Superiority Study for Pain Treatment After Cesarean

Pain Clinical Trial

Official title:

A Randomized Controlled Trial: Pain Management After Cesarean Section: Oxycodon vs. Intravenous Piritramide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115101
• Other study ID #: KJ-2009-MD
• Status: Completed
• Phase: Phase 4
• First received: April 27, 2010
• Last updated: January 15, 2013
• Start date: July 2009
• Est. completion date: November 2009

Study information

• Verified date: January 2013
• Source: University of Rostock
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Germany	University of Rostock, Department of Obstetrics and Gynecology	Rostock	MV

Sponsors (2)

Lead Sponsor	Collaborator
Max Dieterich	University of Rostock

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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):1182-7, table of contents. — View 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. — View 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. — View Citation

Stamer UM, Wiese R, Stüber F, Wulf H, Meuser T. Change in anaesthetic practice for Caesarean section in Germany. Acta Anaesthesiol Scand. 2005 Feb;49(2):170-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of Pain Scores on the Visual Analog Scale	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.	Pain level was evaluated before therapy (2h after CS), 12h, 24h, 32h, 40h, 48 and 72h after CS.	No
Secondary	Subgroups	Secondary Outcome Measures were to identify subgroups in benefit of either therapy.	6 month	No
Secondary	Side Effects	Evaluation of side effects	6 month	No
Secondary	Mobilisation	Evaluation of time to post surgical mobilization	6 month	No
Secondary	Costs	Evaluation costs between groups	6 month	No