Abstract

Aims & Objectives

Introduction of regional anaesthetic techniques into modern anesthesia has revolutionized pain management. The most popular anesthetic procedure used  for mandibular anesthesia,

is the inferior alveolar nerve block (IANB). This prospective pilot trial is being undertaken

To study the efficacy of inferior alveolar nerve block for intraoperative analgesia in terms of

1.   Consumption of opioids in intraoperative period

2.   Hemodynamic stability in intraoperative period

In comparison with general anesthesia alone.

Methodology

Study setting:

This study will be conducted in the department of Anaesthesiology of Regional cancer centre, Thiruvananthapuram.

Study Design- Prospective randomized controlled trial

After a detailed pre anaesthetic check up (PAC) according to institutional protocols, patients will be randomly divided using computer generated random number tables into group A (general anaesthesia only) and group B (general anaesthesia with inferior alveolar nerve block).

Parameters noted after the block

Sensory loss will be detected in terms of loss to cold sensation and the time of onset on sensory loss will also be noted

in the following areas

1.   Numbness in the lower lip/chin

2.   Numbness in tongue

3.   Incidence of positive aspiration test

Vital charting ( Blood pressure, Heart rate) will be particularly noted at crucial events like tongue stitch, dental extraction, osteotomy, condylotomy, marginal resection along with the usual vital charting at 15 minutes interval.The vital signs and pain scoring will be noted by an independent observor who will be blinded to whether the block has been performed in the patient or not.

The primary objective of the study will be to estimate opioid  consumption to maintain hemodynamic stability in both the groups. Any raise in blood pressure or heart rate more than 20% of baseline will be managed with a bolus of fentanyl 1 mcg/kg. This dose will be repeated after 5 minutes if there is no adequate response and the number of doses and the amount of doses required will be noted.

Statistical Analysis

Sample size:

The pilot study with 10 samples in each group will be undertaken for patients fulfilling the eligibility criterion and consenting to the study.

Statistical Methods:

The categorical variables will be summarized using frequency or percentage and continuous variables using mean and standard deviation. The comparison between the groups will be done using students t-test for normally distributed continuous variables and Mann-whitney U test for non-normal variables. For comparing two categorical variables, chi-square or Fishers exact test will be used.