Superiority Study for Pain Treatment After Cesarean

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Oral Oxycodon; Drug: Piritramid

• Registration Number: NCT01115101
• Lead Sponsor: Max Dieterich

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.

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Study First Submitted: 2010-04-27
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-04
• Results First Submitted: 2012-02-21
• Results First Submitted QC: 2013-01-15
• Results First Posted: 2013-02-15
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-28
• Last Update Posted: 2016-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 239

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxycodon	Oral Oxycodon	-
Patient controlled analgesia (PCA) device with Pritramid	Piritramid	-

Primary Outcome Measures

Name	Time	Method
Difference of Pain Scores on the Visual Analog Scale	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 Outcome Measures

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

Trial Locations

Locations (1)

University of Rostock, Department of Obstetrics and Gynecology; 🇩🇪 Rostock, MV, Germany