Superiority Study for Pain Treatment After Cesarean

NCT01115101 | Completed Phase 4 Results

• 1 other identifier: KJ-2009-MD
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

pain after cesarean; visual analog scale; oxycodon; piritramid

Outcome Measures

Primary Outcomes (1)

• 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. Single value were calculated (averaged).

  Pain level was evaluated before therapy (2h after CS), 12h, 24h, 32h, 40h, 48 and 72h after CS.

Secondary Outcomes (4)

• Subgroups

  6 month

• Side Effects

  6 month

• Mobilisation

  6 month

• Costs

  6 month

Study Arms (2)

Oxycodon

EXPERIMENTAL

Drug: Oral Oxycodon

Patient controlled analgesia (PCA) device with Pritramid

ACTIVE COMPARATOR

Drug: Piritramid

Interventions

Oral Oxycodon DRUG

Patients assigned to the oral analgesia group received 20mg oxycodon at fixed intervals: 2 hours (h) and between 12h and 14h after cesarean.

Oxycodon

Piritramid DRUG

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.

Patient controlled analgesia (PCA) device with Pritramid

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cesarean in spinal anesthesia,
• no history of opioid or metamizol treatment
• written consent
• ability to use a Patient-controlled analgesia device

You may not qualify if:

• 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

Sponsors & Collaborators

• Max Dieterich: lead
• University of Rostock: collaborator

Study Sites (1)

University of Rostock, Department of Obstetrics and Gynecology

Rostock, Mecklenburg-Vorpommern, 18055, Germany

Location

Related Publications (5)

• 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.

  PMID: 15715617 BACKGROUND

• 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.

  PMID: 16580284 BACKGROUND

• 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.

  PMID: 12638399 BACKGROUND

• 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.

  PMID: 16192541 BACKGROUND

• 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.

  PMID: 22622852 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Pirinitramide

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Isonipecotic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Max Dieterich
• Organization: University of Rostock

max.dieterich@uni-rostock.de

+493814401

Study Officials

• Max Dieterich, MD

  University of Rostock, Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Max Dieterich

Study Record Dates

• First Submitted: April 27, 2010
• First Posted: May 4, 2010
• Study Start: July 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: December 12, 2016
• Results First Posted: February 15, 2013

Record last verified: 2016-10

Locations

DE (1)