NCT07789509

Brief Summary

This randomized clinical trial aims to evaluate and compare the analgesic efficacy and functional outcomes of the quadro-iliac plane block (QIPB) and the erector spinae plane block (ESPB) in patients undergoing lumbar stabilization surgery. The primary outcome is the Numeric Rating Scale (NRS) within the first 48 hours after surgery. Secondary outcomes include postoperative total opioid consumption, incidence of quadriceps motor block, time to first ambulation, block performance time, falls, length of hospital stay, block-related complications (hematoma, local anesthetic systemic complications, vascular puncture, and infection), patient satisfaction assessed using a Likert scale, and incidence of postoperative nausea and vomiting.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Nov 2026

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

July 1, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

November 15, 2026

Expected
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2027

Last Updated

August 27, 2026

Status Verified

July 1, 2026

Enrollment Period

9 months

First QC Date

July 1, 2026

Last Update Submit

August 24, 2026

Conditions

Keywords

QIPBESPLumbarAnalgesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain scores

    Postoperative pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores at rest will be recorded in the post-anesthesia care unit and at postoperative 6, 24, 36, and 48 hours. Pain scores during movement will be assessed during passive flexion of the operated hip at postoperative 6, 24, 36, and 48 hours.

    6,24,36,48 hours

Secondary Outcomes (9)

  • Postoperative opioid consumption

    postoperative 24 and 48 hours

  • Incidence of quadriceps motor block

    Postoperative 3, 6, and 24 hours

  • Time to first ambulation

    Postoperative day 1

  • Patient satisfaction

    Postoperative 48 hours

  • Postoperative nausea and vomiting (PONV)

    Postoperative 48 hours

  • +4 more secondary outcomes

Study Arms (2)

quadro-iliac plane block (QIPB)

ACTIVE COMPARATOR

Participants allocated to the QIPB group will receive an ultrasound-guided quadro-iliac plane block after the induction of general anesthesia. Following standard aseptic preparation, 30 mL of 0.25% bupivacaine will be administered into the target fascial plane under ultrasound guidance after confirming the absence of blood on aspiration.

Procedure: Quadro iliac Plane Block

Erector Spina Plane Block

ACTIVE COMPARATOR

Participants in the ESPB group will undergo an ultrasound-guided erector spinae plane block after the induction of general anesthesia. A total of 20 mL of 0.25% bupivacaine will be administered into the target fascial plane under ultrasound guidance after confirming the absence of blood on aspiration.

Procedure: Quadro iliac Plane Block

Interventions

Participants allocated to the QIPB group will receive an ultrasound-guided quadro-iliac plane block after the induction of general anesthesia. Following standard aseptic preparation, 30 mL of 0.25% bupivacaine will be administered into the target fascial plane under ultrasound guidance after confirming the absence of blood on aspiration.

Erector Spina Plane Blockquadro-iliac plane block (QIPB)

Eligibility Criteria

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

You may qualify if:

  • Age between 18 and 80 years
  • American Society of Anesthesiologists physical status I-III
  • Scheduled for elective primary lumbar stabilization surgery
  • Surgery planned under general anesthesia
  • Ability to understand and use the Numeric Rating Scale
  • Written informed consent provided

You may not qualify if:

  • Refusal to participate
  • Revision lumbar stabilization surgery
  • Contraindication to regional anesthesia
  • Contraindication to peripheral nerve/plane block
  • Known allergy to local anesthetics or study drugs
  • Coagulopathy or anticoagulant use incompatible with neuraxial/regional -anesthesia
  • Infection at the block injection site
  • Pre-existing neurological deficit involving the lower extremities (unrelated to t-he current spinal pathology)
  • Peripheral neuropathy
  • Chronic opioid use
  • Cognitive impairment or inability to communicate reliably
  • Severe hepatic or renal failure
  • Body mass index \> 35 kg/m2
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Damla Kaytancı Özçelik, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2026

First Posted

August 27, 2026

Study Start (Estimated)

November 15, 2026

Primary Completion (Estimated)

August 15, 2027

Study Completion (Estimated)

September 15, 2027

Last Updated

August 27, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share