NCT02375607

Brief Summary

The purpose of this study is to determine the correlation between preoperative algometer score and the amount of postoperative analgesic consumption. The algometer score of the patients will be recorded in the preoperative period. In postoperative period, the analgesic consumption rate will record and compare with the algometer score.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2012

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 2, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

March 2, 2015

Status Verified

February 1, 2015

Enrollment Period

3.2 years

First QC Date

February 10, 2015

Last Update Submit

February 24, 2015

Conditions

Pain

Keywords

Pain management

Outcome Measures

Primary Outcomes (1)

  • Algometer score

    Score obtained from the Algometer device

    In one hour before the operation up to 3 years

Secondary Outcomes (1)

  • Analgesic consumption

    In the first 24 hours after the operation up to 3 years

Study Arms (1)

Algometer

OTHER

Algometer used patients

Device: Algometer

Interventions

AlgometerDEVICE

Algometer performed patients

Also known as: J-Tech Commander - Algometer
Algometer

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients those undergo septoplasty or septorhinoplasty

You may not qualify if:

  • Hypertension
  • Diabetes mellitus type 1 or 2
  • Continuous use of analgesics
  • Patients whose do not accept to participate in the study
  • Patients those reoperated for bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa University

Tokat Province, 60200, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Hsu YW, Somma J, Hung YC, Tsai PS, Yang CH, Chen CC. Predicting postoperative pain by preoperative pressure pain assessment. Anesthesiology. 2005 Sep;103(3):613-8. doi: 10.1097/00000542-200509000-00026.

    PMID: 16129988BACKGROUND

MeSH Terms

Conditions

PainAgnosia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • ZIYA KAYA, Assoc.Prof.

    Gaziosmanpasa University, Medical Faculty, Department of Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ZIYA KAYA, Assoc.Prof.

CONTACT

+905534765063zkayaahz@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, MD

Study Record Dates

First Submitted

February 10, 2015

First Posted

March 2, 2015

Study Start

February 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

March 2, 2015

Record last verified: 2015-02

Locations

TU(1)