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CTRI Number  CTRI/2021/03/032333 [Registered on: 26/03/2021] Trial Registered Prospectively
Last Modified On: 16/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Other (Specify) [ULTRASOUND USE IN EPIDURAL]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   COMPARING SUCCES RATE AND ADVERSE EVENTS BETWEEN EPIDURAL ANAESTHESIA TECHNIQUE USING ULTRASOUND SCANNING AND CONVENTIONAL TECHNIQUE OF ANATOMICAL LANDMARK IN KNEE REPLACEMENT SURGERY PATIENTS 
Scientific Title of Study   COMPARISON OF EASE OF PROCEDURE AND SUCCESS RATE IN LUMBAR EPIDURAL ANAESTHESIA USING PRE- PROCEDURAL ULTRASOUND MARKING AND MANUAL PALPATION TECHNIQUE IN KNEE ARTHROPLASTY PATIENTS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ANOOP SEBASTIAN 
Designation  DNB RESIDENT 
Affiliation  SAKRA WORLD HOSPITAL 
Address  DNB RESIDENT ANAESTHESIA SAKRA WORLD HOSPITAL BANGALORE

Bangalore
KARNATAKA
560103
India 
Phone  8606670866  
Fax    
Email  sebastian.anoop@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DHANANJAY D N  
Designation  SENIOR CONSULTANT 
Affiliation  SAKRA WORLD HOSPITAL 
Address  SENIOR CONSULTANT ANAESTHESIA SAKRA WORLD HOSPITAL BANGALORE

Bangalore
KARNATAKA
560103
India 
Phone  8073687393  
Fax    
Email  dhananjaydn@gmail.com  
 
Details of Contact Person
Public Query
 
Name  ANOOP SEBASTIAN 
Designation  DNB RESIDENT 
Affiliation  SAKRA WORLD HOSPITAL 
Address  DNB RESIDENT ANAESTHESIA SAKRA WORLD HOSPITAL BANGALORE


KARNATAKA
560103
India 
Phone  8606670866  
Fax    
Email  sebastian.anoop@gmail.com  
 
Source of Monetary or Material Support  
SAKRA WORLD HOSPITAL BANGALORE 
 
Primary Sponsor  
Name  SAKRA WORLD HOSPITAL 
Address  SAKRA WORLD HOSPITAL BANGALORE 
Type of Sponsor  Private hospital/clinic 
 
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 ANOOP SEBASTIAN  SAKRA WORLD HOSPITAL  DEVARABEESANAHALLI VARTHUR HOBLI BANGALORE
Bangalore
KARNATAKA 
8606670866

sebastian.anoop@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  TRADITIONAL MANUAL PALPATION TECHNIQUE  NIL 
Intervention  USE OF ULTRASOUND  ULTRASOUND TO IDENTIFY EPIDURAL SPACE AND COMPARED WITH TRADITIONAL MANUAL ALPATION TECHNIQUE FOR EPIDURAL ANAESTHESIA 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Adult’s patients of ASA 1 and 2 between 50-70 years coming for knee arthroplasty 
 
ExclusionCriteria 
Details  1. No consent from the patient’s caregiver/ patients or attender’s refusal.
2. Lower limb Neuropathy in preoperative evaluation.
3. History of lower back pain.
4. Coagulation disorders
5. Hemodynamic instability in perioperative period.
6. Previous history of spine surgeries
7. History of post-Dural puncture headaches.
8. Allergy to local anaesthesia drugs (Lignocaine and Bupivacaine). 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) Ease of epidural insertion as assessed by

 
after epidural cathetrisation 
 
Secondary Outcome  
Outcome  TimePoints 
1. Comparison of pre-procedural epidural length determined by ultrasound with actual length identified by loss of resistance technique.
2. Comparison of comfort level felt by patient during epidural catheterization procedure.
3. Comparison of average Length of epidural space in males and females in Indian population.
4. Incidence of adverse events. 
after completion of epidural cathetrisation  
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="96" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/04/2021 
Date of Study Completion (India) 16/07/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Combined spinal epidural anaesthesia is the preferred choice for anaesthesia in knee arthroplasty patients. Lumbar neuraxial procedures are typically performed via a blind surface landmark and palpation technique. The success depends on good knowledge of anatomy and skills due to its complexity. Patient factors such as obesity, abnormal spinal anatomy or previous spine surgeries result in increased failure rate of neuraxial blockade. The intercristal line/ Tuffiers line determined by palpation may not be a reliable landmark for fourth and fifth lumbar interspace in neuraxial anaesthesia. Lumbar spinous process increases significantly in both length and width with ageing, which makes epidural anaesthesia technique challenging through midline in geriatric population in whom majority of knee replacement surgeries are done. Neuraxial ultrasonography in epidural space identification is a recent development and has shown to improve the success rate of neuraxial blockade and can reduce the risk of failed or traumatic lumbar punctures and epidural catheterizations. The use of preprocedural ultrasound has been shown to increase first pass success rate in thoracic epidural catheter insertion and spinal anaesthesia in patients with difficult surface landmarks. Therefore, this prospective, randomised study has been designed to assess the ease of insertion and its success rate after identification of the relevant landmarks using ultrasound as compared to traditional palpation of bony landmarks.

 
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