Femoral Fracture Clinical Trial
Official title:
Determination of the Minimum Local Anaesthetic Needed for Operative Fixation of Fractured Neck of Femur With Continuous Spinal Anaesthesia
Fixation of fractured neck of femur is a common Orthopedic surgery. Anaesthesia can be
challenging in some cases like in haemodynamical unstable patients.
The investigators have evidence of minimum effective local anaesthetic dose (MLAD) in hip
replacement surgery but MLAD to achieve surgical anaesthesia for operative fixation of FNF is
still unknown.
A step-up/step-down methodology was used successfully in regional anaesthesia and also in
other areas of anaesthesia.
In pregnant ladies in whom spinal anaesthesia is performed on the side, significant
correlation exist between the vertebral length measured from cervical 7 to the iliac creast
and MLAD.
The investigators aim it was to determine the MLAD of hyperbaric 0.5% bupivacaine required
for Continuous spinal anaesthesia for the operative fixation of FNF.
Fractured neck of femur (FNF) is a common cause of admission to hospital in elderly patients
and requires operative fixation. Spinal anaesthesia (SA) is one of the options, since 1899
when Bier described first administration this technique went through many changes. Spinal
anaesthesia has the definitive advantage that profound nerve block can be produced in a large
part of the body by the relatively simple injection of a small amount of local anaesthetic.
Although in some cases single shot SA is contraindicated or can have severe haemodynamic side
effects. In elderly patients undergoing hip fracture repair, continuous spinal anaesthesia
(CSA) provides fewer episodes of hypotension and severe hypotension compared with a single
intrathecal injection of 7.5 mg bupivacaine.
We have evidence of minimum effective local anaesthetic dose (MLAD) in hip replacement
surgery but MLAD to achieve surgical anaesthesia for operative fixation of FNF is still
unknown. It would however be beneficial for those patients who are haemodinamicaly unstable.
A step-up/step-down methodology was used successfully in regional anaesthesia and also in
other areas of anaesthesia.
In pregnant ladies in whom spinal anaesthesia is performed on the side, significant
correlation exist between the vertebral length measured from cervical 7 to the iliac creast
and MLAD.
We propose to study the MLAD for continuous spinal anaesthesia (CSA) for the operative
fixation of FNF.
Objectives: We would like to determine the MLAD of hyperbaric 0.5% bupivacaine required for
CSA for the operative fixation of FNF.
After ethical approval and having obtained appropriate consent we will start recruitment to
the study.
Patients will receive no premedication prior to their arrival to the operating room. All
patients will receive oxygen (35% oxgen Venturi facemask) during the procedure, including the
first postoperative hours. Standard monitoring including continuous electrocardiogram,
noninvasive automated arterial blood pressure and pulse oximetry will be applied. Patients
will receive ultrasound guided femoral nerve block, 15 ml of 2% lignocaine before being
turned to the lateral position for lumbar puncture. After antiseptic preparation of the area,
lumbar puncture will be performed by an experienced senior anesthesiologist.
Subarachnoid puncture will be performed with a 18-gauge Tuohy needle at the L4-5 or L3-4
interspace using a midline approach. Three cm of a 22-gauge catheter will be introduced
cephalad through the needle. The initial dose is arbitrarily chosen as 1 ml of 0.5 % isobaric
bupivacaine on the basis of clinical experience, the local anaesthetic will be injected
through the catheter over 5-10 s. After completion of injection the patients remain in the
lateral position for 5 min and then will be returned to the supine position.
Successive injections of 0.2 ml of 0.5 % isobaric bupivacaine will be performed every 15 min
until a satisfactory sensory level is obtained (T12).
Using a step-up/step-down model, the dose used for following patients will be determined by
the outcome of the preceding intrathecal block. In the case of failure of the initial dose
when there is a need to administer extra dose of local anaesthetic after 15 minutes, the
initial dose will be increased by 0.1 ml. Conversely, spinal success will result in a
reduction in dose by 0.1 ml.
Noninvasive automated blood pressure and heart rate measurements will be recorded before the
spinal anesthesia (baseline) and every three minutes after the end of local anesthetic
injection till the end of surgery.
Hypotension is defined as a decrease of more than 20% from the baseline systolic arterial
blood pressure (SAP). Severe hypotension is defined as a decrease in SAP more than 30% of
baseline value. Hypotension will be treated with IV boluses of ephedrine 6 mg if the heart
rate is below 60/minutes or phenylephrine 100 microgramm if the heart rate is above
60/minutes.
In case of failure or insufficient block, general anesthesia will be performed. A blinded
observer will be assessing the dermatome level of sensory blockade with an ice-cold test
(ethyl-chloride spray) bilaterally after injection of the local anesthetic. Block assessment
will be performed at 15min intervals up to 45 min after completion of the initial intrathecal
injection. The modified Bromage scale (0 - non-motor block; 1 " hip flexion with extended leg
blocked, 2-knee flexion blocked, 3-complete motor block) will be used for degree of motor
block bilaterally. Sensory function will be scored as being present or absent. Surgical
anesthesia is defined as a with absent appreciation of cold sensation. The time interval at
which surgical anesthesia is achieved will be noted. Total spinal anaesthesia failure is
defined as absence of surgical anesthesia at 45 min.
The number of hypotensive episodes, total vasopressor administered, and the iv. fluid infused
will be recorded. Catheters in the CSA group were removed after the surgery.
All patients will be receiving 1 g of intravenous paracetamol and 75 mg of diclofenac sodium
during surgery. Postoperative analgesia will consist of 1 g of oral paracetamol every 6 hours
and 75 mg of diclofenac sodium twice daily for 72 h after surgery. Oxycodone 5 mg will be
prescribed for rescue analgesia after spinal anaesthesia regression.
Study-stopping Rules
Based on previous non-probability sequential dosing, up-and-down dose finding studies with
similar binary outcomes. We are estimating that a minimum of five independent negative
positive up-and-down deflections are required to calculate MLAD.
;
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