Clinical trial NCT01115101: Superiority Study for Pain Treatment After Cesarean
Official title: A Randomized Controlled Trial: Pain Management After Cesarean Section: Oxycodon vs. Intravenous Piritramide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: pain after cesarean
visual analog scale
oxycodon
piritramid
Lead sponsor: University of Rostock
Sponsor class: OTHER
Collaborators: name: University of Rostock
First posted: 2010-05-04
Enrollment: 239
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Difference of Pain Scores on the Visual Analog Scale
timeFrame: Pain level was evaluated before therapy (2h after CS), 12h, 24h, 32h, 40h, 48 and 72h after CS.
Secondary outcomes:
measure: Subgroups
timeFrame: 6 month
measure: Side Effects
timeFrame: 6 month
measure: Mobilisation
timeFrame: 6 month
measure: Costs
timeFrame: 6 month
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: University of Rostock, Department of Obstetrics and Gynecology
state: MV
Study officials:
affiliation: University of Rostock, Department of Obstetrics and Gynecology
name: Max Dieterich, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stamer UM, Wiese R, Stuber F, Wulf H, Meuser T. Change in anaesthetic practice for Caesarean section in Germany. Acta Anaesthesiol Scand. 2005 Feb;49(2):170-6. doi: 10.1111/j.1399-6576.2004.00583.x.
citation: Davis KM, Esposito MA, Meyer BA. Oral analgesia compared with intravenous patient-controlled analgesia for pain after cesarean delivery: a randomized controlled trial. Am J Obstet Gynecol. 2006 Apr;194(4):967-71. doi: 10.1016/j.ajog.2006.02.025.
citation: Gammaitoni AR, Galer BS, Bulloch S, Lacouture P, Caruso F, Ma T, Schlagheck T. Randomized, double-blind, placebo-controlled comparison of the analgesic efficacy of oxycodone 10 mg/acetaminophen 325 mg versus controlled-release oxycodone 20 mg in postsurgical pain. J Clin Pharmacol. 2003 Mar;43(3):296-304. doi: 10.1177/0091270003251147.
citation: Carvalho B, Cohen SE, Lipman SS, Fuller A, Mathusamy AD, Macario A. Patient preferences for anesthesia outcomes associated with cesarean delivery. Anesth Analg. 2005 Oct;101(4):1182-1187. doi: 10.1213/01.ane.0000167774.36833.99.
citation: Dieterich M, Muller-Jordan K, Stubert J, Kundt G, Wagner K, Gerber B. Pain management after cesarean: a randomized controlled trial of oxycodone versus intravenous piritramide. Arch Gynecol Obstet. 2012 Oct;286(4):859-65. doi: 10.1007/s00404-012-2384-5. Epub 2012 May 24.