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CTRI Number  CTRI/2025/10/096316 [Registered on: 22/10/2025] Trial Registered Prospectively
Last Modified On: 18/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Faster recovery after surgery in face injury 
Scientific Title of Study   ERAS pathway in maxillofacial trauma: A prospective randomised comparison with conventional 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  Vidyashree G S 
Designation  Junior Resident 
Affiliation  Post Graduate Institute Of Medical Education and Research 
Address  Department of Anaesthesia and Intensive Care, PGIMER, Chandigarh,

Chandigarh
CHANDIGARH
160012
India 
Phone  9113606482  
Fax    
Email  vidyashreegs12@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nidhi Bhatia 
Designation  Professor 
Affiliation  Post Graduate Institute Of Medical Education and Research 
Address  Department of Anaesthesia and Intensive Care, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9914207483  
Fax    
Email  nidhi.bhatia75@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nidhi Bhatia 
Designation  Professor 
Affiliation  Post Graduate Institute Of Medical Education and Research 
Address  Department of Anaesthesia and Intensive Care, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9914207483  
Fax    
Email  nidhi.bhatia75@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Department of Anaesthesia and Intensive care  
Address  PostGraduate Institute of Medical Education and Research, Sector 12, Chandigarh, 160012  
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 
Dr Nidhi Bhatia  PostGraduate Institute of Medical Education and Research  Department of Anesthesia and Intensive Care, Level IV, Nehru Hospital, Sector 12,Chandigarh,160012
Chandigarh
CHANDIGARH 		 9914207483

nidhi.bhatia75@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Intramural)  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional care  Patient management will be done according to existing standard of care 
Intervention  ERAS   patient management will be done according to Enhanced Recovery After Surgery (ERAS) protocol 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  diagnosed with maxillofacial injuries requiring surgical fixation under general anaesthesia 
 
ExclusionCriteria 
Details  Head injuries
Polytrauma
Scheduled for multiple surgeries
A diagnosed Psychiatric illness
Already intubated or tracheostomised
Refusal to provide consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Length of hospital stay  at the time of discharge 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of Recovery using QoR-15 scale   24 hours postoperatively, 48 hours postoperatively, at discharge
 
Patient satisfaction at discharge using 5 level likert scale  at discharge 
Perioperative opioid use   From day of admission to day of discharge 
Compications, if any, including airway obstruction, aspiration, difficult intubation/extubation, intraoperative bleeding, local anaesthesia toxicity, postoperative infection, surgical hardware failure or instability.  from day of admission to day of discahrge 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   N/A 
Date of First Enrollment (India)   01/11/2025 
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="0"
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   ERAS pathways are patient centred, evidence based protocols involving multidisciplinary team replacing traditional practices of patient management and thereby enhance patient recovery and reduce number of days spent in the hospital. There are ERAS protocols for surgeries across various specialties but none for maxillofacial trauma. hence, this study is designed with the aim of formulating ERAS protocol for patients with maxillofacial injuries.  
The methodology involves randomising patients with maxillofacial trauma meeting inclusion and exclusion criteria into two groups. One group receives the conventional care while the other group receives treatment according to the ERAS pathway formulated by us based on ERAS consensus guidelines for colorectal surgery. Length of hospital stay are compared along with other outcomes such as quality of recovery, perioperative opioid use, patient satisfaction and any complications between both the groups.


 
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