Superiority Study for Pain Treatment After Cesarean

Study Overview
=================
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.

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.

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

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Oral Oxycodon
* Drug: Piritramid


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxycodon<br> | Drug: Oral Oxycodon<br>* Patients assigned to the oral analgesia group received 20mg oxycodon at fixed intervals: 2 hours (h) and between 12h and 14h after cesarean.<br>|
| Active Comparator: Patient controlled analgesia (PCA) device with Pritramid<br> | Drug: Piritramid<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Pain level was evaluated before therapy (2h after CS), 12h, 24h, 32h, 40h, 48 and 72h after CS. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subgroups | Secondary Outcome Measures were to identify subgroups in benefit of either therapy. | 6 month | 
| Side Effects | Evaluation of side effects | 6 month | 
| Mobilisation | Evaluation of time to post surgical mobilization | 6 month | 
| Costs | Evaluation costs between groups | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain after cesarean, visual analog scale, oxycodon, piritramid