NCT05467878

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 21, 2022

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

10 months

First QC Date

April 15, 2022

Last Update Submit

July 18, 2022

Conditions

Keywords

general anesthesiapostoperative pain

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 days after the surgery

Secondary Outcomes (1)

  • Hospital stay

    after the surgery to the discharge time until 10 days

Study Arms (3)

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.

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.

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.

Interventions

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 2Group 3Group I

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

600 patients

You may qualify if:

  • patient giving consent
  • accessing patient information

You may not qualify if:

  • missing information in the patient file

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa YIEAH

Bursa, Yildirim, 16600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Şeyda Efsun ŞE Özgünay, Assoc Prof

    Bursa Yuksek Ihtisas Training and Research Hospital

    PRINCIPAL INVESTIGATOR
  • Serra S Topal, MD

    Bursa Yuksek Ihtisas Training and Research Hospital

    STUDY CHAIR
  • Sedat S Öner, Assoc Prof

    Bursa Yuksek Ihtisas Training and Research Hospital

    STUDY CHAIR
  • Salim S Zengin, MD

    Bursa Yuksek Ihtisas Training and Research Hospital

    STUDY CHAIR
  • Şermin Ş Eminoğlu, MD

    Bursa Yuksek Ihtisas Training and Research Hospital

    STUDY CHAIR
  • Tuğba T Onur, MD

    Bursa Yuksek Ihtisas Training and Research Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

April 15, 2022

First Posted

July 21, 2022

Study Start

March 1, 2021

Primary Completion

December 31, 2021

Study Completion

January 15, 2022

Last Updated

July 21, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations