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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
239
Patients assigned to the oral analgesia group received 20mg oxycodon at fixed intervals: 2 hours (h) and between 12h and 14h after cesarean.
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.
University of Rostock, Department of Obstetrics and Gynecology
Rostock, Mecklenburg-Vorpommern, Germany
Difference of Pain Scores on the Visual Analog Scale
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).
Time frame: Pain level was evaluated before therapy (2h after CS), 12h, 24h, 32h, 40h, 48 and 72h after CS.
Subgroups
Secondary Outcome Measures were to identify subgroups in benefit of either therapy.
Time frame: 6 month
Side Effects
Evaluation of side effects
Time frame: 6 month
Mobilisation
Evaluation of time to post surgical mobilization
Time frame: 6 month
Costs
Evaluation costs between groups
Time frame: 6 month
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