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NCT00815503 Clinical Trial

Postoperative Analgesia With Local Infiltration After Periacetabular Osteotomy

Pain Clinical Trial

Official title:
Postoperative Analgesia With Local Infiltration After Periacetabular Osteotomy For The Treatment Of Dysplasia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00815503
Other study ID # S20080152
Secondary ID
Status Completed
Phase Phase 4
First received December 29, 2008
Last updated March 15, 2011
Start date January 2009
Est. completion date December 2010

Study information
Verified date March 2011
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines AgencyDenmark: The Regional Committee on Biomedical Research EthicsDenmark: GCP Unit, Odense University HospitalDenmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Periacetabular osteotomy due to traditional dysplasia or retroverted acetabulum

- Informed consent

Exclusion Criteria:

- Intolerance of local anaesthesia

- Habitual use of opioids

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ropivacaine
Approved by the Danish Medicines Agency
• Placebo
Saline

Locations
Country Name City State
Denmark Odense University Hospital Odense

Sponsors (1)
Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Consumption of rescue analgetics Assesment of opioid rescue analgetics every 24 hours for 14 days postoperatively No
Secondary Pain Assessment of pain four times every day for five days postoperatively No
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