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Analgesia and Antihyperalgesia of Tramadol and Acetaminophen Per Oral After Caesarean Section

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ClinicalTrials.gov Identifier: NCT00873743
Recruitment Status : Suspended (Study was stopped because of ineffectiveness of one investigated Drug)
First Posted : April 2, 2009
Last Update Posted : April 2, 2009
University of Schleswig-Holstein
Information provided by:
Medical University of Vienna

Brief Summary:
The aim of this study is to evaluate quality of patient-controlled peroral analgesia after cesarian section using the combination of tramadol and acetaminophen. Research hypothesis is that the combination reduces pain at leg rising more than tramadol alone.

Condition or disease
Pain Cesarean Section

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 120 participants
Time Perspective: Prospective
Official Title: Postoperative Analgesia and Antihyperalgesia of Tramadol and Acetaminophen Per Oral After Caesarean Section -A Randomised Controlled Trial in Female O-Desmethyl 1 Metabolizers Identified by the Respective Gene-
Study Start Date : October 2008
Estimated Primary Completion Date : May 2009
Estimated Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

60 women after elective cesarian section
60 women after elective cesarian section

Primary Outcome Measures :
  1. VAS-Score at leg rising [ Time Frame: 4h, 8h, 24h 48h postoperatively ]

Secondary Outcome Measures :
  1. VAS-Score at rest, nausea, vomitus, sedation, general satisfaction [ Time Frame: 4h, 8,h, 24h, 48h postoperatively ]

Biospecimen Retention:   Samples With DNA
CYP P450 2D6 metabolizer status

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Female patients postoperatively after cesarian section

Inclusion Criteria:

  • 18 and 45 years
  • ASA-Status 1-2
  • BMI 19-29, that are scheduled for planned caesarean section and have given written informed consent

Exclusion Criteria:

  • Allergies or hypersensitivities to evaluated drugs
  • History of pain syndrome
  • Substance abuse
  • Preeclampsia or eclampsia
  • Deviation from standardised surgical procedure
  • Treatment with magnesium sulfate
  • Renal or hepatic impairment and deviations from the standardized anaesthetic treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00873743

Medical University Vienna
Vienna, Austria, 1080
Sponsors and Collaborators
Medical University of Vienna
University of Schleswig-Holstein
Principal Investigator: Stephan Kettner, MD, Prof Department of Anesthesiology, General Intensive Care and Pain Control, Medical University Vienna

Responsible Party: Prof. Dr. Stephan Kettner, Department of Anesthesiology, General Inensive Care and Pain Control
ClinicalTrials.gov Identifier: NCT00873743     History of Changes
Other Study ID Numbers: 31121976-3
Tramal 50mg kapseln 17.688
Zaldiar 37,5mg/325mg
First Posted: April 2, 2009    Key Record Dates
Last Update Posted: April 2, 2009
Last Verified: April 2009

Keywords provided by Medical University of Vienna:
lower pain intensity with combination drug after cesarian section in first 48h postoperatively

Additional relevant MeSH terms:
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics, Opioid
Central Nervous System Depressants