| CTRI Number |
CTRI/2025/03/083615 [Registered on: 27/03/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Inferior alveolar nerve block for patients undergoing mandibular fracture repair for pain releif |
|
Scientific Title of Study
|
A Randomized control study on analgesic efficacy of inferior alveolar nerve block for maxillofacial trauma surgery under general anesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AMAL BHARGAVAN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
INSTITUTE OF MEDICAL SCIENCES
BANARAS HINDU UNIVERSITY
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8592952969 |
| Fax |
|
| Email |
amalb0608@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ATUL KUMAR SINGH |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
INSTITUTE OF MEDICAL SCIENCES
BANARAS HINDU UNIVERSITY
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8317010317 |
| Fax |
|
| Email |
atulksingh84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
CHANDRESH JAISAWRA |
| Designation |
PROFESSOR |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY |
| Address |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY
INSTITUTE OF MEDICAL SCIENCES
BANARAS HINDU UNIVERSITY
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9451153809 |
| Fax |
|
| Email |
drchandresh@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Banaras Hindu University, Institute of Medical Sciences,Varanasi 221005,Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Sciences |
| Address |
Department of Anaesthesiology
Institute of Medical Sciences Banaras Hindu University Varanasi 221005, Uttar Pradesh, India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ATUL KUMAR SINGH |
INSTITUTE OF MEDICAL SCIENCES |
DEPARTMENT OF ANAESTHESIOLOGY AND DEPARTMENT OF ORAL MAXILLOFACIAL SURGERY
INSTITUTE OF MEDICAL SCIENCES
BANARAS HINDU UNIVERSITY
Varanasi
UTTAR PRADESH |
8317010317
atulksingh84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Banaras Hindu University, Institute of Medical Sciences,Institutional Ethics Committee, Varanasi 221005 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S026||Fracture of mandible, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.5% isobaric ropivacaine |
0.5% isobaric ropivacaine 2 ml given to block inferior alveolar nerve through oral route |
| Comparator Agent |
0.9% normal saline |
0.9% normal saline 2 ml given to block inferior alveolar nerve through oral route |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients undergoing mandibular fracture repair under general anesthesia are to be given inferior alveolar nerve block |
|
| ExclusionCriteria |
| Details |
patients with cardiac problems, hemodynamic instability, allergy to the drug proposed to be administered |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| analgesic efficacy of inferior alveolar nerve block for repair of mandibular fracture |
analgesic efficacy of inferior alveolar nerve block for repair of mandibular fracture upto 6 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
rescue analgesic requirement
patient satisfaction in postoperative period |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/04/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Maxillofacial injuries are common in patients with road traffic accidents. Those with mandibular fracture/s are supposed to undergo repair with plating so that normal routine activities can be performed after healing. Our purpose is to give the Inferior alveolar nerve block which supply mandible, for intraoperative and postoperative pain relief. This also decreases the requirement of intravenous analgesics and their side effects. |