Comparison Between Ultrasound Guided Femoral 3 in 1 Block Versus Blind Fascia Iliaca Block Before Spinal Anaesthesia (IKH)

May 3, 2017 updated by: Rhendra Hardy Mohamad Zaini, Universiti Sains Malaysia

Comparison the Efficacy as Analgesia Between Ultrasound Guided Femoral 3 in 1 Block Versus Blind Fascia Iliaca Block for Positioning Prior Spinal Anaesthesia in Femur Fracture Surgery

This study aimed to evaluate the efficacy of ultrasound guided femoral 3 in 1 block versus the blind technique single shot fascia iliaca compartment block as an analgesia method in patients prior positioning for spinal anaesthesia in femur fracture surgery. A total of 60 patients were enrolled and divided equally into 2 groups.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is to evaluate the efficacy of fascia iliaca compartment block comparing to femoral nerve block. If it is proven effective, this technique should be implemented as a method of analgesia (pain relief) prior positioning for spinal anaesthesia. As fascia iliaca compartment block is relatively easy to be done without the need of advanced equipment, it has the potential role for good pain management in patient with femur fracture. Thus this will reduce the need of intravenous or oral analgesic such as opioid or nonsteroidal anti-inflammatory drugs and side effects that comes with it.

This is a prospective single blind randomized study of a total of 60 patients ASA I - III who were scheduled to undergo fixation of femur fractures. Patients who fulfilled the criteria were recruited after informed consent was taken. This study was conducted in the operation theatres of the Hospital Universiti Sains Malaysia, Kubang Kerian, Kelantan.

Hypothesis

  1. There is no difference in term of success rate between ultrasound guided Femoral 3 in 1 nerve block versus Single shot blind Fascia Iliaca Compartment Block prior positioning for spinal anaesthesia in femur fracture surgery.
  2. There is no difference in term of analgesic effect between ultrasound guided Femoral 3 in 1 nerve block versus Single shot blind Fascia Iliaca Compartment Block prior positioning for spinal anaesthesia in femur fracture surgery.
  3. There is no different in term of onset of analgesia between Femoral 3 in 1 nerve block versus Fascia Iliaca Compartment Block prior positioning for spinal anaesthesia in femur fracture surgery.

Recruitment and Randomization Eligible patients will be approach and offered to participate in this study prior operation. Agreed patients will have to sign informed consent Subject will be randomized into 2 groups using computer assisted randomization

Sample Size Calculation The sample size was calculated based on reduction of visual analog score in a study done by Newman et al with score 3.7±2.6, α = 0.05 and power of study 80%. The patients were randomized per a computerized generated random number and divided into two groups. Group A (FICB) n = 30, received single shot fascia iliaca compartment block (blind technique) and the other group B (FNB) n = 30 received ultrasound guided femoral 3 in 1 block. Initial target sample of 66 was calculated including drop out, however as there was no drop out from the study we decided to stop at 60 samples only. As 30 samples for each arm was adequate for a clinical study to be conducted and data acquired can be statistically analysed.

Study Protocol After ethic approval, written informed consent will be obtained from participants that met inclusion/exclusion criteria.

A total of 66 adults who are planned for open reduction internal fixation (ORIF) of proximal femur fracture will be enrolled. Easy sample random sampling using opaque and sealed envelope will be used to divide patient into Group 1 (Group Femoral 3 in 1 Block) and Group 2 (Fascia Iliaca Compartment Block) with ratio 1:1.

Random sampling will be done upon patient arrival to reception area in operation theatre complex. Both block will be performed by principal investigator in induction anaesthetic room while waiting for surgery. Data will be collected by registered nurse anaesthetist monitoring preoperatively and resident anaesthetist who's in charge in the operating theatre.

Block will be performed in induction room near the recovery area in operating theatre (OT) complex. Basic and standardized monitoring as listed by American Society of Anaesthesiologist (ASA) will be applied such as Non-invasive blood pressure monitoring (NIBP), Heart rate (HR), Oxygen saturation (SpO2) and electrocardiogram (ECG). Patient will be monitored continuously during the procedure. Apart from that, a variable performance oxygen delivery system will be given using nasal cannula at 3 litre/min. At least 1 functioning cannula will be made available with running IV drip. Preparation for emergency airway intervention and resuscitation drug will also be prepared before performing intended block.

In both group, block will be performed with patient in supine position, under aseptic technique using chlorhexidine solution and drape with sterile medical towel. Both group will be given Lignocaine 2% for local infiltration at puncture site. Ropivacaine 0.375% will be used in both groups with a total volume depends on weight basis.

Group 1 (Femoral 3 in 1 Block/FNB) This group will be given femoral 3 in 1 block Needle: Stimuplex or Locoplex 22-gauge 50-mm insulated needle Using Ultrasound guidance and peripheral nerve stimulator. Total Volume of Local anaesthetic: 20-40mls. Ultrasound will be use to locate the femoral vessel and nerve. Using 'in plane' technique, the needle will be puncture and advance in transverse plane at a 30 angle to the skin. Peripheral Nerve stimulator will be used if there is difficulty in recognizing the nerve, stimulation of the nerve will cause contraction of quadriceps femoris muscle. A total 20-40mls of local anaesthetic solution as per ideal body weight will be injected over a 2-3minutes duration after careful negative aspiration of blood to rule out inadvertent intravascular puncture. Careful aspiration will be done in every 3-5mls injection until a total of 20-40mls local anaesthetic being delivered.

