NCT03148951

Brief Summary

In the planned study the investigators want to evaluate the relation between postoperative complications and minor/ major morbidities, mortality and Mean Platelet Volume (MPV) and Neutrophil/ lymphocyte (N/L) ratio.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
754

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

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

First Submitted

Initial submission to the registry

May 2, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 11, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 28, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

January 13, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

May 2, 2017

Last Update Submit

January 12, 2023

Conditions

Keywords

MPVNLRPostoperative pain

Outcome Measures

Primary Outcomes (1)

  • postoperative VAS (visual analogue scale) score

    postoperative visual analog scale score for pain evaluation 0,10,20,30,40,50,60,70,80,90,100)

    VAS score at postoperative twenty-forth hours will be evaluated

Secondary Outcomes (2)

  • analgesic drugs

    total dose of analgesic drugs required at twenty four hours will be evaluated

  • postoperative major morbidities

    at postoperative first, sixth, twelfth and twenty-forth hours

Other Outcomes (1)

  • postoperative side effects

    at postoperative first, sixth, twelfth and twenty-forth hours

Study Arms (4)

Group 1

Group 1: patients receiving general anesthesia and having a postoperative pain VAS score equal to or below 50 at 1st, 6th, 12th nd 24th hours the pain sores will be evaluated at 4 time intervals and so the number of patients in every group may change at every time interval.

Group 2

Group 2: patients receiving general anesthesia and having a postoperative pain VAS score equal to or above 60 at 1st, 6th, 12th nd 24th hours the pain sores will be evaluated at 4 time intervals and so the number of patients in every group may change at every time interval.

Group 3

Group 3: patients receiving regional (spinal) anesthesia and having a postoperative pain VAS score equal to or below 50 at 1st, 6th, 12th nd 24th hours the pain sores will be evaluated at 4 time intervals and so the number of patients in every group may change at every time interval.

Group 4

Group 4: patients receiving spinal anesthesia and having a postoperative pain VAS score equal to or above 60 at 1st, 6th, 12th nd 24th hours the pain sores will be evaluated at 4 time intervals and so the number of patients in every group may change at every time interval.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive patients undergoing knee arthroplasty in 3 years period with general or spinal anesthesia.

You may qualify if:

  • knee arthroplasty patients with general or spinal anesthesia.

You may not qualify if:

  • patients not giving consent
  • reoperations
  • patients having inflammatory disease
  • infection in the knee
  • sepsis
  • bleeding disorders
  • hematologic diseases,
  • using steroids.
  • trauma
  • fracture patients,
  • bilateral knee prothesis
  • combined surgery procedures
  • patients needing perioperative transfusions
  • uncooperative patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AkdenizU

Antalya, 07058, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Ilker o Aycan, asso prof

    Akdeniz University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

May 2, 2017

First Posted

May 11, 2017

Study Start

June 28, 2017

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

January 13, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations