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Superiority Study for Pain Treatment After Cesarean

NCT01115101 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2016-12-12

Study results available
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Summary

The purpose of this study is to investigate adequate pain treatment for patients after cesarean. In this study oral opioids were compared to intravenous opioids as they are supposed to provide superior pain control.

Conditions

Interventions

DRUG

Oral Oxycodon

Patients assigned to the oral analgesia group received 20mg oxycodon at fixed intervals: 2 hours (h) and between 12h and 14h after cesarean.

DRUG

Piritramid

Patients assigned to the PCA group received a single use intravenous PCA device (Vygon, Medical Products, Aachen, Germany) with a 30ml deposit of 9% sodium chloride solution containing 60mg piritramide. Bolus injection of 0.5ml was administered by the patient herself if needed, with a lock out interval of 5 minutes Patients assigned to the oral analgesia group received 20mg oxycodon at fixed intervals: 2 hours (h) and between 12h and 14h after cesarean. The PCA was discontinued after 24 hours or earlier if demanded.

Sponsors & Collaborators

  • University of Rostock

    collaborator OTHER

  • Max Dieterich

    lead OTHER

Principal Investigators

  • Max Dieterich, MD · University of Rostock, Department of Obstetrics and Gynecology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01115101 on ClinicalTrials.gov