NCT07258901

Brief Summary

This prospective observational study aims to evaluate the effectiveness and safety of different postoperative analgesia methods used in patients undergoing percutaneous nephrolithotomy (PCNL). Analgesia techniques are determined independently by the responsible anesthesiologist as part of routine clinical practice, and the study team does not intervene in treatment decisions.

Trial Health

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Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Progress65%
Dec 2025Aug 2026

First Submitted

Initial submission to the registry

November 20, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2026

Last Updated

December 2, 2025

Status Verified

December 1, 2025

Enrollment Period

8 months

First QC Date

November 20, 2025

Last Update Submit

December 1, 2025

Conditions

Keywords

Percutaneous NephrolithotomyPostoperative AnalgesiaPain ManagementRegional AnesthesiaNephrolithiasis

Outcome Measures

Primary Outcomes (1)

  • Cumulative opioid consumption

    Cumulative opioid consumption in the first 24 hours

    24 hours

Secondary Outcomes (6)

  • Pain scores at rest and during movement

    0, 2, 6, 12, and 24 hours postoperatively

  • Time to first analgesic request

    Postoperative 24 hours

  • Need for rescue analgesics

    24 hours

  • Intraoperative opioid consumption

    During surgery

  • Antiemetic medication use

    24 hours

  • +1 more secondary outcomes

Study Arms (3)

quadro iliac plane block

quadro iliac plane block

erector spinae nerve block

erector spinae nerve block

Intravenous opioid-based analgesia

Intravenous opioid-based analgesia

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 to 65 years undergoing unilateral percutaneous nephrolithotomy (PCNL) at Haseki Training and Research Hospital. All participants are ASA physical status I-III and receive postoperative analgesia according to routine clinical practice.

You may qualify if:

  • Adults aged 18-65 years
  • ASA physical status I-III
  • Undergoing unilateral PCNL
  • Providing written informed consent

You may not qualify if:

  • Known allergy to local anesthetics
  • Coagulopathy or contraindication to regional anesthesia
  • BMI \> 35 kg/m²
  • Cognitive or communication impairment affecting pain evaluation
  • Neurological or psychiatric disorders
  • Musculoskeletal abnormalities
  • Chronic opioid use, alcohol or substance abuse history
  • Previous PCNL or open renal surgery on the same side
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Sultangazi, 34265, Turkey (Türkiye)

Location

MeSH Terms

Conditions

NephrolithiasisAgnosia

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assoc prof

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 2, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 2, 2026

Last Updated

December 2, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared.

Locations