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CTRI Number  CTRI/2017/07/009137 [Registered on: 27/07/2017] Trial Registered Retrospectively
Last Modified On: 06/02/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Other (Specify) [Preprocedural use of ultrasound for Epidural catheterisation in group "B" ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   “Comparison of standard blind technique with preprocedural use of ultrasound for Epidural component of Combined Spinal Epidural Block in patients undergoing joint replacement surgeries" 
Scientific Title of Study   “A study to compare the use of ultrasound and conventional blind technique for Epidural neuraxial blockade in orthopaedic joint replacement surgeries : A randomised control trial”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
USG0JRG2016 VERSION 2.0 dated 17 June 2017  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kompal Jain 
Designation  secondary DNB 
Affiliation  Max Super Speciality Hospital, A unit of Balaji Medical and Diagnostic Research Centre 
Address  Anaesthesia department, OT complex,2nd floor, new building(PPG2),Max Super Speciality Hospital, 108A Indraprastha Extension, Patparganj, New Delhi

New Delhi
DELHI
110092
India 
Phone  8289037336  
Fax    
Email  kompaljain3.kj@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vikky Jaiswal coguide  
Designation  Consultant, Anaesthesia and Pain management 
Affiliation  Max super Speciality Hospital, A unit of Balaji Medical and Diagnostic Research Centre 
Address  Anaesthesia department, OT complex,2nd floor, new building(PPG2),Max Super Speciality Hospital, 108A Indraprastha Extension, Patparganj, New Delhi

New Delhi
DELHI
110092
India 
Phone  9582265897  
Fax    
Email  vikkyjaiswal34@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arun Puri Guide 
Designation  Director, Head of Department, Anaesthesia and Pain management 
Affiliation  Max Super Speciality Hospital, A unit of Balaji Medical and Diagnostic Research Centre 
Address  Anaesthesia department, OT complex,2nd floor, new building (PPG2), Max SuperSpeciality Hospital, 108A Indraprastha Extension, Patparganj , New Delhi - 110092

New Delhi
DELHI
110092
India 
Phone  9811074379  
Fax    
Email  arun.puri@maxhealthcare.com  
 
Source of Monetary or Material Support  
Anaesthesia department, OT complex,2nd floor, new building(PPG2),Max Super Speciality Hospital, 108A Indraprastha Extension, Patparganj, New Delhi-110092 
 
Primary Sponsor  
Name  Max Super Speciality hospital 
Address  Anaesthesia department, OT complex,2nd floor, new building(PPG2),Max Super Speciality Hospital, 108A Indraprastha Extension, Patparganj, New Delhi 
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 Kompal Jain DNB Dr Arun PuriGuide  Max Super Speciality Hospital, A unit of Medical and Diagnostic Research Centre   Anaesthesia department, OT complex,2nd floor, new building(PPG2),108A,Indraprastha Extension, Patparganj, New Delhi-110092
New Delhi
DELHI 		 8289037336

kompaljain3.kj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee and Dr Ribhu Rajpal as member Secretary  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  ASA l-lll patients with age more than 50 years , BMIequal to / more than 30 kg/m2 posted for joint replacement surgeries under combined spinal epidural anaesthesia, (1) ICD-10 Condition: M16||Osteoarthritis of hip, (2) ICD-10 Condition: M17||Osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Blind conventional technique of inserting epidural catheter  In group"A", level of intervertebral space was identified by Tuffiers line and needle insertion point identified by palpation.Epidural Depth confirmed by Loss of Resistance Technique  
Intervention  Preprocedural use of ultrasound  In group "B" preprocedural use of ultrasound for identifying level of intervertebral space,needle insertion site and Epidural Depth was done. Epidural depth was also confirmed by Loss of Resistance technique 
 
Inclusion Criteria  
Age From  51.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Patients undergoing orthopaedic joint replacement surgeries

