NCT00815503

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 30, 2008

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 16, 2011

Status Verified

March 1, 2011

Enrollment Period

1.9 years

First QC Date

December 29, 2008

Last Update Submit

March 15, 2011

Conditions

Periacetabular OsteotomyPain

Keywords

AnestheticsLocal infiltrationPeriacetabular osteotomy

Outcome Measures

Primary Outcomes (1)

  • Consumption of rescue analgetics

    Assesment of opioid rescue analgetics every 24 hours for 14 days postoperatively

Secondary Outcomes (1)

  • Pain

    Assessment of pain four times every day for five days postoperatively

Study Arms (2)

Ropivacaine

ACTIVE COMPARATOR
Drug: Ropivacaine

Saline

PLACEBO COMPARATOR
Drug: Placebo

Interventions

RopivacaineDRUG

Approved by the Danish Medicines Agency

Ropivacaine
PlaceboDRUG

Saline

Saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Intolerance of local anaesthesia
  • Habitual use of opioids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 24650022DERIVED

MeSH Terms

Conditions

Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 29, 2008

First Posted

December 30, 2008

Study Start

January 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

March 16, 2011

Record last verified: 2011-03

Locations

DK(1)