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Postoperative Analgesia With Local Infiltration After Periacetabular Osteotomy

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ClinicalTrials.gov Identifier: NCT00815503
Recruitment Status : Completed
First Posted : December 30, 2008
Last Update Posted : March 16, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
Pain treatment after periacetabular osteotomy is traditionally based on systemic opioids wich have side effects. The purpose of this study is to evaluate the analgetic effect of wound infiltration with local anaesthesia after periacetabular osteotomy.

Condition or disease Intervention/treatment Phase
Periacetabular Osteotomy Pain Drug: Ropivacaine Drug: Placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Analgesia With Local Infiltration After Periacetabular Osteotomy For The Treatment Of Dysplasia
Study Start Date : January 2009
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Ropivacaine Drug: Ropivacaine
Approved by the Danish Medicines Agency
Placebo Comparator: Saline Drug: Placebo
Saline


Outcome Measures

Primary Outcome Measures :
  1. Consumption of rescue analgetics [ Time Frame: Assesment of opioid rescue analgetics every 24 hours for 14 days postoperatively ]

Secondary Outcome Measures :
  1. Pain [ Time Frame: Assessment of pain four times every day for five days postoperatively ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Periacetabular osteotomy due to traditional dysplasia or retroverted acetabulum
  • Informed consent

Exclusion Criteria:

  • Intolerance of local anaesthesia
  • Habitual use of opioids
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00815503


Locations
Denmark
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rune Bech, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00815503     History of Changes
Other Study ID Numbers: S20080152
First Posted: December 30, 2008    Key Record Dates
Last Update Posted: March 16, 2011
Last Verified: March 2011

Keywords provided by Odense University Hospital:
Anesthetics
Local infiltration
Periacetabular osteotomy

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents