NCT07354581

Brief Summary

Lumbar instrumentation surgery is associated with significant postoperative pain. This study compares the postoperative analgesic effectiveness of ultrasound-guided Erector Spinae Plane Block and Quadro-Iliac Plane Block in patients undergoing lumbar instrumentation surgery.

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
2mo left

Started Jan 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 Progress54%
Jan 2026Jul 2026

First Submitted

Initial submission to the registry

December 31, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

January 20, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 21, 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 31, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

December 31, 2025

Last Update Submit

March 26, 2026

Conditions

Pain, Postoperative

Keywords

Lumbar instrumentationPostoperative pain managementErector Spinae 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 24th and 48th hours

  • Time of first request for rescue analgesia

    Postoperative 48 hours

  • Length of Hospital Stay

    The time from the end of the surgery to discharge from the hospital(day)

  • +1 more secondary outcomes

Study Arms (2)

Erector Spinae Plane Block (ESPB)

ACTIVE COMPARATOR

Participants in this arm will receive an ultrasound-guided Erector Spinae Plane Block at the end of surgery, before extubation, with the patient in the prone position under standard sterilization conditions. The block will be performed bilaterally as part of a standardized multimodal postoperative analgesia protocol following lumbar instrumentation surgery.

Procedure: Erector Spinae Plane Block

Quadro-Iliac Plane Block (QIPB)

ACTIVE COMPARATOR

Participants in this arm will receive an ultrasound-guided Quadro-Iliac Plane Block at the end of surgery, before extubation, with the patient in the prone position under standard sterilization conditions. The block will be performed bilaterally as part of a standardized multimodal postoperative analgesia protocol following lumbar instrumentation surgery.

Procedure: Quadro-Iliac Plane Block

Interventions

Erector Spinae Plane BlockPROCEDURE

An ultrasound-guided Erector Spinae Plane Block will be performed at the end of surgery, before extubation, with the patient in the prone position under standard sterilization conditions. The ultrasound probe will be placed in the parasagittal plane at the level corresponding to the surgical site to visualize the transverse process and erector spinae muscle. Following confirmation of correct needle placement with 2 mL of normal saline, 20 mL of 0.25% bupivacaine will be injected into the fascial plane deep to the erector spinae muscle. The block will be performed bilaterally, with a total volume of 40 mL, as part of a standardized multimodal postoperative analgesia protocol.

Erector Spinae Plane Block (ESPB)
Quadro-Iliac Plane BlockPROCEDURE

An ultrasound-guided Quadro-Iliac Plane 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 attaches to the iliac crest to visualize the erector spinae muscle and the underlying quadratus lumborum muscle. The block location will be confirmed with the injection of 2 mL of isotonic solution, followed by the injection of 20 mL of 0.25% bupivacaine. The spread of the local anesthetic between the erector spinae muscle and quadratus lumborum muscle will be observed under ultrasound guidance. The block will be performed bilaterally, with a total volume of 40 mL, as part of a standardized multimodal postoperative analgesia protocol.

Quadro-Iliac Plane Block (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 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

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: 38459608RESULT

  • 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: 40160919RESULT

  • 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: 39656149RESULT

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

+905059340629meriheg@yahoo.com

Mursel Ekinci, Assoc prof MD

CONTACT

+905067137596drmurselekinci@gmail.com

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 31, 2025

First Posted

January 21, 2026

Study Start

January 20, 2026

Primary Completion

March 31, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)