A Randomized Controlled Trial: Pain Management After Cesarean Section: Oxycodon vs. Intravenous Piritramide
Overview
- Phase
- Phase 4
- Intervention
- Oral Oxycodon
- Conditions
- Pain
- Sponsor
- Max Dieterich
- Enrollment
- 239
- Locations
- 1
- Primary Endpoint
- Difference of Pain Scores on the Visual Analog Scale
- Status
- Completed
- Last Updated
- 9 years ago
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.
Investigators
Max Dieterich
Dr. Max Dieterich
University of Rostock
Eligibility Criteria
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
Arms & Interventions
Oxycodon
Intervention: Oral Oxycodon
Patient controlled analgesia (PCA) device with Pritramid
Intervention: Piritramid
Outcomes
Primary Outcomes
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
- Mobilisation(6 month)
- Subgroups(6 month)
- Side Effects(6 month)
- Costs(6 month)