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Superiority Study for Pain Treatment After Cesarean

This study has been completed.
Sponsor:
Collaborator:
University of Rostock
Information provided by (Responsible Party):
Max Dieterich, University of Rostock
ClinicalTrials.gov Identifier:
NCT01115101
First received: April 27, 2010
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Pain
 Drug: Oral Oxycodon
Drug: Piritramid
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial: Pain Management After Cesarean Section: Oxycodon vs. Intravenous Piritramide

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Further study details as provided by University of Rostock:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Subgroups [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Secondary Outcome Measures were to identify subgroups in benefit of either therapy.

  • Side Effects [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Evaluation of side effects

  • Mobilisation [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Evaluation of time to post surgical mobilization

  • Costs [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Evaluation costs between groups


Enrollment: 239
Study Start Date: July 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01115101

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Max Dieterich, Dr. Max Dieterich, University of Rostock
ClinicalTrials.gov Identifier: NCT01115101     History of Changes
Other Study ID Numbers: KJ-2009-MD
Study First Received: April 27, 2010
Results First Received: February 21, 2012
Last Updated: January 15, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Rostock:
pain after cesarean
visual analog scale
oxycodon
piritramid

Additional relevant MeSH terms:
Pirinitramide
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on June 18, 2013