Superiority Study for Pain Treatment After Cesarean

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01115101
Recruitment Status : Completed
First Posted : May 4, 2010
Results First Posted : February 15, 2013
Last Update Posted : December 12, 2016
University of Rostock
Information provided by (Responsible Party):
Max Dieterich, University of Rostock

Brief 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.

Condition or disease Intervention/treatment Phase
Pain Drug: Oral Oxycodon Drug: Piritramid Phase 4

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  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial: Pain Management After Cesarean Section: Oxycodon vs. Intravenous Piritramide
Study Start Date : July 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

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.

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. Subgroups [ Time Frame: 6 month ]
    Secondary Outcome Measures were to identify subgroups in benefit of either therapy.

  2. Side Effects [ Time Frame: 6 month ]
    Evaluation of side effects

  3. Mobilisation [ Time Frame: 6 month ]
    Evaluation of time to post surgical mobilization

  4. Costs [ Time Frame: 6 month ]
    Evaluation costs between groups

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01115101

University of Rostock, Department of Obstetrics and Gynecology
Rostock, MV, Germany, 18055
Sponsors and Collaborators
Max Dieterich
University of Rostock
Principal Investigator: Max Dieterich, MD University of Rostock, Department of Obstetrics and Gynecology

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Max Dieterich, Dr. Max Dieterich, University of Rostock Identifier: NCT01115101     History of Changes
Other Study ID Numbers: KJ-2009-MD
First Posted: May 4, 2010    Key Record Dates
Results First Posted: February 15, 2013
Last Update Posted: December 12, 2016
Last Verified: October 2016

Keywords provided by Max Dieterich, University of Rostock:
pain after cesarean
visual analog scale

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents