PainNCT02332395
The Evaluation of Postoperative Pain After Caesarean Section
An observational study of Pain, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of surgical priority either emergency or elective on postoperative pain in caesarean section operations. Patients whose undergo caesarean section operation are included into this study. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pain
- How many people
- 115 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2013to May 2016
- Phase
- Observational
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: individuals whose underwent caesarean section operation in terms of surgical priority whether emergency or elective
Who may be able to join
- American Society of Anesthesiologists score of 1 or 3 and 1-Emergency or 3-Emergency
Who cannot join
- Patients whose not to participate
- Patients whose have communication problems
- Patients whose have been using antipsychotic or antidepressant drugs
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa University
Tokat Province, Tokat Province, 60200
About this study
Official title: The Evaluation of Postoperative Pain After Emergency and Elective Caesarean Section Operations
The aim of this study is to determine the effect of surgical priority either emergency or elective on postoperative pain in caesarean section operations. Patients whose undergo caesarean section operation are included into this study. Patients will invite to complete the Pain Catastrophizing Scale questionnaire in preoperative period. The patients will be divided into two groups in terms of applied surgical priority whether emergency or elective. After caesarean section, patient controlled analgesia is used for pain relief. And the intensity of pain will be measured by using numerical rating scale.
Read the detailed description
Pain is the main problem of postoperative period. Postoperative analgesic consumption can be associated with physical and psychological condition of the individual. This study is aimed to investigate the effect of surgical priority either emergency or elective on postoperative pain in caesarean section operations.
Patients are invited to complete the pain catastrophizing scale questionnaire in preoperative period.
A total of 100 patients will be included into the study. Patients are divided into two groups in terms of surgical priority whether emergency or elective. Spinal or general anesthesia will be performed to the patients. In postoperative period, patient controlled analgesia will be applied for pain relief and numerical rating scale is used to determine the pain intensity in 1st, 2nd, 6th, 12th, 24th hours. The analgesic consumption in 24 hours will be recorded.
- Conditions
- Pain
- Keywords
- pain, pain catastrophizing, cesarean section
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Emergency caesarean section | patients whose underwent emergency caesarean section operation | |
| Elective caesarean section | patients whose underwent elective caesarean section operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of analgesics
Measured: 24 hours
Secondary outcomes (2)
numerical rating scale
Measured: 24 hours
pain catastrophizing scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startDec 2013
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 115 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, Ass.Prof, MD, Principal investigator, Gaziosmanpasa University, Medical Faculty, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332395
- Sponsor's protocol ID
- 13-KAEK-226
- Status last verified
- Apr 2017
- First submitted
- 5 Jan 2015
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Taşdemir A, Erakgün A, Nuri Deniz M, ÇertuğA . Preoperatif Bilgilendirme Yapılan Hastalarda Ameliyat öncesi ve Sonrası Anksiyete Düzeylerinin State-Trait Anxiety Inventory Test ile Karşılaştırılması. Turkish Journal Anaesthesiology and Reanimation 41(2): 44-9, 2013.
Kırdemir P, Özorak Ö. Postoperatif Ağrı ve Analjezik İhtiyacı Preoperatif Dönemde Tahmin Edilebilir mi? Turkiye Klinikleri Journal of Medical Sciences 31(4):951-9, 2011.
Hüseyinoğlu Ü, Ülker K, Temur İ, Kütük M. Elektif Sezaryen Doğum Sonrası Postoperatif Ağrı Gideriminde Meperidin ve Tramadolün Karșılaștırılması: Bir Prospektif Randomize Çalıșma. Kafkas Journal of Medical Sciences 1(2):53-56, 2011.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Postoperative Pain After Emergency and Elective Caesarean Section Operations
- ClinicalTrials.gov ID
- NCT02332395
- Acronym / sponsor ID
- 13-KAEK-226
- Conditions
- Pain
- Keywords
- pain, pain catastrophizing, cesarean section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 6 Jan 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 aim of this study is to determine the effect of surgical priority either emergency or elective on postoperative pain in caesarean section operations. Patients whose undergo caesarean section operation are included into this study. Patients will invite to complete the Pain Catastrophizing Scale questionnaire in preoperative period. The patients will be divided into two groups in terms of applied surgical priority whether emergency or elective. After caesarean section, patient controlled analgesia is used for pain relief. And the intensity of pain will be measured by using numerical rating scale.
Detailed description
Pain is the main problem of postoperative period. Postoperative analgesic consumption can be associated with physical and psychological condition of the individual. This study is aimed to investigate the effect of surgical priority either emergency or elective on postoperative pain in caesarean section operations.
Patients are invited to complete the pain catastrophizing scale questionnaire in preoperative period.
A total of 100 patients will be included into the study. Patients are divided into two groups in terms of surgical priority whether emergency or elective. Spinal or general anesthesia will be performed to the patients. In postoperative period, patient controlled analgesia will be applied for pain relief and numerical rating scale is used to determine the pain intensity in 1st, 2nd, 6th, 12th, 24th hours. The analgesic consumption in 24 hours will be recorded.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emergency caesarean section | – | –patients whose underwent emergency caesarean section operation |
| Elective caesarean section | – | –patients whose underwent elective caesarean section operation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- individuals whose underwent caesarean section operation in terms of surgical priority whether emergency or elective
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists score of 1 or 3 and 1-Emergency or 3-Emergency
Key exclusion criteria (3 listed)
- Patients whose not to participate
- Patients whose have communication problems
- Patients whose have been using antipsychotic or antidepressant drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total amount of analgesics
Time frame: 24 hours
2 secondary outcomes
numerical rating scale
Time frame: 24 hours
pain catastrophizing scale
Time frame: 1 year
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 19 Apr 2017.
- BackgroundTaşdemir A, Erakgün A, Nuri Deniz M, ÇertuğA . Preoperatif Bilgilendirme Yapılan Hastalarda Ameliyat öncesi ve Sonrası Anksiyete Düzeylerinin State-Trait Anxiety Inventory Test ile Karşılaştırılması. Turkish Journal Anaesthesiology and Reanimation 41(2): 44-9, 2013.
- BackgroundKırdemir P, Özorak Ö. Postoperatif Ağrı ve Analjezik İhtiyacı Preoperatif Dönemde Tahmin Edilebilir mi? Turkiye Klinikleri Journal of Medical Sciences 31(4):951-9, 2011.
- BackgroundHüseyinoğlu Ü, Ülker K, Temur İ, Kütük M. Elektif Sezaryen Doğum Sonrası Postoperatif Ağrı Gideriminde Meperidin ve Tramadolün Karșılaștırılması: Bir Prospektif Randomize Çalıșma. Kafkas Journal of Medical Sciences 1(2):53-56, 2011.
- Individual participant dataSharing planned: Undecided
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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.
Hakan Tapar, Ass.Prof, MD 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?
An observational study of 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 3 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 19 Apr 2017. 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?
Total amount of analgesics (time frame: 24 hours). 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 NCT02332395, which also lists 3 linked publications.
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 19 Apr 2017.