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CTRI Number  CTRI/2024/07/070893 [Registered on: 19/07/2024] Trial Registered Prospectively
Last Modified On: 05/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Regional versus General Anaesthesia- Which has better post-operative benefits following emergency fracture surgeries 
Scientific Title of Study   To assess the effect of type and incidence of morbidity on length of hospital stay between different anaesthesia technique following damage control orthopaedic surgery  
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.A.Swathy 
Designation  Junior Resident 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Department pf Anaesthesia, level 4, Nehru Hospital, PGIMER, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  7667867777  
Fax    
Email  swatheez@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.A.Swathy 
Designation  Junior Resident 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Department pf Anaesthesia, level 4, Nehru Hospital, PGIMER, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  7667867777  
Fax    
Email  swatheez@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr.Amarjyoti Hazarika 
Designation  Additional Professor 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Department pf Anaesthesia, level 4, Nehru Hospital, PGIMER, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9990238972  
Fax    
Email  amarjyoti28@rediffmail.com  
 
Source of Monetary or Material Support  
Department pf Anaesthesia, level 4, Nehru Hospital, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh, India, 160012 
 
Primary Sponsor  
Name  not applicable 
Address  not apploicable 
Type of Sponsor  Other [not applicable] 
 
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 
DrAmarjyoti Hazarika  Postgraduate Institute of Medical Education and Research  Department pf Anaesthesia, level 4, Nehru Hospital, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh, India, 160012
Chandigarh
CHANDIGARH 		 9990238972

amarjyoti28@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S829||Unspecified fracture of lower leg, (2) ICD-10 Condition: S799||Unspecified injury of hip and thigh,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  General Anaesthesia  The patient will be induced using Intravenous opioids (fentanyl 1-2mics/kg), Graded doses of intravenous anaesthetic drugs (propofol, etomidate) Neuromuscular blocking agent (atracurium 0.5mg/kg or vecuronium 0.1mg/kg) Anaesthesia will be maintained with inhalational agents either sevoflurane or isoflurane with air+ oxygen in 1:1 ratio, with fresh gas flows of 2L/min, securing airway with endotracheal tube of appropriate size in situ and maintaining a MAC in the range of 1-1.5. Intraoperative analgesia will be maintained with epidural infusion of 0.25% plain bupivacaine and postoperative analgesia will be maintained with infusion of plain bupivacaine 0.125% over a period of 72 hours. If further pain management is required, intravenous paracetamol 10-15mg/kg TDS or diclofenac 1mg/kg for breakthrough pain will be given.  
Comparator Agent  Regional Anaesthesia  Anaesthesia of the surgical site will be achieved using combined spinal epidural anaesthesia. Epidural catheters will be placed as already mentioned. Spinal anaesthesia will be administered using 26G Quinke’s needle in the same space as epidural catheter, with 2-3ml 0.5% heavy Bupivacaine + 25mcg fentanyl so as to achieve a spinal level of T10, which will be checked using hot and cold temperature sensation. Intraoperative analgesia will be maintained with epidural infusion of 0.25% plain bupivacaine and postoperative analgesia will be maintained with infusion of plain bupivacaine 0.125% over a period of 72 hours. If further pain management is required, intravenous paracetamol 10-15mg/kg TDS or diclofenac 1mg/kg for breakthrough pain will be given. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of ASA grade 1&2 between ages 18 to 60 years of either gender with open lower extremity fractures IIIa, and IIIb, of the one or both lower limbs being taken up for emergency surgery within 24 hours of injury and 12 hours of hospital admission. 
 
ExclusionCriteria 
Details  patients with uncontrolled comorbid conditions, upper limb fracture, hemodynamically unstable patients, vascular injury, pregnancy, pelvic thoracic and abdominal trauma, patient refusal 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the incidence and type of early morbidity between general versus regional anaesthesia technique assessed by POMS score at post-operative day (POD) 8 following emergency orthopaedic surgery  POD8 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the trends in POMS score between anaesthesia techniques on POD 1,3,5 and 8   POD 1,3,5 and 8  
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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 2 
Date of First Enrollment (India)   31/07/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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   This study is an RCT to compare the incidence and type of early morbidity between general versus regional anaesthesia technique assessed by POMS score at post-operative day (POD) 8 following emergency orthopaedic surgery that will be conducted in the Department of Anaesthesia & Intensive Care, PGIMER, Chandigarh in patients who had traumatic lower limb open fractures type IIIA and IIIB undergoing emergency orthopaedic surgery. Patients fulfilling the inclusion criteria will be recruited. Basic demographic data, ASA PS grade, Acute Physiology and Chronic Health Evaluation (APACHE) score, nature of injury, Injury Severity Score (ISS), site, duration and type of surgery, time since injury, co-morbidities, routine baseline investigations, including renal function test (RFT) and coagulation profile shall be recorded. Anaesthesia provider will not be blinded to the intervention. Patients will be randomly assigned to two groups in a 1:1 ratio using a computer-generated randomised list concealed by opaque sealed envelopes. The outcome assessor, data analyst will remain blinded. Postoperative morbidity will be measured by using Post Operative Morbidity Survey (POMS) score. For comparing POMS, each patient’s score will be recorded prospectively in the post-operative period at the following time points. T1- 1st Post operative Day (POD1), T2-POD3, T3-POD5, T4-POD8.


 
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