The Efficacy of Analgesic Methods After Caesarean SectionPCAPSNCT02062320
Establishment and Evaluation of a Post Caesarean Acute Pain Service (PCAPS)
An observational study of The Efficacy of Analgesic Methods After Caesarean Section, run by Brno University Hospital at 1 site in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- The Efficacy of Analgesic Methods After Caesarean Section
- How many people
- 407 participants
- Where
- 1 siteCzechia
- Study dates
- Oct 2009to Oct 2011
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: We evaluated all patients undergoing delivery via Caesarean Section under anaesthesia in the period 10/2009 - 10/2011.
Who may be able to join
- Caesarean Section performed from October 2009 to October 2011 (study period)
- completed "Evaluation of postoperative analgesia after Caesarean Section" form.
Who cannot join
- Not completed "Standard Evaluation of postoperative analgesia after Caesarean Section" form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Keywords
- Acute Pain Service, postoperative analgesia, Caesarean Section, non-opioid analgesia, opioid analgesia, epidural analgesia
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 |
|---|---|---|
| PRE-PCAPS | Parturients who underwent delivery by Caesarean Section in the period October 2009 - September 2010 | |
| POST-PCAPS | Parturients who underwent delivery by Caesarean Section in the period November 2010 - October 2011. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
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.
Measured: 72 hours after Caesarean Section (CS)
Secondary outcomes (3)
VAS score above 4
unsatisfactory pain relief
Measured: 72 hours after CS
Additional Analgesic Requests (AAR) Count
Comparison of the average value of the AARs count in groups in the first 72 hours after CS
Measured: 72 hours after CS
Analgesia related complication Rate
Analgesia related complications including hypotension, hypertension, tachycardia, bradycardia, hypoventilation were recorded.
Measured: 72 hours after CS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startOct 2009
- Primary completionOct 2011
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 The Efficacy of Analgesic Methods After Caesarean SectionStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Petr Štourač, MD, Ph.D., Study director, Brno Faculty Hospital, departement of anesthesiology and intensive care medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062320
- Sponsor's protocol ID
- NT13906-4/2012
- Acronym
- PCAPS
- Status last verified
- Feb 2014
- First submitted
- 11 Feb 2014
- Last updated
- 13 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 16798441Ismail 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.
PubMed 22345943Stourac 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.
PubMed 23128818
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Evaluation of a Post Caesarean Acute Pain Service
- ClinicalTrials.gov ID
- NCT02062320
- Acronym / sponsor ID
- PCAPS / NT13906-4/2012
- Keywords
- Acute Pain Service, postoperative analgesia, Caesarean Section, non-opioid analgesia, opioid analgesia, epidural analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2011 (actual)
- First posted
- 13 Feb 2014 (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 compare the efficacy of analgesic methods after Caesarean Section before and after Post Caesarean Acute Pain Service establishing.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRE-PCAPS | – | –Parturients who underwent delivery by Caesarean Section in the period October 2009 - September 2010 |
| POST-PCAPS | – | –Parturients who underwent delivery by Caesarean Section in the period November 2010 - October 2011. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We evaluated all patients undergoing delivery via Caesarean Section under anaesthesia in the period 10/2009 - 10/2011.
Key inclusion criteria (2 listed)
- Caesarean Section performed from October 2009 to October 2011 (study period)
- completed "Evaluation of postoperative analgesia after Caesarean Section" form.
Key exclusion criteria (1 listed)
- Not completed "Standard Evaluation of postoperative analgesia after Caesarean Section" form.
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
Visual Analogue Scale (VAS)
Time frame: 72 hours after Caesarean Section (CS)
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.
3 secondary outcomes
VAS score above 4
Time frame: 72 hours after CS
Additional Analgesic Requests (AAR) Count
Time frame: 72 hours after CS
Analgesia related complication Rate
Time frame: 72 hours after CS
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 13 Feb 2014.
- Background: PubMed 16798441Pan 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.
- Background: PubMed 22345943Ismail 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.
- Background: PubMed 23128818Stourac 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.
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.
Petr Štourač, MD, Ph.D. study director
Brno Faculty Hospital, departement of anesthesiology and intensive care medicine
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 The Efficacy of Analgesic Methods After Caesarean Section, run by Brno University Hospital at 1 site in Czechia.
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 2 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 13 Feb 2014. 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 Czechia. 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?
Visual Analogue Scale (VAS) (time frame: 72 hours after Caesarean Section (CS)). 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 NCT02062320, 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 13 Feb 2014.