NephrolithiasisNCT07258901
Postoperative Analgesia Practices After Percutaneous Nephrolithotomy
An observational study of Nephrolithiasis, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate the effectiveness and safety of different postoperative analgesia methods used in patients undergoing percutaneous nephrolithotomy (PCNL). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nephrolithiasis
- Type of treatment
- Injection or infusion
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 2 Aug 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults aged 18-65 years
- ASA physical status I-III
- Undergoing unilateral PCNL
- Providing written informed consent
Who cannot join
- 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
Show all 9Show fewer
- Chronic opioid use, alcohol or substance abuse history
- Previous PCNL or open renal surgery on the same side
- Refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Haseki Training and Research Hospital
Istanbul, Sultangazi, 34265
Hilal Caglar, M.D, +905442593143, drhilalsinan@gmail.com
Onur Coban, M.D, +905454829491, onurcoban92@hotmail.com
About this study
Official title: Optimizing Postoperative Pain Management After Percutaneous Nephrolithotomy: A Comparative Clinical Assessment
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.
Read the detailed description
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
- Nephrolithiasis
- Keywords
- Percutaneous Nephrolithotomy, Postoperative Analgesia, Pain Management, Regional Anesthesia, Nephrolithiasis
- Medical subject headings
- Nephrolithiasis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| quadro iliac plane block | quadro iliac plane block | |
| erector spinae nerve block | erector spinae nerve block | |
| Intravenous opioid-based analgesia | Intravenous opioid-based analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative opioid consumption
Cumulative opioid consumption in the first 24 hours
Measured: 24 hours
Secondary outcomes (6)
Pain scores at rest and during movement
Pain intensity measured using the Numeric Rating Scale (NRS), a validated 11-point pain scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores represent worse pain
Measured: 0, 2, 6, 12, and 24 hours postoperatively
Time to first analgesic request
Time to first analgesic request
Measured: Postoperative 24 hours
Need for rescue analgesics
Need for rescue analgesics
Measured: 24 hours
Intraoperative opioid consumption
Intraoperative opioid consumption
Measured: During surgery
Antiemetic medication use
Antiemetic medication use
Measured: 24 hours
Patient satisfaction score
Patient satisfaction regarding postoperative analgesia, assessed using a Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 represents no satisfaction and 10 represents the highest possible satisfaction. Higher scores indicate better satisfaction.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion2 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlke Dolgun, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258901
- Sponsor's protocol ID
- 231-2025
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Postoperative Pain Management After Percutaneous Nephrolithotomy: A Comparative Clinical Assessment
- ClinicalTrials.gov ID
- NCT07258901
- Acronym / sponsor ID
- 231-2025
- Conditions
- Nephrolithiasis
- Keywords
- Percutaneous Nephrolithotomy, Postoperative Analgesia, Pain Management, Regional Anesthesia, Nephrolithiasis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 2 Aug 2026 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| quadro iliac plane block | – | –quadro iliac plane block |
| erector spinae nerve block | – | –erector spinae nerve block |
| Intravenous opioid-based analgesia | – | –Intravenous opioid-based analgesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Adults aged 18-65 years
- ASA physical status I-III
- Undergoing unilateral PCNL
- Providing written informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cumulative opioid consumption
Time frame: 24 hours
Cumulative opioid consumption in the first 24 hours
6 secondary outcomes
Pain scores at rest and during movement
Time frame: 0, 2, 6, 12, and 24 hours postoperatively
Time to first analgesic request
Time frame: Postoperative 24 hours
Need for rescue analgesics
Time frame: 24 hours
Intraoperative opioid consumption
Time frame: During surgery
Antiemetic medication use
Time frame: 24 hours
Patient satisfaction score
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
Related trials for Nephrolithiasis
RecruitingPhase 1/2
Dexamethasone for Ureteral STent Symptoms (DUSTS)
Ureteral Stent-Related Symptom
Not yet recruitingEarly Phase 1
Phosphate & Kidney Stones
Kidney Stones, Calcium Oxalate Kidney Stones
Recruiting
Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology
Urolithiasis, Stones, Kidney
Active, not recruitingObservational study
A Retrospective, Multi-center Real-world Study of Steerable Ureteroscopic Renal Evacuation (SURE) Procedure With the CVAC® System
Urolithiasis, Kidney Stone
Recruiting
Supervised Endoscopic Tele-controlled Intelligent Lithotripsy
Renal Stone
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephrolithiasis, run by Istinye University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative opioid consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.