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

March 11, 2019 updated by: Maria Diakomi, Asklepieion Voulas General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Voula
      • Athens, Voula, Greece, 16673
        • Asklepieion General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: ultrasound
Drug: Ropivacaine
Drug: Fascia iliaca compartment block
40 ml ropivacaine 0,5% injected under fascia iliaca using ultrasound
Placebo Comparator: Placebo (not FICB)
Half of the patients will not receive FICB
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute postsurgical pain after hip fracture surgery
Time Frame: 48 hours
Acute pain will be evaluated using the Numeric Rating Scale- NRS (0=no pain, 10= Extremely strong pain) at rest and in motion.
48 hours
Chronic postsurgical pain after hip fracture surgery
Time Frame: 6 months
3 and 6 months after surgery the patient or patient's relative will be asked on telephone to complete Von Korff Graded Chronic scale modified for hip pain
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asklepieion Voulas General Hospital

Investigators

  • Principal Investigator: MARIA DIAKOMI, Asklepieion General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

June 10, 2015

First Submitted That Met QC Criteria

June 23, 2015

First Posted (Estimate)

June 24, 2015

Study Record Updates

Last Update Posted (Actual)

March 12, 2019

Last Update Submitted That Met QC Criteria

March 11, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7533 (Other Identifier: CTEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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