2. Patients with age more than 50 years

3. ASA I-III patients

4. Patients able to provide own consent

5. Patients with BMI ≥ 30 kg/m2
 
 
ExclusionCriteria 
Details  1. ASA IV - V patients

2. Patients with known hypersensitivity to local anaesthetics

3. Patients with bleeding disorders

4. Patients on anticoagulants

5. Patients with infection at neuraxial blockade site

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Rate of successful epidural block on the first needle insertion attempt in both groups with blind conventional technique and preprocedural use of ultrasound  zero seconds /minutes or few seconds after local infilteration  
 
Secondary Outcome  
Outcome  TimePoints 
Number of needle insertion attempts required for successful epidural block
A needle insertion attempt was defined as needle insertion preceded by complete withdrawal of the Tuohy‟s needle from the patient‟s skin. 		 zero sec/min
few seconds after local infilteration 
Number of needle passes (insertion and redirection attempts) required for successful epidural block
A needle redirection attempt was defined as any change in needle insertion trajectory that did not involve complete withdrawal of the needle from the patient‟s skin.

A needle pass was defined either as needle insertion or redirection attempt.

 		 Zero seconds/minutes or few seconds after local infilteration 
Correlation of depth of the epidural space measured with an Ultrasound and LOR technique.  zero seconds / minutes or few seconds after local infilteration 
Number of Accidental Dural Puncture by Tuohys needle of Combined Spinal Epidural set  at Zero second /minutes or few seconds after local infilteration 
The efficacy of the epidural component of combined spinal epidural anaesthesia  determined by pain relief (VAS) after 30 minutes of initiation of epidural infusion postoperatively after return of toe movements and patient satisfaction after 5 hours of epidural catheter insertion.These were the end points of the study. 
Number of failed block
A failed epidural was defined as a block providing inadequate analgesia (VAS ≥ 4/10) despite the following sequential steps:
10 ml bolus of 0.5% Bupivacaine ,Second dose of 10 ml bolus of 0.5% Bupivacaine and third 5mL 2% Lidocaine bolus
 		 10,20 and 30 minutes of initiation of epidural infusion postoperatively and 3.5, 4,4.5 and 5 hours from insertion of epidural catheter
In case of failed block, reassessment every 15 minutes 
Visual Analog Scale   10.20 and 30 minutes after initiation of Epidural Infusion postoperatively  
Patient Satisfaction Score  3.5,4,4.5 and 5 hours after insertion of epidural catheter 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
Final Enrollment numbers achieved (Total)= "210"
Final Enrollment numbers achieved (India)="210" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/08/2016 
Date of Study Completion (India) 09/03/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="7"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
Aging is of course a biological reality. As population ages, degenerative joint diseases limit the physical activity, hampering their independence and quality of life. Due to increasing life expectancy, sedentary lifestyle, obesity and with advancement in health care infrastructure and technology, joint replacement surgeries are on the rising trend to improve the quality of life. Since decades, anaesthesiologists have striven to perfect identification and cannulation of epidural space using skills learned i.e. knowledge of relevant anatomy and detection of tactile clues during training and early clinical practice.
 Patients undergoing joint replacement surgeries increase the challenge for epidural anaesthesia as they are mostly above 50 years of age, having arthritic joints with osteophytic spine, calcified spinal ligaments and narrowed intervertebral spaces. These are mostly obese patients with difficult palpation of anatomical landmarks of spine and spine deformities due to increasing age and gait changes. The positioning for neuraxial blockade is also difficult and suboptimal in these patients as they have lesser compliance and decreased ability to flex the spine.Multiple attempts and difficult access to epidural space is a frequent problem in operating theaters with the standard blind approach in these obese patients with osteophytic spines undergoing joint replacement surgeries. The technical complexities of the epidural catheter insertion can be hazardous for the patient as it increases the risk of procedural complications like accidental dural puncture , failed block and patient discomfort.
The endeavour of this study was to assess the utility of the preprocedural use of an ultrasound technology compared with the conventional blind technique for the epidural catheterisation in obese patients with osteophytic spines undergoing joint replacement surgeries in identifying the correct vertebral space, point of insertion of the epidural needle, depth of the epidural space and its accuracy with respect to success rate of epidural catheterisation in the first attempt vis a vis the blind approach.
 
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