NCT06942650

Brief Summary

The goal of this observational study is to learn about the relationship between postoperative pain and tourniquet-induced oxidative damage in adults undergoing orthopedic knee arthroscopy surgery.The goal of this observational study is to learn about the relationship between postoperative pain and tourniquet-induced oxidative damage in adults undergoing orthopedic knee arthroscopy surgery. The main question it aims to answer is: Does anesthetic agents used will affect tourniquet-related oxidative stress and postoperative pain ?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Typical duration 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

January 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

2 years

First QC Date

March 18, 2025

Last Update Submit

April 16, 2025

Conditions

Keywords

Hypoxia-inducible factor alfatourniquet painanesthesiaischemiapostoperative pain

Outcome Measures

Primary Outcomes (1)

  • To observe the relation between somatic oximeter values and oxidative stress parameters.

    To observe the correlation between INVOS™ 5100C Cerebral/Somatic Oximeter measurements(rSO2) (% value) and oxidative stress parameters \[ Human hypoxia-inducible factor 1α(HIF-1α) ELISA kit (pg/L), Human decay-accelerating factor(DAF/CD55)ELISA (pg/L) \] measurements after tourniquet inflation and before tourniquet deflation.

    1 day

Secondary Outcomes (1)

  • The effect of anesthetic agents on oxidative stress parameters.

    1 day

Other Outcomes (1)

  • The effect of oxidative stress parameters on 24 hour analgesic needing

    1 day

Eligibility Criteria

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

Sixty patients aged 18-80, with ASA I-II status, who underwent knee arthroscopy were included in the study. A voluntary consent form was obtained all th e patients.

You may qualify if:

  • Patients aged 18-80 years,
  • (American society of Anesthesiologist) ASA I-II status,
  • undergoing knee arthroscopy.

You may not qualify if:

  • Diabetes mellitus,
  • advanced chronic obstructive pulmonary disease,
  • liver failure,
  • renal failure,
  • history of previous bypass,
  • hemoglobinopathies,
  • anemia,
  • hypertensive patients,
  • neurodegenerative diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İlknur SuidiyeYORULMAZ

Düzce, 81620, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeIschemia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • İlknur S YORULMAZ, Assoc. Prof.

    Duzce University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2025

First Posted

April 24, 2025

Study Start

January 1, 2022

Primary Completion

January 1, 2024

Study Completion

August 1, 2024

Last Updated

April 24, 2025

Record last verified: 2025-04

Locations