Regional Anaesthesia Clinical Trial
Official title:
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.
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
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