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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02375607
Other study ID # 26/07/2011-195
Secondary ID
Status Recruiting
Phase N/A
First received February 10, 2015
Last updated February 24, 2015
Start date February 2012
Est. completion date May 2015

Study information

Verified date February 2015
Source Tokat Gaziosmanpasa University
Contact ZIYA KAYA, Assoc.Prof.
Phone +905534765063
Email zkayaahz@gmail.com
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Interventional

Clinical Trial 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.


Description:

The aim of this study is to define the correlation between preoperative algometer score and the analgesic consumption rate. A total of 80 patients whose undergo septoplasty or septorhinoplasty will be included in this study. After preoperative examination, a positive pressure using algometer device will be performed until minimal pain is felt. In postoperative period, the amount of analgesic consumption of the patient will record and compare with the algometer score.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Patients those undergo septoplasty or septorhinoplasty

Exclusion Criteria:

- 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening


Related Conditions & MeSH terms


Intervention

Device:
Algometer
Algometer performed patients

Locations

Country Name City State
Turkey Gaziosmanpasa University Tokat

Sponsors (1)

Lead Sponsor Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Algometer score Score obtained from the Algometer device In one hour before the operation up to 3 years No
Secondary Analgesic consumption The amount of analgesic consumption In the first 24 hours after the operation up to 3 years No
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