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    Sanskriti Synopsis

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    This document provides information for the registration of a dissertation presented by Dr. Sanskriti Shah at Vokkaligara Sangha Dental College & Hospital. The dissertation will assess the safety and efficacy of 0.5% bupivacaine and 0.75% ropivacaine in patients undergoing mandibular third molar surgery. It will be a randomized split mouth crossover study involving 60 impacted teeth in 30 subjects. The objectives are to compare the onset of action, duration of action, hemodynamic changes, and adverse drug reactions of the two local anesthetics. The methodology, inclusion/exclusion criteria, investigations required and references are also outlined.

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    Sanskriti Synopsis

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    This document provides information for the registration of a dissertation presented by Dr. Sanskriti Shah at Vokkaligara Sangha Dental College & Hospital. The dissertation will assess the safety and efficacy of 0.5% bupivacaine and 0.75% ropivacaine in patients undergoing mandibular third molar surgery. It will be a randomized split mouth crossover study involving 60 impacted teeth in 30 subjects. The objectives are to compare the onset of action, duration of action, hemodynamic changes, and adverse drug reactions of the two local anesthetics. The methodology, inclusion/exclusion criteria, investigations required and references are also outlined.

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    This document provides information for the registration of a dissertation presented by Dr. Sanskriti Shah at Vokkaligara Sangha Dental College & Hospital. The dissertation will assess the safety and efficacy of 0.5% bupivacaine and 0.75% ropivacaine in patients undergoing mandibular third molar surgery. It will be a randomized split mouth crossover study involving 60 impacted teeth in 30 subjects. The objectives are to compare the onset of action, duration of action, hemodynamic changes, and adverse drug reactions of the two local anesthetics. The methodology, inclusion/exclusion criteria, investigations required and references are also outlined.

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    Download as pptx, pdf, or txt
    28 views16 pages

    Sanskriti Synopsis

    Uploaded by

    sanskriti_14
    This document provides information for the registration of a dissertation presented by Dr. Sanskriti Shah at Vokkaligara Sangha Dental College & Hospital. The dissertation will assess the safety and efficacy of 0.5% bupivacaine and 0.75% ropivacaine in patients undergoing mandibular third molar surgery. It will be a randomized split mouth crossover study involving 60 impacted teeth in 30 subjects. The objectives are to compare the onset of action, duration of action, hemodynamic changes, and adverse drug reactions of the two local anesthetics. The methodology, inclusion/exclusion criteria, investigations required and references are also outlined.

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    SYNOPSIS FOR DISSERTATION

    GUIDED BY:
    Dr. MADAN N
    DEPT. OF ORAL& MAXILLOFACIAL SURGERY

    PRESENTED BY :
    Dr. SANSKRITI SHAH
    POST GRADUATE
    OMFS
    PROFORMA FOR REGISTRATION OF SUBJECTS FOR
    DISSERTATION
    NAME AND ADDRESS OF THE
    1. 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 MASTER OF DENTAL


    SUBJECT SURGERY
    ORAL AND MAXILLOFACIAL
    SURGERY

    4. DATE OF ADMISSION 17/12/2021


    TO THE COURSE
    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
    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.
    • 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.
     
    AIM OF THE STUDY
    To evaluate the safety and efficacy of 0.5% bupivacaine and 0.75%
    ropivacaine in patients undergoing mandibular third molar surgery.

    OBJECTIVES OF THE STUDY


    • 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.
    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
    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.
    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.
    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.
    • 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  
    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.
    Investigations required:
    • Routine blood investigations
    • Radiographs: Orthopantomogram (OPG),IOPAR.
    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).
     
    • Nazeer J, Kumari S, Haidry N, Kulkarni P, Aastha, Gautam A, Gupta P. Comparison of
    efficacy of lignocaine, ropivacaine, and bupivacaine in pain control during extraction of
    mandibular posterior teeth. Natl J Maxillofac Surg. 2021 May-Aug;12(2):238-243
     
    • Robert D'Angelo, Robert L. James; Is Ropivacaine Less Potent than
    Bupivacaine? . Anesthesiology 1999; 90:941–943
    THANK YOU….

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