NCT07203859

Brief Summary

Our aim was to investigate the effect of quadro iliac plane block on postoperative analgesia in patients undergoing percutaneous nephrolithotomy surgery and to determine which areas of the skin this block anesthetizes.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
6mo left

Started Sep 2025

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
active not 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 Progress56%
Sep 2025Oct 2026

First Submitted

Initial submission to the registry

September 25, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

September 25, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 2, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

11 months

First QC Date

September 25, 2025

Last Update Submit

November 20, 2025

Conditions

Keywords

postoperative painregional anesthesiapercutaneous nephrolithotomyquadroiliac plane blockopioid free analgesiaibuprofennovel fascial plane block

Outcome Measures

Primary Outcomes (1)

  • Numeric Rating Scale (NRS) Scores

    Description: Numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.

    Postoperative 24 hours

Secondary Outcomes (2)

  • Dermatome Area

    Postoperative 2 hours

  • Total tramadol consumption

    Postoperative 24 hours

Study Arms (2)

Control group

NO INTERVENTION

No non-routine procedures will be performed on this group.

Quadro-İliac Plane Block(QİPB)

ACTIVE COMPARATOR

For this group, after the surgical procedure is completed, the patient will be placed in a lateral position with the operated side facing up, and a QIPB will be performed. With the patient in the lateral position, the spinous process of the L3 vertebra will first be imaged with an ultrasound probe positioned transversely in the midline. Then, by slightly shifting the probe laterally, the transverse process of the vertebra will be visualized within the erector spinae muscle. The probe will then be rotated in the sagittal plane and advanced caudally about 1 cm, visualizing the crista iliaca. On the cranial side of the crista iliaca, the erector spinae muscle, quadratus lumborum, and psoas major muscles will be visualized sequentially. With the needle direction cranial to caudal, the crista iliaca will be gently touched, and the needle will be positioned between the erector spinae and the quadratus lumborum muscle. After injecting 40 ml of 0.25% bupivacaine, the needle will be injected.

Procedure: Quadro-İliac Plane Block(QİPB)

Interventions

40 mL of 0.25% bupivacaine

Quadro-İliac Plane Block(QİPB)

Eligibility Criteria

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

You may qualify if:

  • Adult patients over 18 years of age who underwent percutaneous nephrolithotomy under general anesthesia and were I-II-III according to the American Society of Anesthesiologists (ASA) risk classification were included in the study.

You may not qualify if:

  • patients who did not give consent,
  • patients with coagulopathy,
  • patients with signs of infection at the block application site,
  • patients using anticoagulants,
  • patients with known allergies to any of the study drugs,
  • patients with unstable hemodynamics,
  • patients who could not cooperate during postoperative pain assessment
  • patients who wanted to withdraw from the study,
  • patients with alcohol and drug addiction,
  • patients with musculoskeletal abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sivas Cumhuriyet University

Sivas, Sivas, 58140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • OĞUZ GÜNDOĞDU

    Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR
  • SAMET YENİHAN

    Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 25, 2025

First Posted

October 2, 2025

Study Start

September 25, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

November 21, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations