NCT07370428

Brief Summary

Lumbar instrumentation surgery is associated with significant postoperative pain. This study evaluates the analgesic effectiveness of the ultrasound-guided Quadro-Iliac Plane Block in patients undergoing lumbar instrumentation surgery, aiming to assess the efficacy of this newly developed technique for postoperative pain management.

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 postoperative-pain

Timeline
0mo left

Started Jan 2026

Shorter than P25 for not_applicable postoperative-pain

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 Progress90%
Jan 2026Jul 2026

First Submitted

Initial submission to the registry

December 26, 2025

Completed
25 days until next milestone

Study Start

First participant enrolled

January 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

December 26, 2025

Last Update Submit

March 5, 2026

Conditions

Keywords

Quadro-Iliac Plane BlockLumbar Instrumentation SurgeryPain Management

Outcome Measures

Primary Outcomes (2)

  • 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

  • QoR-15 Recovery Score

    The investigators will use the Turkish version of Quality of Recovery (QoR) / QoR-15 questionairre PART A How have you been feeling in the last 24 hours? (0 to 10, where: 0 = none of the time \[poor\] and 10 = all of the time \[excellent\]) Able to breathe easily Been able to enjoy food Feeling rested Have had a good sleep Able to look after personal toilet and hygiene unaided Able to communicate with Getting support from hospital doctors and nurses Able to return to work or usual home activities Feeling comfortable and in control Having a feeling of general well-being PART B Have you had any of the following in the last 24 hours? (10 to 0, where: 10 = none of the time \[excellent\] and 0 = all of the time \[poor\]) Moderate pain Severe pain Nausea or vomiting Feeling worried or anxious Feeling sad or depressed

    Postoperative 24th and 48th hours

Secondary Outcomes (5)

  • Dynamic and static NRS scores

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

  • Total rescue analgesic dose

    Postoperative 24th and 48th 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 (day).

  • Block and Opioid-Related Adverse Effects and Complications

    Postoperative 48-Hours

Study Arms (2)

Group QIPB

ACTIVE COMPARATOR

Participants in this arm will receive an ultrasound-guided Quadro-Iliac Plane Block. The block will be performed at the end of surgery, before extubation, with the patient in the prone position under standard sterilization conditions. A convex ultrasound probe will be placed at the level where the quadratus lumborum muscle (QLM) attaches to the iliac crest to visualize the erector spinae muscle (ESM) and the underlying QLM. The block location will be confirmed by injecting 2 mL of isotonic solution at the QLM-iliac crest junction. Subsequently, 20 mL of 0.25% bupivacaine will be injected, and the spread of the local anesthetic between the ESM and QLM will be observed under ultrasound guidance. The block will be performed bilaterally with a total volume of 40 mL.

Procedure: Quadro-Iliac Plane Block

Group Control

NO INTERVENTION

Interventions

Ultrasound-guided regional anesthesia technique performed between the erector spinae muscle and the quadratus lumborum muscle at the iliac crest level.

Group QIPB

Eligibility Criteria

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

You may qualify if:

  • Classified as American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for elective lumbar instrumentation surgery
  • Surgery performed under general anesthesia
  • Provision of written informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa City Hospital

Bursa, 16110, Turkey (Türkiye)

RECRUITING

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.

    PMID: 38459608BACKGROUND
  • 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
  • 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.

    PMID: 39656149BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Central Study Contacts

Mursel Ekinci, Assoc prof,MD

CONTACT

Merih Yıldız Eglen, 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

December 26, 2025

First Posted

January 27, 2026

Study Start

January 20, 2026

Primary Completion

March 31, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations