PerfusionNCT03151369
Visual Pain Score and Perfusion Index in Postoperative Patients
A study testing Morphine in people with Perfusion, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
The relationship between visual pain score and perfusion index in postoperative patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Perfusion
- What is being tested?
- Morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Apr 2017to 19 Feb 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent surgery with general anesthesia
Who cannot join
- Patients with caesarean section, pregnancy story and chronic pain
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa University
Tokat Province, 60200
About this study
Official title: The Relationship Between Visual Pain Score and Perfusion Index in Postoperative Patients
The relationship between visual pain score and perfusion index in postoperative patients.
Read the detailed description
The patients' operated with general anesthesia and who had visual pain score(VAS) above 3 will be measured postoperatively perfusion index. .If the VAS score is above 3, 2 mg of morphine will be made. When the VAS score is below 3, the perfusion index will be measured again.Thus, the changes between vas and perfusion index will be measured.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Also called opioid analgesic
patients with the visual analog scale over 3 will receive morphine
| Study group | Role | What they receive |
|---|---|---|
| Morphine | Other | patients with the visual analog scale over 3 will receive morphine Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion index Perfusion index
Measurement of perfusion on the right ring finger
Measured: two times in one day
Secondary outcomes (1)
visual analog scale
measurement of pain intensity
Measured: two times in one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start18 Apr 2017
- Primary completion20 Jan 2018
- Study completion19 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerfusionStudies 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
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Tapar, Tokat Gaziosmanpasa University
- Investigators
- Hakan Tapar, Principal investigator, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151369
- Sponsor's protocol ID
- 17-KAEK-007
- Status last verified
- Feb 2018
- First submitted
- 18 Apr 2017
- Last updated
- 20 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Visual Pain Score and Perfusion Index in Postoperative Patients
- ClinicalTrials.gov ID
- NCT03151369
- Acronym / sponsor ID
- 17-KAEK-007
- Conditions
- Perfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 20 Jan 2018 (actual)
- Study completion
- 19 Feb 2018 (actual)
- First posted
- 12 May 2017 (actual)
- 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 relationship between visual pain score and perfusion index in postoperative patients.
Detailed description
The patients' operated with general anesthesia and who had visual pain score(VAS) above 3 will be measured postoperatively perfusion index. .If the VAS score is above 3, 2 mg of morphine will be made. When the VAS score is below 3, the perfusion index will be measured again.Thus, the changes between vas and perfusion index will be measured.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Morphine | Other | Drug: Morphinepatients with the visual analog scale over 3 will receive morphine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who underwent surgery with general anesthesia
Key exclusion criteria (1 listed)
- Patients with caesarean section, pregnancy story and chronic pain
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 |
|---|---|---|
| MorphineAlso: opioid analgesicpatients with the visual analog scale over 3 will receive morphine | Drug | Morphine |
Primary outcome
Perfusion index Perfusion index
Time frame: two times in one day
Measurement of perfusion on the right ring finger
1 secondary outcome
visual analog scale
Time frame: two times in one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Perfusion
Not yet recruiting
Hypothermic Oxygenated Machine PErfusion During Ex-vivo SPLITting in Liver Pediatric Transplantation (HOPESPLIT)
Pediatric Liver Transplantation
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Recruiting
Perfusion Index for Postoperative Pain Assessment in Pediatric Adenotonsillectomy
Postoperative Pain, Adenotonsillectomy
RecruitingObservational study
Hemodynamic Evaluation and Assessment of DIRECT myocaRdial and Sublingual Capillary Perfusion in Thoracic Surgery Patients on Cardiopulmonary Bypass
Microcirculatory Perfusion
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.
Hakan Tapar principal investigator
Assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphine in people with Perfusion, 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 1 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: finished, as of the sponsor's last update on 20 Feb 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfusion index Perfusion index (time frame: two times in one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2018.