Postoperative Analgesia Practices After Percutaneous Nephrolithotomy

NCT ID: NCT07258901

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-08-02

Brief Summary

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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.

Detailed Description

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This is a prospective observational clinical study designed to examine the impact of various postoperative analgesia strategies on pain outcomes in patients undergoing percutaneous nephrolithotomy (PCNL). In routine practice at the participating center, regional block techniques and intravenous analgesia protocols are commonly used, and different anesthesiologists may choose different postoperative analgesia approaches.

All patients will undergo standard general anesthesia according to institutional protocols. Intraoperative monitoring will include heart rate, mean arterial pressure, oxygen saturation, duration of surgery, opioid consumption, and intraoperative complications. Postoperative follow-up will include assessment of pain scores (NRS) at 0, 2, 6, 12, and 24 hours, cumulative opioid consumption, need for rescue analgesics, time to first analgesic request, incidence of postoperative nausea and vomiting (PONV), antiemetic use, patient satisfaction, and any analgesia-related adverse events.

Demographic characteristics (age, sex, BMI, ASA status), stone features (location, side, volume), and intraoperative variables will be recorded. Data will be collected prospectively and stored securely.

The primary goal is to compare the effect of different postoperative analgesia methods on cumulative opioid use in the first 24 hours. Secondary aims include evaluating pain scores, rescue analgesic need, intraoperative opioid use, time to first analgesic request, PONV incidence, patient satisfaction, and adverse effects.

Conditions

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Nephrolithiasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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quadro iliac plane block

quadro iliac plane block

No interventions assigned to this group

erector spinae nerve block

erector spinae nerve block

No interventions assigned to this group

Intravenous opioid-based analgesia

Intravenous opioid-based analgesia

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istinye University

OTHER

Sponsor Role lead

Responsible Party

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İlke Dolgun

assoc prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Haseki Training and Research Hospital

Istanbul, Sultangazi, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Facility Contacts

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Hilal Caglar, M.D

Role: primary

+905442593143

Onur Coban, M.D

Role: backup

+905454829491

Other Identifiers

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231-2025

Identifier Type: -

Identifier Source: org_study_id

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