Could Algometric Assessment be Effective to Adjust Postop... | NCT02375607

Studies
Could Algometric Assessment be Effective to Adjust Postoperative Analgesic Requirement?

NCT02375607

Sponsor

Tokat Gaziosmanpasa University

Status

Unknown status

Last Update Posted

Mar 2, 2015Estimated

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Pain

Interventions

Algometer

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

May 2015Estimated

Completion Date

May 2015Estimated

First Submitted Date

Feb 10, 2015

First Submission Date that Met QC Criteria

Feb 24, 2015

First Posted Date

Mar 2, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2015

Last Update Posted Date

Mar 2, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ziya Kaya, Associate Professor, MD, Tokat Gaziosmanpasa UniversityPrincipal Investigator

Lead Sponsor

Tokat Gaziosmanpasa UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Algometer	Other	Algometer used patients	Device: Algometer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Algometer	Device	Algometer performed patients	Algometer	J-Tech Commander - Algometer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Algometer score	Score obtained from the Algometer device	In one hour before the operation up to 3 years

Secondary Outcomes

Measure	Description	Time Frame
Analgesic consumption	The amount of analgesic consumption	In the first 24 hours after the operation up to 3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ZIYA KAYA, Assoc.Prof.	Contact	+905534765063		zkayaahz@gmail.com

Overall Officials

Name	Affiliation	Role
ZIYA KAYA, Assoc.Prof.	Gaziosmanpasa University, Medical Faculty, Department of Anesthesiology and Reanimation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gaziosmanpasa University	Recruiting	Tokat Province		60200	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16129988	Background	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.

ID	Term
D010146	Pain
D000377	Agnosia

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D010468	Perceptual Disorders