Single Shot Fascia Iliaca Block vs Femoral Nerve Block for Analgesia for Surgical Fixation of Hip Fractures

January 23, 2018 updated by: Changi General Hospital

A Randomized Controlled Trial Comparing Single Shot Fascia Iliaca Block With Femoral Nerve Block for Analgesia Following Surgical Fixation of Hip Fractures

Hip fractures are common in our elderly population and is associated with pain before and after surgery. The current pain management for patients who have undergone surgery for hip fractures include a combination of oral painkillers, opioids (eg morphine) and regional anaesthesia techniques, which involves the injection of local anaesthetic drugs near nerves supplying the hip joint to numb the operation site. As opioids have many side effects, especially in the elderly patients, regional anaesthesia techniques can help to reduce the use of opioids and the related side effects. This may enhance their recovery and length of hospital stay

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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

  • Singapore
      • Singapore, Singapore, 529889
        • Changi 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients scheduled for surgical fixation of hip fracture
  • Patients with isolated inter-trochantric fracture
  • American Society of Anesthesiologists (ASA) physical status 1 to 3
  • Patients who are able to give their own consent

Exclusion Criteria:

  • Patients unable to give consent or inability to communicate/ cooperate
  • Patients with regular consumption of strong opioids (morphine, oxycodone) or steroids
  • Patients with allergy to local anaesthetics or any drugs included in the study
  • Patients with contraindications to spinal anaesthesia such as coagulation disorders/ thrombocytopenia and local infection at site of injection

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Femoral nerve block
Procedure: Ultrasound-guided femoral nerve block Drug: Ropivacaine 0.5% 30mls
Drug: Ropivacaine
Ultrasound-guided femoral nerve block with Ropivacaine 0.5% 30mls
Other Names:
  • naropin
Drug: Ropivacaine
Ultrasound-guided suprainguinal approach to fascia iliaca block with Ropivacaine 0.5% 30mls
Other Names:
  • naropin
Active Comparator: Fascia Iliaca block
Procedure: Ultrasound-guided suprainguinal approach to fascia iliaca block Drug: Ropivacaine 0.5% 30mls
Drug: Ropivacaine
Ultrasound-guided femoral nerve block with Ropivacaine 0.5% 30mls
Other Names:
  • naropin
Drug: Ropivacaine
Ultrasound-guided suprainguinal approach to fascia iliaca block with Ropivacaine 0.5% 30mls
Other Names:
  • naropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores
Time Frame: up to 24 hours
resting and dynamic pain scores are obtained pre-intervention, 30mins post intervention (and on positioning for spinal anaesthesia), 1 hr post-operatively and at 24hrs post intervention
up to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
opioid requirement/consumption
Time Frame: for first 24 hrs (including intra operatively) following intervention
need for additional opioids during first 24hrs following intervention record of any opioid related side effects will be kept as well
for first 24 hrs (including intra operatively) following intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications associated with intervention
Time Frame: at 24 hrs post intervention
including hematoma, infection, prolonged neurologic deficits, occurence of falls
at 24 hrs post intervention

Collaborators and Investigators

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

Sponsor

Changi General Hospital

Investigators

  • Principal Investigator: Yean Chin Lim, MBBS, MMed, Changi General Hospital

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

August 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

December 31, 2014

First Submitted That Met QC Criteria

December 31, 2014

First Posted (Estimate)

January 1, 2015

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/453/D

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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