone position. Under sterile conditions, a convex ultrasound probe will be placed at the point where the quadratus lumborum muscle attaches to the iliac crest. The erector spinae and quadratus lumborum muscles will be identified, and correct needle placement will be confirmed with saline injection. Subsequently, 20 mL of 0.25% bupivacaine will be injected on each side, with visualization of local anesthetic spread between the erector spinae and quadratus lumborum muscles. The block will be performed bilaterally, with a total volume of 40 mL of 0.25% bupivacaine.

Procedure: Quadro-Iliac Plane Block (QIPB):

Interventions

An ultrasound-guided bilateral fascial plane block in which local anesthetic is injected at the point where the quadratus lumborum muscle attaches to the iliac crest, allowing spread between the erector spinae and quadratus lumborum muscles. The block is performed under sterile conditions at the end of surgery using 0.25% bupivacaine (20 mL per side; total volume 40 mL).

Quadro-Iliac Plane Block (QIPB) Group

An ultrasound-guided bilateral fascial plane block in which local anesthetic is injected into the interfascial plane between the longissimus and iliocostalis muscles at the operated lumbar levels. The block is performed under sterile conditions at the end of surgery using 0.25% bupivacaine (20 mL per side; total volume 40 mL).

Modified Thoracolumbar Interfascial Plane Block (mTLIP) Group

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 instrumentation 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

Nilufer, Bursa, 16110, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

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
INVESTIGATOR, 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

January 12, 2026

First Posted

January 27, 2026

Study Start

March 20, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations