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CTRI Number  CTRI/2026/03/106514 [Registered on: 18/03/2026] Trial Registered Prospectively
Last Modified On: 12/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Dentistry 
Study Design  Single Arm Study 
Public Title of Study   USE OF TRAMADOL AS AN ALTERNATIVE LOCAL ANESTHETIC FOR REMOVAL OF LOWER BACK TEETH  
Scientific Title of Study   TRAMADOL HYDROCHLORIDE WITH ADRENALINE AN ALTERNATIVE LOCAL ANESTHESTIC FOR EXTRACTION OF MANDIBULAR TEETH A DOUBLE BLINDED PROSPECTIVE INTERVENTIONAL STUDY  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR JAI SWEDHA B 
Designation  MDS - Oral and Maxillofacial surgery in Sri Ramachandra Dental college  
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Department of Oral and maxillofacial surgery , Dental block room No 6
Department of Oral and maxillofacial surgery , Dental block room No 6
Chennai
TAMIL NADU
600116
India 
Phone  9080744151  
Fax    
Email  d0223002@sriher.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  DR RAVINDRAN 
Designation  MDS - Oral and Maxillofacial surgery in Sri Ramachandra Dental college  
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Department of Oral and maxillofacial surgery , Dental block room No 6
Department of Oral and maxillofacial surgery , Dental block room No 6
Chennai
TAMIL NADU
600116
India 
Phone  9841030237  
Fax    
Email  d0223002@sriher.edu.in  
 
Details of Contact Person
Public Query
 
Name  DR JAI SWEDHA B 
Designation  MDS - Oral and Maxillofacial surgery in Sri Ramachandra Dental college  
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Department of Oral and maxillofacial surgery , Dental block room No 6
Department of Oral and maxillofacial surgery , Dental block room No 6
Chennai
TAMIL NADU
600116
India 
Phone  9080744151  
Fax    
Email  d0223002@sriher.edu.in  
 
Source of Monetary or Material Support  
SELF  
 
Primary Sponsor  
Name  Dr JAI SWEDHA SELF  
Address  SRI RAMACHANDRA DENTAL COLLEGE DENTAL BLOCK ROOM NO 6 , 1 ST FLOOR  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
DR JAI SWEDHA   SRI RAMACHANDRA DENTAL COLLEGE DENTAL BLOCK ROOM NO 6 , 1 ST FLOOR  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR JAI SWEDHA   SRI RAMACHANDRA DENTAL COLLEGE  Department of Oral and maxillofacial surgery , Dental block room No 6
Chennai
TAMIL NADU 
09080744151

d0223002@sriher.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee SRU   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE  
Intervention  TRAMADOL HYDROCHLORIDE WITH ADRENALINE   USE OF TRAMADOL HYDROCHLORIDE WITH ADRENALINE AS AN ALTERNATIVE LOCAL ANESTHETIC FOR LIGNOCAINE FOR EXTRACTION OF MANDIBULAR TEETH  
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  45.00 Day(s)
Gender  Both 
Details  • Patients both males and females aged 20 – 45 years.
• Patients indicated for extraction of mandibular teeth
• ASA-I physical status patients
• Patients willing to participate in the study
 
 
ExclusionCriteria 
Details  Impacted mandibular 3rd molars
Pregnant or lactating females,
Patients with a history of drug allergy
Patients not willing to participate in the study
Patients with trismus (mouth opening less than 30 mm).
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 

• Enhanced Anesthestic duration
• Reduced Intraoperative pain

 
• Lower post operative analgesic consumption
• Enhanced Anesthestic duration
• Reduced Intraoperative pain

 
 
Secondary Outcome  
Outcome  TimePoints 
Lower post operative analgesic consumption   NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   24/03/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  02/06/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Local Anesthesia plays a crucial role in Oral and Maxillofacial surgery, ensuring patient comfort during procedures such as tooth extraction and other oral surgical procedures. Lidocaine, an amide type anesthetic , has been the gold standard due to its rapid onset, effectiveness and safety profile. However , alternative anesthetics like tramadol have gained attention for their potential local anesthetic properties , particularly in patients who are allergic to conventional agents.

Tramadol , a centrally acting opioid , has demonstrated local anesthetic properties. Several studies have compared the efficacy of tramadol versus lidocaine for dental procedures. But the mechanism on how it causes anesthetic effect is not fully understood .It has been found that Tramadol with adrenaline can be used as an alternative to lidocaine with adrenaline in terms of onset of anesthesia , duration of anesthesia , pain score via local infiltration technique .There are not enough literature to prove its effect as a nerve block  and for any procedure in mandible .This study evaluates the efficacy of Tramadol hydrochloride with adrenaline for inferior alveolar nerve block for intra alveolar extraction of mandibular posterior teeth

 

 
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