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Completed

NCT Number: NCT01115101

Superiority Study for Pain Treatment After Cesarean

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Rostock, Department of Obstetrics and Gynecology

Rostock, Mecklenburg-Vorpommern, 18055, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Oxycodon

Drug

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

Piritramid

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Max Dieterich

Other

Collaborators

  • University of Rostock

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 4, 2010
Registry last updated
Dec 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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