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CTRI Number  CTRI/2024/11/077202 [Registered on: 21/11/2024] Trial Registered Prospectively
Last Modified On: 20/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the effectiveness of mandibular nerve block and systemic analgesia intra operatively to reduce total opioid consumption in post operative period in cases of mandibular fracture posted for open reduction and internal fixation 
Scientific Title of Study   A Randomized Comparative Study to Assess the Effectiveness of USG Guided Mandibular Nerve Block Using 0.5 percentage Ropivacaine for Post-Operative Pain Reduction in Cases of Fracture Mandible Posted for Open Reduction and Internal Fixation in Department of Anaesthesia, SMS Medical College, Jaipur. 
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 VANDANA MANGAL  
Designation  Senior professor 
Affiliation  sawai man singh medical college jaipur 
Address  Department of anaesthesia, trauma centre ot, SMS medical college, jaipur

Jaipur
RAJASTHAN
302001
India 
Phone  9829056816  
Fax    
Email  vandanamangal25@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR VANDANA MANGAL  
Designation  Senior professor 
Affiliation  sawai man singh medical college jaipur 
Address  Department of anaesthesia, trauma centre ot, SMS medical college, jaipur

Jaipur
RAJASTHAN
302001
India 
Phone  9829056816  
Fax    
Email  vandanamangal25@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chandana S M 
Designation  Junior Resident  
Affiliation  Sawai Man Singh medical college, Jaipur  
Address  Department of anesthesia, 2nd floor trauma centre ,SMS medical College, jaipur

Jaipur
RAJASTHAN
302001
India 
Phone  9113969505  
Fax    
Email  chandanamanjunaths@gmail.com  
 
Source of Monetary or Material Support  
trauma center ot, 2nd floor, department of anesthesia, SMS medical College, JaipurRajasthan 302001 
 
Primary Sponsor  
Name  SMS Medical College Jaipur 
Address  trauma center ot, 2nd floor, department of anesthesia, SMS medical College, Jaipur Rajasthan 302001 India  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr vandana mangal   SMS Medical College   trauma center ot, 2nd floor, department of anesthesia, SMS medical College, Jaipur, Rajasthan 302002
Jaipur
RAJASTHAN 		 9829056816

vandanamangal25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Office of the ethics committee ,SMS medical college and attached hospital ,Jaipur   Approved 
Office of the ethics committee ,SMS medical college and attached hospital ,Jaipur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: S026||Fracture of mandible,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Inj. Tramadol 100 mg IV in intraoperatively   Patients will receive Inj Tramadol 100 mg IV after induction of general anesthesia with 90 minutes  
Intervention  USG guided mandibular nerve block using 10 ml of 0.5 percent ropivacaine   USG guided mandibular nerve block using 10 ml of 0.5 percentage ropivacaine after induction of general anesthesia with in 15 minutes  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients posted for ORIF of fracture of mandible
2.Patients consenting to participate.
3.Adult patients aged 18 years -60 years.
4.Patients belonging to American Society of Anaesthesiologists (ASA) grade I and II 
 
ExclusionCriteria 
Details  1.Patients part of other study
2.Non co-operative patients
3.H/O allergic reactions to local anesthetics
4.coagulation disorders.
5.Local infection at the proposed site of puncture for mandibular nerve block.
6.Fracture of symphysis
7.pregnant patients
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Mean NRS score at different time interval in post operative period 24 hours after surgery
2.Mean time for first rescue analgesia.
3.Total consumption of opioids during first 24 hours 		 at baseline ,3rd hour ,6rd hour ,9th hour ,12th hour,24 th hourly in post operative period 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic variables (HR, SBP, DBP, MAP, SpO2) in first 24 hours
Proportion of cases with complications in first 24 hours .
 		 at baseline ,3rd hour ,6th hour,9th hour,12th hour ,24 hourly in post operative period  
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   01/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/12/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

The surgery for mandibular fracture fixation can cause severe pain in the immediate postoperative period. Most of these patients are managed with intravenous opioids. Mandibular nerve block provides good perioperative analgesia for mandibular surgeries. They can be used as part of multimodal analgesia to reduce the consumption of opioids in the postoperative period. The purpose of pre-emptive analgesia is not only to provide better postoperative analgesia but also to reduce the consumption of opioids and anesthetic agents intraoperatively.

•Our study aims to compare the consumption of opioid for 24 hours in both groups postoperatively in cases  mandible fracture surgeries undergoing ORIF by using  0.5% ropivacaine  and to compare the time for a request for rescue analgesic, intraoperative hemodynamic parameters and Numerical Rating Scale (NRS) scores for 0,3,6,9,12 and 24 hour postoperatively.
 
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