Postoperative Analgesia With Local Infiltration After Femoral Neck Fracture

NCT ID: NCT00529425

Last Updated: 2010-05-06

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-12-31

Brief Summary

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Reducing pain is an essential factor for early mobilization after osteosynthesis of femoral neck fractures. Systemic opioids have side effects that might obstruct mobilization and induce delirium and nausea. The investigators hypothesized that wound infiltration results in reduction in systemic opioid usage and pain relief without side effects.

Detailed Description

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Conditions

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Femoral Neck Fracture

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

Saline

Group Type PLACEBO_COMPARATOR

Ropivacaine

Intervention Type DRUG

Interventions

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Ropivacaine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Femoral neck fracture
* Fracture due to low energy trauma
* Ability to understand danish and give informed consent
* Ability to walk before trauma
* Indication for osteosynthesis
* ≥ 8 in OMC (Orientation-Memory-Concentration) test with a possible maximum of 28 points
* Informed consent

Exclusion Criteria

* Drug or medical abuse
* Drug intolerance
* Pathological fractures
* Inflammatory arthritis
* Patient included in the study with the contralateral hip
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Soren Overgaard, Professor, MD, DmSc

Role: STUDY_CHAIR

Odense University Hospital, DK-5000 Odense C, Denmark

Rune Dueholm Bech, MD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital, DK-5000 Odense C, Denmark

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, Lauritsen J, Ovesen O, Emmeluth C, Lindholm P, Overgaard S. Local anaesthetic wound infiltration after internal fixation of femoral neck fractures: a randomized, double-blind clinical trial in 33 patients. Hip Int. 2011 Mar-Apr;21(2):251-9. doi: 10.5301/HIP.2011.6513. Epub 2011 Apr 5.

Reference Type DERIVED
PMID: 21484739 (View on PubMed)

Other Identifiers

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S-VF-20060072 - femoral neck

Identifier Type: -

Identifier Source: org_study_id

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