2. 1. NAME AND ADDRESS OF THE
CANDIDATE
Dr. SANSKRITI SHAH
DEPARTMENT OF ORAL AND
MAXILLOFACIAL SURGERY
VOKKALIGARA SANGHA
DENTAL COLLEGE &
HOSPITAL, K.R. ROAD,
BANGALORE-560004
2. NAME OF THE INSTITUTION VOKKALIGARA SANGHA
DENTAL COLLEGE &
HOSPITAL, K.R.
ROAD,BANGALORE-560004
3. COURSE OF THE STUDY AND
SUBJECT
MASTER OF DENTAL
SURGERY
ORAL AND MAXILLOFACIAL
SURGERY
4. DATE OF ADMISSION 17/12/2021
PROFORMA FOR REGISTRATION OF SUBJECTS FOR
DISSERTATION
3. TITLE OF THE TOPIC
ASSESSMENT OF SAFETY AND EFFICACY OF 0.5%
BUPIVACAINE AND 0.75% ROPIVACAINE IN PATIENTS
UNDERGOING MANDIBULAR THIRD MOLAR SURGERY-
A RANDOMIZED SPLIT MOUTH CROSSOVER STUDY
4. NEED FOR THE STUDY
• The third molar extraction is one of the most common surgical procedures
in oral surgery and is usually accompanied by post-operative discomforts.
• Local anesthetic agents are the mainstay of peri operative pain control for
most office based oral surgical procedures.
• For many decades 2% lidocaine with epinephrine was the usual and
preferable local anesthetic in everyday dental practice it’s relatively quick
onset (2 minutes) and a medium range of soft tissue anesthesia (190
minutes) potentiates it as successful everyday working local anesthetic,
however surgical procedures favors local anesthetics for long lasting local
anesthesia because they reduce the need for postoperative analgesic drugs.
Surgical trauma and resulting inflammation cause sensitization of
nociceptive receptors from where neural impulse take postoperative period
of 8–12 h during which maximum pain intensity is achieved. Thus, longer
acting local anesthetic agents demonstrates better role in controlling
postoperative pain when compared to the short-acting local anesthetics.
5. • Bupivacaine (1-butyl-2’, 6’-pipecoloxylidide) is a long-acting amide-type
local anesthetic which was first introduced for clinical usage in 1963. It
has longer duration of action due to higher lipid solubility and
protein-binding capability. It has residual analgesia property
postoperatively whereas lignocaine demonstrates severe postoperative
pain with wearing off of its anesthetic effects.
• Ropivacaine (1’-propyl-2’,6’-pipecoloxylidide ) is a long-acting amide
local anesthetic agent. Its has physicochemical property similar to that of
bupivacaine. It is medium to long duration acting local anesthetic of the
class-amino amide. It is a pure S-enantiomer when compared to other
local anesthetics which are racemic mixtures. This anesthetic agent
produces peripheral nerve anesthetic action of longer duration compared
to the R or racemic forms.
6. AIM OF THE STUDY
OBJECTIVES OF THE STUDY
To evaluate the safety and efficacy of 0.5% bupivacaine and 0.75%
ropivacaine in patients undergoing mandibular third molar surgery.
• To compare the onset of action.
• To compare the duration of action.
• To monitor the hemodynamic changes and vitals after administration of the
local anaesthetic agent.
• To monitor adverse drug reactions.
7. MATERIALS AND METHODS
Source of data:
• The study will be conducted on subjects requiring surgical extraction
of bilaterally impacted mandibular third molars taking into
consideration the exclusion and inclusion criteria reporting to the
department of oral and maxillofacial surgery, VS Dental college and
hospital, Bengaluru.
Methods of collection of data:
• Study subjects: Patients with bilaterally impacted mandibular
third molars.
• Study Design : Randomized Split mouth crossover study
• Study Duration : 18 months
• Sample Size :60 impacted teeth in 30 subjects divided into 2
groups:
• Group A – Bupivacaine group
• Group B – Ropivacaine group
• Statistical analysis: Student t test
8. INCLUSION CRITERIA:
• Age: 18 and above
• Subjects requiring surgical removal of bilaterally impacted mandibular
third molars.
• Subjects under ASA I and II category.
