Postoperative Analgesia With Local Infiltration After Periacetabular Osteotomy

NCT ID: NCT00815503

Last Updated: 2011-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Periacetabular Osteotomy Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ropivacaine

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

Approved by the Danish Medicines Agency

Saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline

Interventions

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Ropivacaine

Approved by the Danish Medicines Agency

Intervention Type DRUG

Placebo

Saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Intolerance of local anaesthesia
* Habitual use of opioids
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Odense University Hospital

Locations

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Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 24650022 (View on PubMed)

Other Identifiers

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S20080152

Identifier Type: -

Identifier Source: org_study_id

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