NCT00873743

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2009

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

April 2, 2009

Status Verified

April 1, 2009

Enrollment Period

7 months

First QC Date

April 1, 2009

Last Update Submit

April 1, 2009

Conditions

PainCesarean Section

Keywords

lower pain intensity with combination drug after cesarian section in first 48h postoperatively

Outcome Measures

Primary Outcomes (1)

  • VAS-Score at leg rising

    4h, 8h, 24h 48h postoperatively

Secondary Outcomes (1)

  • VAS-Score at rest, nausea, vomitus, sedation, general satisfaction

    4h, 8,h, 24h, 48h postoperatively

Study Arms (2)

1

60 women after elective cesarian section

2

60 women after elective cesarian section

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Female patients postoperatively after cesarian section

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Vienna

Vienna, Vienna, 1080, Austria

Location

Biospecimen

Retention: SAMPLES WITH DNA

CYP P450 2D6 metabolizer status

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stephan Kettner, MD, Prof

    Department of Anesthesiology, General Intensive Care and Pain Control, Medical University Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 1, 2009

First Posted

April 2, 2009

Study Start

October 1, 2008

Primary Completion

May 1, 2009

Study Completion

October 1, 2009

Last Updated

April 2, 2009

Record last verified: 2009-04

Locations

AU(1)