Percutaneous NephrolithotomyNCT05467878
The Effect of Anesthesia on Pain in Percutaneous Nephrolithotomy
An observational study of Percutaneous Nephrolithotomy, run by Tugba Onur at 1 site in Turkey (Türkiye).
Trial summary
It is aimed to determine the ideal application by determining the effect of different anesthesia methods applied in percutaneous nephrolithotomy surgeries on analgesic consumption and pain level. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Percutaneous Nephrolithotomy
- What is being tested?
- The anesthesia and analgesia technique preferred by the anesthetist will be recorded.
- Type of treatment
- Injection or infusion
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 15 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 600 patients
Who may be able to join
- patient giving consent
- accessing patient information
Who cannot join
- missing information in the patient file
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Anesthesia on Perioperative Pain Level and Analgesic Effect in Patients With Percutaneous Nephrolithotomy
It is aimed to determine the ideal application by determining the effect of different anesthesia methods applied in percutaneous nephrolithotomy surgeries on analgesic consumption and pain level.
Read the detailed description
Different anesthesia methods are used in percutaneous nephrolithotomy.In addition to traditional analgesia methods such as intravenous paracetamol, NSAIDs, opioids, various methods such as epidiural analgesia or blocks added to general anesthesia are used.In this study, it was aimed to investigate whether central or peripheral block applications are preferred in percutaneous nephrolithotomy, and the need for intraoperative and postoperative analgesics in patients.In addition, it was aimed to investigate whether there was a change in analgesic consumption, recovery and pain level, and hospital stay in patients who were given general anesthesia or regional anesthesia, in a multicentric observational manner.
- Conditions
- Percutaneous Nephrolithotomy
- Being tested
- The anesthesia and analgesia technique preferred by the anesthetist will be recorded.
- Keywords
- general anesthesia, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The anesthesia and analgesia technique preferred by the anesthetist will be recorded.Other
In the study, the anesthesia method applied by blind anesthesiologists in the peroperative period, the drugs or techniques used for analgesia will be recorded and their effects on the postoperative period and hospital stay will be examined.There will be no intervention in the perioperative and postoperative process.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Patients undergoing regional anesthesia were studied. It can be in the form of combined spinal epidural or epidural anesthesia. Receives: Other: The anesthesia and analgesia technique preferred by the anesthetist will be recorded. | |
| Group 2 | Patients in whom general anesthesia and iv analgesic methods are preferred are in this group. Receives: Other: The anesthesia and analgesia technique preferred by the anesthetist will be recorded. | |
| Group 3 | Patients who prefer peripheral block under general anesthesia and ultrasound are in this group. Receives: Other: The anesthesia and analgesia technique preferred by the anesthetist will be recorded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scala (VAS)
Postoperative pain levels with Visual analog Scale (VAS):Between 0 and 10 points is chosen by the patients.
0 is no pain, 10 is excessive pain.
Measured: 1 days after the surgery
Secondary outcomes (1)
Hospital stay
The time elapsed from the patients to the discharge after the operation will be recorded from the files as hours.
Measured: after the surgery to the discharge time until 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start1 Mar 2021
- Primary completion31 Dec 2021
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous NephrolithotomyStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tugba Onur
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Tugba Onur, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Şeyda Efsun ŞE Özgünay, Assoc Prof, Principal investigator, Bursa Yuksek Ihtisas Training and Research HospitalSerra S Topal, MD, Study chair, Bursa Yuksek Ihtisas Training and Research HospitalSedat S Öner, Assoc Prof, Study chair, Bursa Yuksek Ihtisas Training and Research HospitalSalim S Zengin, MD, Study chair, Bursa Yuksek Ihtisas Training and Research HospitalŞermin Ş Eminoğlu, MD, Study chair, Bursa Yuksek Ihtisas Training and Research HospitalTuğba T Onur, MD, Study chair, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467878
- Sponsor's protocol ID
- SBÜ Bursa Hastanesi
- Status last verified
- Jul 2022
- First submitted
- 15 Apr 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Anesthesia on Perioperative Pain Level and Analgesic Effect in Patients With Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT05467878
- Acronym / sponsor ID
- SBÜ Bursa Hastanesi
- Conditions
- Percutaneous Nephrolithotomy
- Keywords
- general anesthesia, postoperative pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Tugba OnurOther government
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 21 Jul 2022 (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.
It is aimed to determine the ideal application by determining the effect of different anesthesia methods applied in percutaneous nephrolithotomy surgeries on analgesic consumption and pain level.
Detailed description
Different anesthesia methods are used in percutaneous nephrolithotomy.In addition to traditional analgesia methods such as intravenous paracetamol, NSAIDs, opioids, various methods such as epidiural analgesia or blocks added to general anesthesia are used.In this study, it was aimed to investigate whether central or peripheral block applications are preferred in percutaneous nephrolithotomy, and the need for intraoperative and postoperative analgesics in patients.In addition, it was aimed to investigate whether there was a change in analgesic consumption, recovery and pain level, and hospital stay in patients who were given general anesthesia or regional anesthesia, in a multicentric observational manner.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Other: The anesthesia and analgesia technique preferred by the anesthetist will be recorded.Patients undergoing regional anesthesia were studied. It can be in the form of combined spinal epidural or epidural anesthesia. |
| Group 2 | – | Other: The anesthesia and analgesia technique preferred by the anesthetist will be recorded.Patients in whom general anesthesia and iv analgesic methods are preferred are in this group. |
| Group 3 | – | Other: The anesthesia and analgesia technique preferred by the anesthetist will be recorded.Patients who prefer peripheral block under general anesthesia and ultrasound are in this group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 600 patients
Key inclusion criteria (2 listed)
- patient giving consent
- accessing patient information
Key exclusion criteria (1 listed)
- missing information in the patient file
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The anesthesia and analgesia technique preferred by the anesthetist will be recorded.In the study, the anesthesia method applied by blind anesthesiologists in the peroperative period, the drugs or techniques used for analgesia will be recorded and their effects on the postoperative period and hospital stay will be examined.There will be no intervention in the perioperative and postoperative process. | Other | Group 2, Group 3, Group I |
Primary outcome
Visual Analog Scala (VAS)
Time frame: 1 days after the surgery
Postoperative pain levels with Visual analog Scale (VAS):Between 0 and 10 points is chosen by the patients. 0 is no pain, 10 is excessive pain.
1 secondary outcome
Hospital stay
Time frame: after the surgery to the discharge time until 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Percutaneous Nephrolithotomy
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Effect of a Low-Dose Ketamine-Dexmedetomidine-Based Opioid-Sparing Anesthesia Protocol on Postoperative Quality of Recovery After Percutaneous Nephrolithotomy
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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. This study is not recruiting at the moment.
Şeyda Efsun ŞE Özgünay, Assoc Prof principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
Serra S Topal, MD study chair
Bursa Yuksek Ihtisas Training and Research Hospital
Sedat S Öner, Assoc Prof study chair
Bursa Yuksek Ihtisas Training and Research Hospital
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 Percutaneous Nephrolithotomy, run by Tugba Onur 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 21 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scala (VAS) (time frame: 1 days after the surgery). 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 21 Jul 2022.