PainNCT02375607
Could Algometric Assessment be Effective to Adjust Postoperative Analgesic Requirement?
A study testing Algometer in people with Pain, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Algometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2012to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients those undergo septoplasty or septorhinoplasty
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziosmanpasa University
Tokat Province, 60200
ZIYA KAYA, Assoc.Prof., +905534765063, zkayaahz@gmail.com
About this study
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Algometer
- Keywords
- Pain management
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlgometerDevice
Also called J-Tech Commander - Algometer
Algometer performed patients
| Study group | Role | What they receive |
|---|---|---|
| Algometer | Other | Algometer used patients Receives: Device: Algometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Algometer score
Score obtained from the Algometer device
Measured: In one hour before the operation up to 3 years
Secondary outcomes (1)
Analgesic consumption
The amount of analgesic consumption
Measured: In the first 24 hours after the operation up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startFeb 2012
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziya Kaya, Tokat Gaziosmanpasa University
- Investigators
- ZIYA KAYA, Assoc.Prof., Principal investigator, Gaziosmanpasa University, Medical Faculty, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375607
- Sponsor's protocol ID
- 26/07/2011-195
- Status last verified
- Feb 2015
- First submitted
- 10 Feb 2015
- Last updated
- 2 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16129988
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Could Algometric Assessment be Effective to Adjust Postoperative Analgesic Requirement?
- ClinicalTrials.gov ID
- NCT02375607
- Acronym / sponsor ID
- 26/07/2011-195
- Conditions
- Pain
- Keywords
- Pain management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Algometer | Other | Device: AlgometerAlgometer used patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients those undergo septoplasty or septorhinoplasty
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlgometerAlso: J-Tech Commander - AlgometerAlgometer performed patients | Device | Algometer |
Primary outcome
Algometer score
Time frame: In one hour before the operation up to 3 years
Score obtained from the Algometer device
1 secondary outcome
Analgesic consumption
Time frame: In the first 24 hours after the operation up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2015.
- Background: PubMed 16129988Hsu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ZIYA KAYA, Assoc.Prof. principal investigator
Gaziosmanpasa University, Medical Faculty, Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algometer in people with Pain, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ZIYA KAYA, Assoc.Prof. (+905534765063, zkayaahz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Algometer score (time frame: In one hour before the operation up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02375607, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2015.