Fascia Iliaca Compartment Block in Acute and Chronic Pain Management in Hip Fracture Patients

NCT ID: NCT02479828

Last Updated: 2019-03-12

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

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2018-01-31

Brief Summary

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This study evaluates the effect of fascia iliaca compartment block (FICB) in the management of acute post -surgical pain in hip fracture patients and in the appearance of chronic post -surgical hip pain, by means of von Korff Graded Chronic Pain Scale -modified for hip pain in Greek.

Half of the patients will not receive fascia iliaca compartment block.

Detailed Description

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Conditions

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Chronic Hip Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Fascia iliaca compartment block (FICB)

Under ultrasound guidance performing fascia iliaca compartment block, in which 40 ml ropivacaine 0,5% are injected under the fascia iliaca.

Group Type ACTIVE_COMPARATOR

Fascia iliaca compartment block

Intervention Type DRUG

40 ml ropivacaine 0,5% injected under fascia iliaca using ultrasound

Ropivacaine

Intervention Type DRUG

ultrasound

Intervention Type DEVICE

Placebo (not FICB)

Half of the patients will not receive FICB

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Fascia iliaca compartment block

40 ml ropivacaine 0,5% injected under fascia iliaca using ultrasound

Intervention Type DRUG

Ropivacaine

Intervention Type DRUG

ultrasound

Intervention Type DEVICE

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA I-III (American Society of Anesthesiologists classification)
* intertrochanteric fractures
* fractures of femoral neck

Exclusion Criteria

* existing pain in hip Joint to be operated
* cognitive or mental disorder
* administration of analgesic drugs prior surgery
* contraindications of spinal anesthesia
* refusal to participate in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asklepieion Voulas General Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Maria Diakomi

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MARIA DIAKOMI

Role: PRINCIPAL_INVESTIGATOR

Asklepieion General Hospital

Locations

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Asklepieion General Hospital

Athens, Voula, Greece

Site Status

Countries

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Greece

References

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Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.

Reference Type DERIVED
PMID: 33238043 (View on PubMed)

Other Identifiers

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7533

Identifier Type: -

Identifier Source: org_study_id

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