The Effect of Anesthesia on Pain in Percutaneous Nephrolithotomy

July 18, 2022 updated by: Tugba Onur

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Yildirim
      • Bursa, Yildirim, Turkey, 16600
        • Bursa YIEAH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

600 patients

Description

Inclusion Criteria:

  • patient giving consent
  • accessing patient information

Exclusion Criteria:

  • missing information in the patient file

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group I
Patients undergoing regional anesthesia were studied. It can be in the form of combined spinal epidural or epidural anesthesia.
Other: 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.
Group 2
Patients in whom general anesthesia and iv analgesic methods are preferred are in this group.
Other: 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.
Group 3
Patients who prefer peripheral block under general anesthesia and ultrasound are in this group.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 days after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital stay
Time Frame: after the surgery to the discharge time until 10 days
The time elapsed from the patients to the discharge after the operation will be recorded from the files as hours.
after the surgery to the discharge time until 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tugba Onur

Investigators

  • Principal Investigator: Şeyda Efsun ŞE Özgünay, Assoc Prof, Bursa Yüksek İhtisas Education and Research Hospital
  • Study Chair: Serra S Topal, MD, Bursa Yüksek İhtisas Education and Research Hospital
  • Study Chair: Sedat S Öner, Assoc Prof, Bursa Yüksek İhtisas Education and Research Hospital
  • Study Chair: Salim S Zengin, MD, Bursa Yüksek İhtisas Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2021

Primary Completion (ACTUAL)

December 31, 2021

Study Completion (ACTUAL)

January 15, 2022

Study Registration Dates

First Submitted

April 15, 2022

First Submitted That Met QC Criteria

July 18, 2022

First Posted (ACTUAL)

July 21, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBÜ Bursa Hastanesi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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