• Subjects who are willing to participate and sign the written informed
consent.
9. EXCLUSION CRITERIA:
• Patients who are allergic or hypersensitive to any of the drugs used in the study.
• Pregnant and lactating women.
• Subjects with active infections.
• Subjects with neuromuscular disorders.
• Subjects under ASA III – VI category.
• Patients not willing for the study.
10. METHODOLOGY :
• The patients will be randomly selected and the study will be done to evaluate
the safety and efficacy of 0.5% Bupivacaine (GROUP A) and 0.75%
Ropivacaine (GROUP B) given on either side of bilaterally impacted
mandibular third molars. It will be given by classical inferior alveolar nerve
block at the beginning of the procedure.(1.5 mL for inferior alveolar nerve
anesthesia, 0.3 mL for lingual nerve anesthesia, and 0.2 ml for buccal nerve
anesthesia)
• The study design will be discussed with every selected subject and his/her
written consent will be taken prior to commencement of the study.
• Prior to the surgery a brief case history of every subject will be taken.
• The diagnosis will be made on the basis of history, clinical and the radiological
examination.
• The subjects will be given antibiotics and analgesics. (Tab Amoxicillin 500mg
in combination with clavulanic acid 125mg BD for 5 days, Tab Metrogyl
400mg TID for 3 days, Tab Divon Plus BD for 3 days, Tab Chymoral Forte BD
for 3 days, Tab Pan D OD for 5 days.)
• The surgeries will be done after one month.
11. • The procedures will be done by same operating surgeon.
• Baseline measurements will be as mentioned below:
Onset of action
It will be determined by noting down the subjective and objective symptoms.
Subjective symptoms being - tingling or numbness of the lower lip and tongue
at the beginning of the procedure
Objective symptoms being - no pain during the pin prick test.
Duration of anesthesia
The duration of anesthesia will be assessed from the start of Grade 2 to the
shift of the score back to Grade 1.
The sensory blockade will be graded as
• Grade 0 - Sharp pain felt
• Grade 1 - Analgesia, dull sensation felt
• Grade 2 – Anesthesia, no sensation felt
12. Hemodynamic changes and vitals
The patient will be monitored for blood pressure and pulse oximetry will be
used to record the heart rate, oxygen saturation, respiratory rate.
The readings will be taken at different time points i.e before the start of the
procedure, after the end of the procedure and after wear off of anesthetic
effect.
Adverse reactions
The patients will be asked to report if presence of any adverse reaction such
as dizziness, convulsions, seizures, palpitations, breathlessness, restlessness,
tinnitus, chest pain after discharge.
The presence or absence of adverse reactions will be assessed till 7 days via
telephonic conversation.
15. REFERENCES
• B.M.B. Brkovic, M. Zlatkovic, D. Jovanovic, D. Stojic, Maxillary infiltration
anaesthesia by ropivacaine for upper third molar surgery, International Journal of
Oral and Maxillofacial Surgery,Volume 39, Issue 1,2010,Pages 36-41, ISSN 0901-
5027
• Kuthiala, Gaurav, and Geeta Chaudhary. “Ropivacaine: A review of its pharmacology
and clinical use.” Indian journal of anaesthesia vol. 55,2 (2011): 104-10.
• Tijanic M, Buric N. A randomized anesthethic potency comparison between
ropivacaine and bupivacaine on the perioperative regional anesthesia in lower third
molar surgery. Journal of Cranio-maxillo-facial Surgery : Official Publication of the
European Association for Cranio-maxillo-facial Surgery. 2019 Oct;47(10):1652-1660
• Kaur, K., Kaur, T., Kapila, S. et al. Evaluation of Anesthetic Efficacy of 4% Articaine,
0.5% Bupivacaine and 0.5% Ropivacaine During Surgical Removal of Impacted
Mandibular Third Molars: A Randomized Comparative Clinical Study. J. Maxillofac.
Oral Surg. (2021).
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of efficacy of lignocaine, ropivacaine, and bupivacaine in pain control during
extraction of mandibular posterior teeth. Natl J Maxillofac Surg. 2021 May-
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• Robert D'Angelo, Robert L. James; Is Ropivacaine Less Potent than
