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Postoperative Analgesia With Local Infiltration After Periacetabular Osteotomy

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00815503
First received: December 29, 2008
Last updated: March 15, 2011
Last verified: March 2011
History of Changes
  Purpose

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 Intervention Phase
Periacetabular Osteotomy
Pain
 Drug: Ropivacaine
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Analgesia With Local Infiltration After Periacetabular Osteotomy For The Treatment Of Dysplasia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Consumption of rescue analgetics [ Time Frame: Assesment of opioid rescue analgetics every 24 hours for 14 days postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain [ Time Frame: Assessment of pain four times every day for five days postoperatively ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: January 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ropivacaine Drug: Ropivacaine
Approved by the Danish Medicines Agency
Placebo Comparator: Saline Drug: Placebo
Saline

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00815503

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

No publications provided

Responsible Party: Rune Bech, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00815503     History of Changes
Other Study ID Numbers: S20080152
Study First Received: December 29, 2008
Last Updated: March 15, 2011
Health Authority: Denmark: Danish Medicines Agency
Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: GCP Unit, Odense University Hospital
Denmark: Danish Dataprotection Agency

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
 Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013