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CTRI Number  CTRI/2023/08/056737 [Registered on: 22/08/2023] Trial Registered Prospectively
Last Modified On: 25/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study intend to find out the efficacy of inserting epidural catheter using real time ultrasound over the conventional landmark technique in patients undergoing major abdominal surgeries 
Scientific Title of Study   The efficacy of real time ultrasound guided epidural catheter placement over conventional landmark technique in patients undergoing major abdominal surgeries - a prospective randomized Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arun Jagath A S 
Designation  Senior Resident 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH 
Address  Senior Resident, Department of Anesthesia, AIIMS RISHIKESH

Dehradun
UTTARANCHAL
249203
India 
Phone  9717828974  
Fax    
Email  jagath9717@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Arun Jagath A S 
Designation  Senior Resident 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH 
Address  Senior Resident, Department of Anesthesia, AIIMS RISHIKESH

Dehradun
UTTARANCHAL
249203
India 
Phone  9717828974  
Fax    
Email  jagath9717@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR PRAVEEN TALAWAR 
Designation  ADDL PROFESSOR 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES , RISHIKESH 
Address  DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE , AIIMS RISHIKESH
ADDL Professor, Department of Anaesthesia and Intensive Care, AIIMS Rishikesh , Uttarakhand 249203
Dehradun
UTTARANCHAL
249203
India 
Phone  9654162941  
Fax    
Email  praveenrt64@gmail.com  
 
Source of Monetary or Material Support  
AIIMS RISHIKESH 
 
Primary Sponsor  
Name  AIIMS RISHIKESH 
Address  AIIMS Rishikesh,Virbhadra road,Rishikesh Uttarakhand 249203 
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 Arun Jagath A S  AIIMS RISHIKESH  Department Of Anaesthesia AIIMS Rishikesh,Virbhadra road,Rishikesh Uttarakhand 249203
Dehradun
UTTARANCHAL 		 9717828974

jagath9717@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ALL INDIA INSTITUTE OF MEDICAL SCIENCES,RISHIKESH - INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Epidural catheter insertion using CLT  Thoracic epidural catheter inserted using conventional landmark technique 
Intervention  Epidural catheter insertion using Real time ultrasound.  In the intervention group, Thoracic epidural will be inserted using Real time ultrasound guidance. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA physical status I-III
Age group between 18-60 years
BMI < 30 Kg/m2
Patient posted for abdominal surgeries with anticipated midline or supraumbilical incision of length at least 5 cm
 
 
ExclusionCriteria 
Details  Patients with
Local infection at the epidural insertion site
Coagulopathy
Sepsis or septic shock
Obesity (BMI>30)
Allergy to local anaesthetics/opioids
Severe systemic disease ( ASA IV an d above)
Presence of spinal deformity
History of prior thoracic spine surgery
Laparoscopic surgeries
Any other absolute or relative contraindications for epidural catheter placement
Refusal to give consent
Inability to cooperate or understand the study protocol
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
First attempt Success rate   At the time of insertion of epidural catheter prior to surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of the following parameters in both group
1. Time for insertion
2. Time for preparation
3. Number of attempts
4. Change of Space
5. Number of needle redirection
6. Complications pertaining to epidural placement
a) Intravascular placement
b) Dural puncture
c) Catheter displacement
7. Post-operative back pain
8. Postoperative pain scores 4 hrly for 24 hours
9. Dosage of rescue analgesia given in 24 hours
10. Any other complications ( including nausea , vomiting , hypotension) in postoperative period
 		 Within 24 hours post operatively 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   31/08/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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 prospective, randomized clinical trial will be conducted in the Department of Anaesthesia and Intensive Care, AIIMS Rishikesh with the aim to compare the efficacy of real-time US-guided epidural catheter placement with the conventional landmark technique in patients undergoing major abdominal surgery.

The primary objective is to compare the first attempt success rate in a real-time ultrasound-guided epidural placement group with conventional landmark epidural catheter placement. In Group 1 32 patients receive epidural insertion using conventional landmark technique and 32 patients in Group 2 undergo real-time ultrasound-guided epidural insertion. The first pass success rate is compared in both the groups. All patients will be assessed till 24 hours. Post-operative pain relief, complication, incidence of back pain will also be compared in both the groups.

 
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