Mandibular Neoplasms Clinical Trial
Official title:
Inferior Alveolar Nerve Block for Intraoperative Analgesia for Maxillofacial Cancer Surgery Requiring Unilateral Mandibular Resection-A Randomized Controlled Study
Mandibular resection which is an important component of maxillofacial cancer surgery is an extremely painful procedure associated with severe sympathetic response needing high doses of opioids. Inferior alveolar nerve block is a common nerve block used by dentists for mandibular dental extractions. The aim of this trial is to study the effect of this block for intraoperative analgesia in maxillofacial cancer surgeries requiring unilateral mandibular resection.
All adult patients below 75yrs of age scheduled for maxillofacial surgery will be screened
for inclusion and exclusion criteria.
Written informed consent will be taken one day prior to surgery. Consenting subjects will be
randomized after induction of anaesthesia to study or control arm.
The duration of the study is from induction of anaesthesia to the completion of primary
tumour removal and neck dissection
Study procedure: Ipsilateral Inferior alveolar nerve block A long acting local anaesthetic
agent Inj Bupivacaine hydrochloride 0.5% (2 ml) will be given after induction by open mouth
technique by landmark method.
The mucobuccal fold will be palpated and traced till coronoid notch. The finger will be
moved medially across the retromandibular trigone on internal oblique ridge. The 25G needle
will be inserted till bone is felt. 2 ml of 0.5% bupivacaine will be injected slowly after
withdrawing needle by 1mm and confirming negative aspiration of blood.
Control arm will not receive any intervention. The study investigator will give a mock
injection for blinding of the attending anaesthetist
The study procedure will be done by the study investigators 10 -30 minutes prior to
commencing surgery for primary tumour.
Account of procedure:
All patients will have standard conduct of anaesthesia except for the alveolar nerve
injection in the study group.
All patients will have the minimum standard monitoring of pulse oximeter, electrocardiogram,
capnography and non invasive blood pressure monitoring.
Blood pressure and heart rate will be recorded every 5 min interval from the beginning till
completion of primary tumor excision and neck dissection
Induction of anaesthesia: IV fentanyl 2 mcg/kg, IV Propofol 2 -3 mg/kg. IV neuromuscular
blocking agent used will be Inj vecuronium bromide in the dose of 0.1 mg /kg. All patients
will have standard airway management at the discretion of the attending anaesthesiologist.
Intraoperative maintenance of anaesthesia will be as follows
1. Controlled ventilation with isoflurane in air / oxygen with minimal alveolar
concentration of 0.8 -1.2
2. Intraoperative analgesic - IV fentanyl in boluses of 1 mcg/kg at the discretion of the
anaesthetist based on the haemodynamic response till the completion of primary tumour
removal and neck dissection. Thereafter, the choice of analgesic will be left to the
anaesthetist
3. In case of uncontrolled sympathetic response (hypertension and/or tachycardia) to
surgery not controlled by IV fentanyl (10 mcg/kg ), rescue intraoperative analgesic/
anaesthetic (e.g.IV morphine, IV diclofenac, IV dexmedetomide, IV propofol, increase in
inhalational anaesthetic concentration, etc) or vasoactive agents (e.g.IV Esmolol, IV
Nitroglycerin, etc) may be used. This will be noted in the Case record form.
Information will be collected as per Case Record form by the investigator. Any deviation
from protocol will be recorded.
Sample size calculation Based on the average fentanyl requirement 340mcg found in pilot
data, to detect 25% reduction in fentanyl requirement in the study group compared to control
group, with 80% power and level of significance of 5% ,the sample size calculated was 22 in
each group.
Statistical Analysis The fentanyl requirement in the two groups, maximum heart rate and
maximum blood pressure will be will be compared using students t test Other variables will
be described as numbers and percentage
Demographic ,clinical and disease relate variable will be present as frequency (percentage)
and mean (S.D.) or median as appropriate.
Two group comparisons will be made using independent t-test or Man Whitney U test as per
distribution of the data.
P-value< 0.05 will be considered statistical significant. Repeated measures ANOVA will be
used to compare change of blood pressure and heart rate from baseline at various time
points.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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