Inferior Alveolar Nerve Block for Intraoperative Analgesia for Maxillofacial Cancer Surgery - RCT
Condition: Mandibular Neoplasms
MeSH terms: Mandibular Neoplasms
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): inferior alveolar nerve block
Intervention type(s): Procedure
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment