| 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
|
|
|
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
|
|
|
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
|