NCT07711522

Brief Summary

Posterior spinal instrumentation can cause significant postoperative pain due to extensive muscle dissection, manipulation of bone tissue, and implant placement. Providing optimal analgesia in the postoperative period is important for patients' functional recovery and early mobilization. Inadequate control of postoperative pain may delay recovery, increase the risk of opioid dependence, and lead to respiratory complications. Although opioid analgesics are effective in reducing pain during the postoperative period, they are associated with side effects such as nausea, vomiting, respiratory depression, and the risk of dependence. Therefore, the use of non-opioid analgesic approaches is important for patient safety and comfort. For these reasons, regional analgesia techniques such as the modified thoracolumbar interfascial plane (TLIP) block and the erector spinae plane (ESP) block have recently become increasingly popular for postoperative pain control. The quadro-iliac plane block is a novel technique that targets the attachment area of the posterior surface of the quadratus lumborum muscle on the inner surface of the iliac crest. In this block, the spread of local anesthetic along the fascial planes surrounding the quadratus lumborum muscle may provide an anatomical mechanism contributing to analgesia of the lumbosacral, paraspinal, lower abdominal, and gluteal regions. However, as the quadro-iliac plane block is a new technique, there are not yet sufficient studies on this topic in the literature. The primary objective of our study is to evaluate the effect of ultrasound-guided quadro-iliac plane block (QIPB) on postoperative opioid consumption after posterior spinal instrumentation. The secondary objectives are to compare opioid-related side effects, such as nausea, vomiting, and respiratory depression, as well as postoperative NRS (Numeric Rating Scale) pain scores between the groups.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
11mo left

Started Aug 2026

Shorter than P25 for early_phase_1

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 Progress2%
Aug 2026Jul 2027

First Submitted

Initial submission to the registry

July 14, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

11 months

First QC Date

July 14, 2026

Last Update Submit

July 14, 2026

Conditions

Keywords

Posterior spinal instrumentationPostoperative analgesiaquadro-iliac plane block

Outcome Measures

Primary Outcomes (1)

  • The effect of ultrasound-guided quadro-iliac plane block (QIPB) on postoperative opioid consumption f

    The primary objective of this study is to evaluate the effect of ultrasound-guided quadro-iliac plane block (QIPB) on postoperative opioid consumption following posterior spinal instrumentation surgery.

    Postoperative 24 hours

Secondary Outcomes (2)

  • NRS of patients

    Postoperative 24 hours

  • Opioid related adverse effects

    Postoperative 24 hours

Study Arms (2)

Quadro-iliac block group

ACTIVE COMPARATOR
Drug: Fentanyl (IV)Drug: MeperidineDrug: Paracetamol (acetaminophen)

Wound infiltration Group

OTHER
Drug: Fentanyl (IV)Drug: MeperidineDrug: Paracetamol (acetaminophen)

Interventions

If the patient's NRS is 4 or more even though 1 gr IV paracetamol and IV PCA, meperidine 0.5 mg/kg w'll be administered as rescue analgesic

Quadro-iliac block groupWound infiltration Group

All patients will have an IV PCA with fentanyl.The PCA settings will consist of a 10-µg fentanyl bolus dose with a 10-minute lockout interval.

Quadro-iliac block groupWound infiltration Group

An order for intravenous paracetamol 1 g every 8 hours will be placed for all patients.

Quadro-iliac block groupWound infiltration Group

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medipol Mega Hastaneler Kompleksi

Istanbul, Bagcilar, 34214, Turkey (Türkiye)

Location

Related Publications (3)

  • 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, Cetinkal A, Alver S, Ahiskalioglu A. Quadro-iliac plane block for lumbar multi-level instrumentation surgery: far away from the surgical area. Minerva Anestesiol. 2025 Apr;91(4):358-359. doi: 10.23736/S0375-9393.24.18680-4. Epub 2024 Dec 10. No abstract available.

  • Zamudio D, Fernandez L, Rodriguez A, Delgado D. Postoperative erector spinae plane block does not reduce morphine consumption after lumbar spinal fusion: A randomized controlled trial. J Clin Anesth. 2025 Nov;107:112022. doi: 10.1016/j.jclinane.2025.112022. Epub 2025 Sep 26.

MeSH Terms

Interventions

FentanylMeperidineAcetaminophen

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsonipecotic AcidsAcids, HeterocyclicAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

July 14, 2026

First Posted

July 17, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

July 17, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because there is no plan for public data sharing for this study.

Locations