Comparison Between Ultrasound Guided Femoral 3 in 1 Block Versus Blind Fascia Iliaca Block Before Spinal Anaesthesia
Condition: Regional Anaesthesia
Study type: Interventional

Summary: 
      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.
    

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
    

Intervention name(s): Fascia Iliaca Compartment Block (FICB); 3 in 1 femoral block (FNB)
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; 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 .
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Fascia Iliaca Block; Femoral 3-in-1 block; Fracture femur; Spinal anesthesia