Superiority Study for Pain Treatment After Cesarean

October 28, 2016 updated by: Max Dieterich

A Randomized Controlled Trial: Pain Management After Cesarean Section: Oxycodon vs. Intravenous Piritramide

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pain management after cesarean is an important topic for women. Pain during and after surgery is their greatest concern.

After surgery quick mobilization is important to take care of the newborn. When using a patient controlled analgesia (PCA) device mobilization is limited and women can not meet their expectations to take care of the newborn. Oral analgesia in comparison offers superior patient satisfaction.

This trial was conducted to investigate the effectiveness of both treatment options and improve patients pain management and overall content after cesarean.

Study Type

Interventional

Enrollment (Actual)

239

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • MV
      • Rostock, MV, Germany, 18055
        • University of Rostock, Department of Obstetrics and Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Study participation was offered to all pts. aged > 18 years in labor and delivery for elective or unplanned secondary cesarean in the 37th or higher week of gestation.

Inclusion Criteria:

  • cesarean in spinal anesthesia,
  • no history of opioid or metamizol treatment
  • written consent
  • ability to use a Patient-controlled analgesia device

Exclusion Criteria:

  • cesarean in general anaesthesia
  • use of peridural catheter for pre-, peri- or post cesarean analgesia
  • additional post cesarean metamizol use
  • allergy/hypersensitivity to morphine, oxycodon, acetaminophen or ibuprofen
  • chronic use of general anaesthesia
  • history of known pain syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxycodon
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.
Active Comparator: Patient controlled analgesia (PCA) device with Pritramid
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of Pain Scores on the Visual Analog Scale
Time Frame: Pain level was evaluated before therapy (2h after CS), 12h, 24h, 32h, 40h, 48 and 72h after CS.

The primary outcome measure was the change in patients assessment of pain after cesarean (CS) from baseline.

For pain assessment a visual analog scale (VAS) was used. Women were asked to quantify pain using an eleven point numerical rating score from 0 to 10, with 0 indicating no pain, and 10 the worst pain.

Single value were calculated (averaged).
Pain level was evaluated before therapy (2h after CS), 12h, 24h, 32h, 40h, 48 and 72h after CS.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subgroups
Time Frame: 6 month
Secondary Outcome Measures were to identify subgroups in benefit of either therapy.
6 month
Side Effects
Time Frame: 6 month
Evaluation of side effects
6 month
Mobilisation
Time Frame: 6 month
Evaluation of time to post surgical mobilization
6 month
Costs
Time Frame: 6 month
Evaluation costs between groups
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Max Dieterich

Collaborators

University of Rostock

Investigators

  • Principal Investigator: Max Dieterich, MD, University of Rostock, Department of Obstetrics and Gynecology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

April 27, 2010

First Submitted That Met QC Criteria

May 3, 2010

First Posted (Estimate)

May 4, 2010

Study Record Updates

Last Update Posted (Estimate)

December 12, 2016

Last Update Submitted That Met QC Criteria

October 28, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KJ-2009-MD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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