Establishment and Evaluation of a Post Caesarean Acute Pain Service (PCAPS)

The Efficacy of Analgesic Methods After Caesarean Section Clinical Trial

— PCAPS  

Official title:

Establishment and Evaluation of a Post Caesarean Acute Pain Service

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062320
• Other study ID #: NT13906-4/2012
• Status: Completed
• Phase: N/A
• First received: February 11, 2014
• Last updated: February 12, 2014
• Start date: October 2009

Study information

• Verified date: February 2014
• Source: Brno University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Institute of Biostatistics and Analyses, Masaryk University - University Campus Bohunice (Kamenice 126/3), Brno: Czech Republic
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 407
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Pain
• The Efficacy of Analgesic Methods After Caesarean Section

Locations

Country	Name	City	State
Czech Republic	Faculty Hospital Brno	Brno	Jihomoravský Kraj

Sponsors (1)

Lead Sponsor	Collaborator
Brno University Hospital

Country where clinical trial is conducted

Czech Republic, 

References & Publications (3)

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. — View Citation

Pan PH. Post cesarean delivery pain management: multimodal approach. Int J Obstet Anesth. 2006 Jul;15(3):185-8. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	72 hours after Caesarean Section (CS)	No
Secondary	VAS score above 4	unsatisfactory pain relief	72 hours after CS	No
Secondary	Additional Analgesic Requests (AAR) Count	Comparison of the average value of the AARs count in groups in the first 72 hours after CS	72 hours after CS	No
Secondary	Analgesia related complication Rate	Analgesia related complications including hypotension, hypertension, tachycardia, bradycardia, hypoventilation were recorded.	72 hours after CS	Yes