Group 2: Fascia Iliaca Compartment Block (FICB) This group will be given fascia iliaca compartment block as shown in figure 3. Needle: Luer Lock cannula (Plexufix) 24-gauge 50-mm insulated needle Total Volume of Local anaesthetic: 20-40mls based on ideal body weight The technique is done as described by Dalens et al, 1989 using anatomical landmark technique. A line is drawn from pubic tubercle to anterior superior iliac spine (ASIS) and divided into 3 equal parts. The puncture point is 2-3cm distal to the point where medial 2/3rd and lateral 1/3rd of the line meet. The femoral vessel will be identified and should lie medial to the puncture site. The fascia iliaca block will be perform without using the nerve stimulator or ultrasound.

By using a blunted needle (24G, plexufix needle), identification of puncturing intended space is by feeling 2 times loss of resistance (described as clicks or plops). This indicates the puncture of fascia lata and fascia iliaca. After careful aspiration with syringe to rule out inadvertent vascular injection, a total volume of local anaesthetic (LA) will be given according to group allocation and body weight. Bolus of LA given in 2-3minutes duration with repeated aspiration. In case of accidental vascular puncture, needle is withdrawn and punctured site will be compressed for 5 minutes to avoid haematoma before reattempt lateral 1-2cm from initial site.

For both group, any signs of complication will be look for, documented and treated accordingly. Examples are:

  1. Local anaesthetic toxicity such tingling sensation around mouth, metallic taste, light headache, confusion, altered conscious level, seizures, visual disturbances, arrhythmias and cardiovascular collapse
  2. Swelling at site of puncture due to hematoma or localization of local anaesthetic
  3. Bleeding from puncture site

Precaution to avoid complication from procedure:

  1. Dose local anaesthetic should be precalculated to avoid toxicity, total maximum dose of Ropivacaine is 3mg/kg
  2. Careful negative aspiration before giving intended local anaesthetic in titrating dose to avoid inadvertent vascular puncture
  3. Total volume of local anaesthetic given in repeated aspiration and in titrating dose in 2-3 minutes' duration

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Malaysia
    • Kelantan
      • Kubang Kerian, Kelantan, Malaysia, 16150
        • University of Science Malaysia 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I - III with stable hemodynamic parameters
  • Planned for open reduction internal fixation of fracture femur under spinal anaesthesia

Exclusion Criteria:

  • Coagulopathy/ Bleeding diathesis
  • Known allergy to amide local anaesthetic used 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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Fascia Iliaca Compartment Block (FICB)
fascia iliaca compartment block is done using a blind technique with a blunt size 24 Gauge (G) needle. The technique is based upon the anatomical landmark and once located the space local anaesthetic ropivacaine 0.375% will be given based on the body weight.
Procedure: Fascia Iliaca Compartment Block (FICB)
The FICB was done in the OT with standard monitoring with emergency airway intervention and resuscitation drug prepared before performing intended block. Patient was put in supine position, using aseptic technique, chlorhexidine solution and draped with sterile medical towel. Lignocaine 2% for local anaesthetic infiltration at punctured site.A blunted needle (Plexufix® 24G x 2", B Braun Melsungen AG 34209 Germany).A line was drawn from pubic tubercle to anterior superior iliac spine, the punctured point is 2-3cm distal to the point where medial 2/3rd and lateral 1/3rd of the line meet. Loss of resistance 2 times indicated the punctured of fascia lata and iliaca.A total volume of Ropivacaine 0.375% per body weight was given with repeated aspiration.
Experimental: 3 in 1 femoral block (FNB)
Ultrasound guided femoral 3 in 1 block using insulated stimulating needle 22 Gauge (G). Ropivacaine 0.375% as per ideal body weight.
Procedure: 3 in 1 femoral block (FNB)
The FNB was done in the OT with standard monitoring with emergency airway intervention and resuscitation drug prepared before performing intended block.Patient was put in supine position, using aseptic technique, chlorhexidine solution and draped with sterile medical towel.Lignocaine 2% for local anaesthetic infiltration at punctured site.An insulated stimulating needle (Stimuplex® D Plus 22g x 2", B Braun Melsungen AG 34209 Melsungen Germany). Ultrasound was used to locate the femoral vessel and nerve and by using 'in plane' technique, the skin was punctured with the insulated needle and advance in transverse plane at around 30 angle to the skin. Local anaesthetic solution as per ideal body weight given after negative aspiration of blood .

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The percentage of success rate between ultrasound guided femoral 3 in 1 block versus single shot blind fascia iliaca compartment block as analgesic method for positioning prior spinal anaesthesia in femur fracture surgery
Time Frame: From the time of local anaesthetic injection to successful block at least 2 out of 3 dermatomes of either lateral femoral cutaneous nerve, femoral nerve or obturator nerve up to 30 minutes.
Using pin prick to test the sensory level at different dermatomes after given local anaesthetic following each block
From the time of local anaesthetic injection to successful block at least 2 out of 3 dermatomes of either lateral femoral cutaneous nerve, femoral nerve or obturator nerve up to 30 minutes.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The onset of analgesia in term of minutes between ultrasound guided Femoral 3 in 1 nerve block versus single shot blind Fascia Iliaca Compartment Block prior positioning for spinal anaesthesia in femur fracture surgery.
Time Frame: From the time of local anaesthetic given to a reduction in visual analogue pain score to less than 2 up to 30 minutes.
assessment of the patient pain severity post local anaesthetic injection after each block by using the visual analogue pain score chart
From the time of local anaesthetic given to a reduction in visual analogue pain score to less than 2 up to 30 minutes.
The quality of blocks
Time Frame: From the sitting up the patients till successful spinal anesthesia was achieved up to 10 minutes.
The quality of positioning the patients documented by the operator prior to giving spinal anaesthesia level
From the sitting up the patients till successful spinal anesthesia was achieved up to 10 minutes.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiti Sains Malaysia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rhendra Hardy Mohamad Zaini, MD, Universiti of Science Malaysia

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

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • USM/JEPeM/15100313

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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