A clinical study to determine the effectiveness of 2% lignocaine with varying concentration of adrenaline used in dental extraction procedures.
- Conditions
- Disorder of teeth and supporting structures, unspecified,
- Registration Number
- CTRI/2022/07/044039
- Lead Sponsor
- Self Dr Namrata Patil
- Brief Summary
Local anaesthetics are used to carry out minor surgical procedures in dentistry. They ensure a painless procedure especially during manipulation of mucosa and bone and thereby proved to minimize anxiety in patients.
Vasoconstrictors are added to improve the efficiency of the local anaesthetic agent by reducing the rate of absorption from the site of administration thereby minimizing toxicity and prolonging the duration of action. It also reduces haemorrhage thus ensuring a bloodless field for the procedure. Advent of adrenalized local anaesthesia solutions and their ease of administration have enabled the surgeon to perform minor surgeries on a walk in and walk out basis for needy patients and for those patients unfit for general anaesthesia.
Systemically adrenaline like vasoconstrictors are known to trigger cardiovascular disturbances. These range from tachycardia and raised blood pressure to ventricular fibrillation, myocardial infarction and cerebrovascular accidents. While most are short lived due to rapid absorption and metabolism of adrenaline, the potential risk of serious outcomes increases the chance of threat to life of the patient. Due to the risk of these occurrences adrenalized local anaesthetics are contraindicated for use by cardiologists in patients with known history of hypertension or cardiac disease. However, plain local anaesthesia solutions suffer from the problem of inadequate depth and duration of anaesthesia. This leads to increased endogenous catecholamine release due to the anxiety and fear experienced by the patient secondary to the pain felt at the surgical site thus increasing the potential risk for cardio/cerebrovascular events.
In present times due to various factors such as increased stress faced in daily life, the younger population in the 4th decade of life has a significant number of silent members with cardiac disease such as hypertension and coronary insufficiency. Use of adrenalized LA agents in such subjects with silent cardiac disease during dental procedures may therefore prove to be risky to the patient and invite medico-legal action against the surgeon.
In view of the increasing incidence of silent cardiac disease in younger population as well as increase in number of senior citizens with known cardiac disease seeking dental surgery this study is proposed to find a golden mean with respect to the safe concentration of adrenaline from the view point of maintaining the efficacy of local anaesthetic without increasing the risk potential to patients with covert/overt cardiac disease.
At present 2% lignocaine HCL combined with adrenaline in a concentration of 1: 200000 is the most widely used local anaesthetic solution for dental procedure. Patient comfort during extraction and endodontic therapy remain the gold standard for measuring of the local anaesthetic efficacy. In this study it is proposed to compare the efficacy of 2% plain lignocaine with 2% lignocaine combined with adrenaline 1:400000 to 2% lignocaine combined with 1:200000 as the standard (control) solution. The efficacy will be tested on willing patients needing a maxillary molar/premolar extraction in the cardiac risk prone age group of 40-60 years. Pre and post injection blood pressure and pulse will be used as parameters to monitor the haemodynamic changes. Post extraction bleeding will be recorded 30 minutes after the extraction procedure to evaluate the need for suturing for control of post operative bleeding following extraction in all three groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 75
- Individuals falling in 40-60 age group.
- individuals needing maxillary molar/premolar extractions.
- Individuals with controlled hypertension.
- Individuals with known H/O of thyroid disorder, renal disease , uncontrolled hypertension ,under antiplatelets & anticoagulant therapy , bronchial asthma and pregnant females Patients with known allergy to any of the study drugs.
- Mentally challenged patients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain measured by Visual Analog Scale 5 minutes
- Secondary Outcome Measures
Name Time Method Pulse Beats per minute before and after injection of local anesthetic and immediately after extraction procedure Need for suturing yes/no Blood pressure Mm of Hg by automated sphygmomanometer before and after LA injection and immediately after completion of the extraction procedure. Volume of anesthetic agent ml
Trial Locations
- Locations (1)
Department of Oral and Maxillofacial Surgery (1st floor)Nair Hospital Dental College
🇮🇳Mumbai, MAHARASHTRA, India
Department of Oral and Maxillofacial Surgery (1st floor)Nair Hospital Dental College🇮🇳Mumbai, MAHARASHTRA, IndiaDr Namrata PatilPrincipal investigator9867277017drnamratapatil10@gmail.com