NCT07326774

Brief Summary

This prospective observational study aims to evaluate the effect of ultrasound-guided Quadro-Iliac Plane Block (QIPB) on postoperative analgesia in patients undergoing lumbar spinal surgery. Lumbar spinal procedures are commonly associated with significant postoperative pain, which may impair early mobilization and increase opioid consumption. In routine clinical practice, QIPB is increasingly used as part of multimodal analgesia to improve pain control and reduce opioid-related adverse effects. Adult patients scheduled for elective lumbar spinal surgery under general anesthesia will be followed according to routine clinical care. Postoperative analgesia will be managed with intravenous patient-controlled analgesia (PCA) using tramadol, with or without the addition of ultrasound-guided QIPB, based on the preference of the attending anesthesiologist. No intervention or treatment assignment will be performed by the investigators. Postoperative pain scores at rest and during movement, opioid consumption, need for rescue analgesics, incidence of nausea and vomiting, and patient satisfaction will be recorded during the first 24 hours after surgery. The findings of this study are expected to provide further clinical evidence regarding the effectiveness of QIPB as part of multimodal analgesia in lumbar spinal surgery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Jan 2026

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Progress46%
Jan 2026Oct 2026

First Submitted

Initial submission to the registry

December 26, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

January 5, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

December 26, 2025

Last Update Submit

February 19, 2026

Conditions

Keywords

Quadro-Iliac Plane BlockQIPBUltrasound-Guided Regional AnesthesiaLumbar Spinal SurgeryPostoperative AnalgesiaPatient-Controlled Analgesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Intensity

    Postoperative pain intensity assessed using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain.

    Within the first 24 hours after surgery

Secondary Outcomes (4)

  • Total Opioid Consumption

    Within the first 24 hours after surgery

  • Requirement for Rescue Analgesia

    Within the first 24 hours after surgery

  • Postoperative Nausea and Vomiting

    Within the first 24 hours after surgery

  • Patient Satisfaction With Pain Management

    24 hours after surgery

Study Arms (2)

PCA + QIPB Group

Patients who receive standard postoperative intravenous patient-controlled analgesia (PCA) with tramadol in combination with ultrasound-guided Quadro-Iliac Plane Block (QIPB) as part of routine clinical care following lumbar spinal surgery.

Other: QIPB

PCA + LAI Group

Patients who receive standard postoperative intravenous patient-controlled analgesia (PCA) with tramadol alone without the addition of any regional analgesic block following lumbar spinal surgery. In addition, the surgeon will perform local anesthetic infiltration (LAI) of the incision site as part of the routine analgesia protocol.

Other: LAI

Interventions

QIPBOTHER

Quadro-Iliac Plane Block using local anesthetic.

PCA + QIPB Group
LAIOTHER

The surgeon will perform local anesthetic infiltration (LAI) of the incision site.

PCA + LAI Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients aged 18-65 years with ASA physical status I-III and body mass index \<35 kg/m² scheduled for elective posterior lumbar segmental instrumentation surgery under general anesthesia. All participants provide written informed consent prior to enrollment.

You may qualify if:

  • Patients aged between 18 and 65 years
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Body mass index (BMI) \<35 kg/m²
  • Scheduled for elective posterior lumbar spinal instrumentation surgery under general anesthesia

You may not qualify if:

  • Refusal to participate in the study
  • Emergency surgery
  • Local infection or hematoma at the block application site
  • Previous surgery at the block application site
  • Presence of coagulopathy
  • Known allergy or toxicity to local anesthetics
  • History of hematological, renal, or hepatic disease, or advanced respiratory or cardiac failure
  • Chronic analgesic use, chronic alcohol consumption, or substance abuse
  • Inability to speak Turkish or presence of language/communication barriers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Istanbul, 34752, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Oznur Demiroluk, Assoc. Prof.

    Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Türkiye

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elif Acar Deger, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 26, 2025

First Posted

January 8, 2026

Study Start

January 5, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared, as data sharing was not planned at the time of study design and is not included in the ethical approval.

Locations