Is Regional Anesthesia of the Hip Preferable Over Traditional Analgesia in the Acute Stage of the Management of Patients With a Fracture of the Hip

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-04-30

Brief Summary

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The main hypothesis of the study is that anaesthesia of the hip using infiltration with a local anesthetic solution is preferable over traditional analgesia with oral opioid medications in the acute stage of the management of patients with a fracture of the hip.

To study the hypothesis the investigators designed a prospective randomised study where patients are assigned in two groups, the first receiving local hip anesthesia and the other placebo treatment. Both groups are eligible to use of standard oral pain treatment.

Effect of analgesia as well as medical complications will be recorded.

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Detailed Description

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Conditions

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Hip Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ropivacaine

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

Local injection (fascia iliaca block) using 150 mg ropivacaine

Natrium chloride

Group Type PLACEBO_COMPARATOR

Natrium chloride

Intervention Type DRUG

Placebo injection of Natrium chloride solution

Interventions

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Ropivacaine

Local injection (fascia iliaca block) using 150 mg ropivacaine

Intervention Type DRUG

Natrium chloride

Placebo injection of Natrium chloride solution

Intervention Type DRUG

Other Intervention Names

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Narop

Eligibility Criteria

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Inclusion Criteria

* fracture of the hip

Exclusion Criteria

* multiple fractures,
* delay (more than 12 hours) from the time of injury until admission to the hospital,
* local infections, hypersensitivity to local analgetics,
* cognitive impairment

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No