Superiority Study for Pain Treatment After Cesarean

Max Dieterich

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Piritramid; Drug: Oral Oxycodon

Study type: Interventional

Funder types: Other

Identifiers

NCT01115101

KJ-2009-MD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 239 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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239 participants in 2 patient groups

Oxycodon

Experimental group

Treatment:

Drug: Oral Oxycodon

Patient controlled analgesia (PCA) device with Pritramid

Active Comparator group

Treatment:

Drug: Piritramid