Establishment and Evaluation of a Post Caesarean Acute Pain Service (PCAPS) (PCAPS)
February 12, 2014 updated by: Petr Štourač, MD, Brno University Hospital
Establishment and Evaluation of a Post Caesarean Acute Pain Service
The aim of this study is to compare the efficacy of analgesic methods after Caesarean Section before and after Post Caesarean Acute Pain Service establishing.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
407
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jihomoravský Kraj
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Brno, Jihomoravský Kraj, Czech Republic, 625 00
- Faculty Hospital Brno
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
We evaluated all patients undergoing delivery via Caesarean Section under anaesthesia in the period 10/2009 - 10/2011.
Description
Inclusion Criteria:
- Caesarean Section performed from October 2009 to October 2011 (study period)
- completed "Evaluation of postoperative analgesia after Caesarean Section" form.
Exclusion Criteria:
- Not completed "Standard Evaluation of postoperative analgesia after Caesarean Section" form.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
|---|
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PRE-PCAPS
Parturients who underwent delivery by Caesarean Section in the period October 2009 - September 2010
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POST-PCAPS
Parturients who underwent delivery by Caesarean Section in the period November 2010 - October 2011.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Visual Analogue Scale (VAS)
Time Frame: 72 hours after Caesarean Section (CS)
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Comparison of pain intensity (Visual Analogue Scale (VAS)) during the postoperative period (72 hours) between the two groups according to postoperative analgesic method and method of anaesthesia.
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72 hours after Caesarean Section (CS)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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VAS score above 4
Time Frame: 72 hours after CS
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unsatisfactory pain relief
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72 hours after CS
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Additional Analgesic Requests (AAR) Count
Time Frame: 72 hours after CS
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Comparison of the average value of the AARs count in groups in the first 72 hours after CS
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72 hours after CS
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Analgesia related complication Rate
Time Frame: 72 hours after CS
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Analgesia related complications including hypotension, hypertension, tachycardia, bradycardia, hypoventilation were recorded.
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72 hours after CS
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Petr Štourač, MD, Ph.D., Brno Faculty Hospital, departement of anesthesiology and intensive care medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Pan PH. Post cesarean delivery pain management: multimodal approach. Int J Obstet Anesth. 2006 Jul;15(3):185-8. doi: 10.1016/j.ijoa.2006.04.004. No abstract available.
- Ismail S, Shahzad K, Shafiq F. Observational study to assess the effectiveness of postoperative pain management of patients undergoing elective cesarean section. J Anaesthesiol Clin Pharmacol. 2012 Jan;28(1):36-40. doi: 10.4103/0970-9185.92432.
- Stourac P, Suchomelova H, Stodulkova M, Huser M, Krikava I, Janku P, Haklova O, Hakl L, Stoudek R, Gal R, Sevcik P. Comparison of parturient - controlled remifentanil with epidural bupivacain and sufentanil for labour analgesia: randomised controlled trial. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2014 Jun;158(2):227-32. doi: 10.5507/bp.2012.073. Epub 2012 Oct 31.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
February 11, 2014
First Submitted That Met QC Criteria
February 12, 2014
First Posted (Estimate)
February 13, 2014
Study Record Updates
Last Update Posted (Estimate)
February 13, 2014
Last Update Submitted That Met QC Criteria
February 12, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NT13906-4/2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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