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

December 29, 2008
March 15, 2011
January 2009
December 2010   (final data collection date for primary outcome measure)
Consumption of rescue analgetics [ Time Frame: Assesment of opioid rescue analgetics every 24 hours for 14 days postoperatively ] [ Designated as safety issue: No ]
Consumption of rescue analgetics
Complete list of historical versions of study NCT00815503 on ClinicalTrials.gov Archive Site
Pain [ Time Frame: Assessment of pain four times every day for five days postoperatively ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Postoperative Analgesia With Local Infiltration After Periacetabular Osteotomy
Postoperative Analgesia With Local Infiltration After Periacetabular Osteotomy For The Treatment Of Dysplasia

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Periacetabular Osteotomy
  • Pain
  • Drug: Ropivacaine
    Approved by the Danish Medicines Agency
  • Drug: Placebo
    Saline
  • Active Comparator: Ropivacaine
    Intervention: Drug: Ropivacaine
  • Placebo Comparator: Saline
    Intervention: Drug: Placebo
Bech RD, Ovesen O, Lindholm P, Overgaard S. Local anesthetic wound infiltration for pain management after periacetabular osteotomy. A randomized, placebo-controlled, double-blind clinical trial with 53 patients. Acta Orthop. 2014 Apr;85(2):141-6. doi: 10.3109/17453674.2014.899840.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Intolerance of local anaesthesia
  • Habitual use of opioids
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00815503
S20080152
Yes
Rune Bech, Odense University Hospital
Odense University Hospital
Not Provided
Not Provided
Odense University Hospital
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP