Superiority Study for Pain Treatment After Cesarean
|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|
- 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.
- 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
|Study Start Date:||July 2009|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
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||
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01115101
|University of Rostock, Department of Obstetrics and Gynecology|
|Rostock, MV, Germany, 18055|
|Principal Investigator:||Max Dieterich, MD||University of Rostock, Department of Obstetrics and Gynecology|