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CTRI Number  CTRI/2025/08/093585 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 24/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison of Efficacy of Ropivacaine with or without dexamethasone and Bupivacaine with or without dexamethasone for Local Anesthesia in open reduction and internal fixation of Mandible Fractures: A Triple-Blind Randomized Controlled Trial 
Scientific Title of Study   Efficacy of Ropivacaine with or without dexamethasone and Bupivacaine with or without dexamethasone for Local Anesthesia in open reduction and internal fixation of Mandible Fractures: A Triple-Blind Randomized Controlled Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Divyesh Kumar Tanwar 
Designation  postgraduate resident 
Affiliation  Maulana Azad Institute of Dental Sciences 
Address  1st floor, dept of oral and maxillofacial surgery,MAIDS, Bahadurshah zafar marg, delhi gate

New Delhi
DELHI
110002
India 
Phone  9414407001  
Fax    
Email  divyeshtanwar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Sujata mohanty 
Designation  professor and head of department 
Affiliation  Maulana Azad Institute of Dental Sciences 
Address  room no. 124,1st floor, department of oral and maxillofcial surgery, maulana azad institute of dental sciences Bahadurshah zafar marg, delhi gate

New Delhi
DELHI
110002
India 
Phone  9654700960  
Fax    
Email  drsujatam@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Divyesh Kumar Tanwar 
Designation  postgraduate resident 
Affiliation  Maulana Azad Institute of Dental Sciences 
Address  1st floor, dept of oral and maxillofacial surgery,MAIDS, Bahadurshah zafar marg, delhi gate
house no. 1, near kendriya bhandar, MAMC campus, Bahadurshah zafar marg, delhi gate
New Delhi
DELHI
110002
India 
Phone  9414407001  
Fax    
Email  divyeshtanwar@gmail.com  
 
Source of Monetary or Material Support  
none 
 
Primary Sponsor  
Name  divyesh kumar tanwar 
Address  house no 1, near kendriya bhandar, MAMC campus Bahadurshah zafar marg, delhi gate 
Type of Sponsor  Research institution and hospital 
 
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 
Divyesh kumar Tanwar   Maulana Azad Institute of Dental Sciences  1st floor,minor OT room, dept of oral and maxillofacial surgery,MAMC Campus, Bahadur Shah Zafar Marg, New Delhi, Delhi, 110002
New Delhi
DELHI 		 9414407001

divyeshtanwar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  group 1- ropivacaine  efficacy of 4 ml of Ropivacaine (0.75%) given as Inferior alveolar nerve block (1.5ml), Long buccal nerve block (0.3ml) Lingual nerve block(0.4ml) and Local infiltration at peri-incisional site(1.8ml) for patient undergoing open reduction and internal fixation of mandible fracure. duration upto February 2027 
Comparator Agent  group 2- bupivacaine  efficacy of 4 ml bupivacaine (0.5%) given as Inferior alveolar nerve block (1.5ml), Long buccal nerve block (0.3ml) Lingual nerve block(0.4ml) and Local infiltration at peri-incisional site(1.8ml) for patient undergoing open reduction and internal fixation of mandible fracure. duration upto February 2027 
Intervention  group 3- ropivacaine with dexamethasone  efficacy of 4 ml of Ropivacaine (0.75%) with 1 ml of dexamethasone (4mg/ml) given as Inferior alveolar nerve block (2.5ml), Long buccal nerve block (0.3ml) Lingual nerve block(0.4ml) and Local infiltration at peri-incisional site(1.8ml) for patient undergoing open reduction and internal fixation of mandible fracure.duration upto February 2027 
Intervention  group 4- bupivacaine with dexamethasone  efficacy of 4 ml of bupivacaine (0.5%) with 1 ml of dexamethasone (4mg/ml) given as Inferior alveolar nerve block (2.5ml), Long buccal nerve block (0.3ml) Lingual nerve block(0.4ml) and Local infiltration at peri-incisional site(1.8ml) for patient undergoing open reduction and internal fixation of mandible fracure. duration upto February 2027 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Diagnosed with unilateral, isolated, mandibular fractures confined to the dentate segment
requiring ORIF through intra oral approach, confirmed clinically and radiographically.
Medically fit to undergo surgery under local anesthesia.
4. Willing to provide informed consent and comply with follow-up visits. 
 
ExclusionCriteria 
Details  1. Patients with additional facial fractures, bilateral mandibular fractures, comminuted
fracture, or fractures which require treatment under general anesthesia.
2. History of allergy to local anesthetics or corticosteroids.
3. Patients with systemic conditions affecting healing, such as diabetes, hypertension,
osteoporosis, or immunosuppression.
4. Fractures with significant bone loss requiring bone grafting. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate pain levels intraoperatively and postoperatively.
2. Record the duration of Analgesia 		 1. pain levels intraoperatively and postoperatively at 2,4,6,8 hour respectively.
2.Duration of Analgesia- time interval between the onset of anesthesia and the
patient’s first request for rescue analgesia 
 
Secondary Outcome  
Outcome  TimePoints 
1.reduction in post operative extraoral swelling .
2.incidence of Complications
3.Safety Profile of Anesthetic-Steroid Combinations
4.duration of surgical procedure.  		 1. Swelling: Preoperative swelling will be assessed as a mean of a 4-line measurement using
a plastic measuring tape (line 1, gonion to lateral canthus of eye; line 2, tragus to commissure
of lip; line 3, tragus to midline in chin; line 4, tragus to ala) and at subsequent follow-ups at
1,3,7th day.
2. Safety Profile: Record any adverse events related to the use of local anesthetics or
dexamethasone (e.g., hypersensitivity reactions, delayed healing), infection rate and
monitoring vitals. A drug reporting form standardized by the Department of Pharmacology;
MAMC will be used to report any adverse drug reactions
3.complication assessment form will be filled to record any
anesthesia related or surgery related complications in the patient
4. Duration of surgical procedure will be measured from the
incision placement till closure of the incision 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   05/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="1"
Days="1" 
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   Mandibular fractures, the second most common facial fractures after nasal fractures, often require open reduction and internal fixation (ORIF) for optimal anatomical and functional recovery. Effective intraoperative anesthesia and prolonged postoperative analgesia are crucial for patient comfort, reduced complications, and faster recovery. This triple-blind randomized controlled trial aims to compare the efficacy of ropivacaine (0.75%) and bupivacaine (0.5%), each with or without dexamethasone (4 mg/ml), in unilateral isolated mandibular fractures managed via ORIF. Thirty-two patients, meeting strict inclusion criteria and randomized into four equal groups, will undergo standardized local anesthesia techniques, including inferior alveolar, lingual, long buccal nerve blocks, and peri-incisional infiltration. Primary outcomes include intraoperative and postoperative pain scores (Visual Analogue Scale) and duration of analgesia, defined as the time to first rescue analgesic. Secondary outcomes include postoperative swelling (four-line measurement method), incidence of complications, safety profile, and surgical duration. Literature suggests that ropivacaine offers prolonged analgesia with less motor blockade, while bupivacaine, though potent, carries a higher cardiotoxicity risk. Dexamethasone, as an adjuvant, may further prolong analgesia by delaying systemic absorption and reducing inflammation. Data will be statistically analyzed to test the null hypothesis that dexamethasone addition yields no significant benefit over anesthetic alone. This study seeks to address the paucity of comparative evidence between ropivacaine–dexamethasone and bupivacaine–dexamethasone combinations in mandibular fracture surgery, potentially guiding clinicians toward optimal anesthetic protocols for improved patient outcomes, reduced analgesic consumption, and enhanced recovery. 
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