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)
Sponsor:
Collaborator:
University of Schleswig-Holstein
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00873743
First received: April 1, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • VAS-Score at rest, nausea, vomitus, sedation, general satisfaction [ Time Frame: 4h, 8,h, 24h, 48h postoperatively ] [ Designated as safety issue: Yes ]

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)
Groups/Cohorts
1
60 women after elective cesarian section
2
60 women after elective cesarian section

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Female patients postoperatively after cesarian section

Criteria

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 ClinicalTrials.gov identifier: NCT00873743

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

No publications provided

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
Study First Received: April 1, 2009
Last Updated: April 1, 2009
Health Authority: Austria: Ethikkommission

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

Additional relevant MeSH terms:
Acetaminophen
Tramadol
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on August 28, 2014