Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
239 participants
INTERVENTIONAL
2009-07-31
2009-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Oxycodon
Oral Oxycodon
Patients assigned to the oral analgesia group received 20mg oxycodon at fixed intervals: 2 hours (h) and between 12h and 14h after cesarean.
Patient controlled analgesia (PCA) device with Pritramid
Piritramid
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Oral Oxycodon
Patients assigned to the oral analgesia group received 20mg oxycodon at fixed intervals: 2 hours (h) and between 12h and 14h after cesarean.
Piritramid
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* no history of opioid or metamizol treatment
* written consent
* ability to use a Patient-controlled analgesia device
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Rostock
OTHER
Max Dieterich
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Max Dieterich
Dr. Max Dieterich
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Max Dieterich, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rostock, Department of Obstetrics and Gynecology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Rostock, Department of Obstetrics and Gynecology
Rostock, Mecklenburg-Vorpommern, Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KJ-2009-MD
Identifier Type: -
Identifier Source: org_study_id