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

This study has suspended participant recruitment.
(Study was stopped because of ineffectiveness of one investigated Drug)
University of Schleswig-Holstein
Information provided by:
Medical University of Vienna Identifier:
First received: April 1, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
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.

Pain Cesarean Section

Study Type: Observational
Study Design: 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-

Resource links provided by NLM:

Further study details as provided by Medical University of Vienna:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 120
Study Start Date: October 2008
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
60 women after elective cesarian section
60 women after elective cesarian section

  Show Detailed Description


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Prof. Dr. Stephan Kettner, Department of Anesthesiology, General Inensive Care and Pain Control Identifier: NCT00873743     History of Changes
Other Study ID Numbers: 31121976-3
Tramal 50mg kapseln 17.688
Zaldiar 37,5mg/325mg
Study First Received: April 1, 2009
Last Updated: April 1, 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 processed this record on September 20, 2017