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CTRI Number  CTRI/2024/07/070170 [Registered on: 08/07/2024] Trial Registered Prospectively
Last Modified On: 09/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Lumbar epidural procedure and ultrasound: Predictive factors 
Scientific Title of Study   Measurement of Inter-Laminar space using ultrasound for the prediction of ease of lumbar epidural procedure : A cross sectional 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  Rithu Rachel George  
Designation  Junior resident 
Affiliation  Sakra world hospital  
Address  Department of Anaesthesiology, OT complex, 2ND floor, Sakra World Hospital, Devarabeesanahalli, outer ring road, Marathahalli, Bengaluru, Karnataka.

Bangalore
KARNATAKA
560103
India 
Phone  7736438759  
Fax    
Email  rithugeorge2010@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dhananjay DN 
Designation  Senior Consultant 
Affiliation  Sakra world hospital 
Address  2ND floor, OT complex, Department of Anaesthesiology, Sakra world hospital, Devarabeesanahalli, Outer ring road, Marathahalli Bengaluru Karnataka.

Bangalore
KARNATAKA
560103
India 
Phone  8073687393  
Fax    
Email  dhananjaydn@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Dhananjay DN 
Designation  Senior Consultant 
Affiliation  Sakra world hospital 
Address  Department of Anaesthesiology, OT complex, 2ND floor, Sakra World Hospital, Devarabeesanahalli, Outer ring road, Marathahalli, Bengaluru, Karnataka.

Bangalore
KARNATAKA
560103
India 
Phone  8073687393  
Fax    
Email  dhananjaydn@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, OT complex, 2ND floor, Sakra World Hospital, Devarabeesanahalli, outer ring road, Marathahalli, Bengaluru, Karnataka, India,560103 
 
Primary Sponsor  
Name  Dr Rithu Rachel George 
Address  Department of Anaesthesiology, OT complex, 2ND floo, Sakra World Hospital, Devarabeesanahalli, outer ring road, Marathahalli, Bengaluru, Karnataka, India, 560103 
Type of Sponsor  Other [Self] 
 
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 Dhananjay DN  Sakra World Hospital  Department of Anaesthesiology, OT complex, 2ND floo, Sakra World Hospital, Devarabeesanahalli, outer ring road, Marathahalli, Bengaluru, Karnataka, India, 560103
Bangalore
KARNATAKA 
08073687393

dhananjaydn@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sakra World Hospital Institutional Ethics Committee  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 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients undergoing lumbar epidural/combined spinal epidural procedure. 
 
ExclusionCriteria 
Details  Patients who deny informed consent
Patients with history of lumbar spine surgery
Allergy to local anaesthetics
Coagulation abnormalities
Suspected infection at local site
Ankylosing spondylitis
Emergency surgeries
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To assess the correlation of interlaminar distance measured using ULTRASONOGRAPHY in predicting the ease of epidural space identification and success of epidural catheterization in lumbar space   Immediately after insertion of epidural catheter. Baseline and endpoint time is 0  
 
Secondary Outcome  
Outcome  TimePoints 
1.Number of passes.
2.Assessment of patient’s comfort during epidural procedure.
3.Assessment of pain scores during the procedure.
4.Incidence of adverse events.
 
1.Number of passes - during the procedure.
2.Other outcomes - immediately after the insertion of epidural catheter.
 
 
Target Sample Size   Total Sample Size="224"
Sample Size from India="224" 
Final Enrollment numbers achieved (Total)= "225"
Final Enrollment numbers achieved (India)="225" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/07/2024 
Date of Study Completion (India) 28/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Epidural anaesthesia is anaesthesia obtained by blocking spinal nerves in the epidural space as the nerves emerge from the dura and then pass into the intervertebral foramina. In 1885, corning performed first epidural anaesthesia with cocaine for relief of pain in an extremity, it was apparently accidental.

In 1895, cathelin used epidural anaesthesia in sacral region which is now called as caudal analgesia. In 1921, F. Pages performed epidural anaesthesia in his surgical practice. In 1949, Curbelo first performed continuous epidural anaesthesia by means of ureteral catheter.

Epidural anaesthesia is used to provide effective intraoperative and post operative analgesia. A segmental block is produced chiefly of spinal sensory and sympathetic nerve fibers. Motor fibers may be partially blocked.

Standard epidural catheterization techniques namely the loss of resistance and saline drop methods rely on palpation of surface anatomy and the experience of the anaesthesiologist.

Ultrasound assisted CSE anaesthesia technique provides improved precision and efficacy,overcoming the technical difficulties of performing neuraxial blocks.

In 2001,Grau et all reported that preprocedure ultrasonography reduced the number of puncture attempts needed to establish epidural analgesia in women with risk factors for difficult neuraxial block insertion.There is significant evidence supporting the role of neuraxial ultrasound in improving the precision and efficacy of neuraxial anesthetic techniques.

Multiple CNB attempts in difficult epidural procedures increase morbidities such as trauma, pain, higher incidence of post-dural puncture headache, paresthesia, spinal hematoma and failure. A five point score was created to predict DEP but there is no evidence of USG based parameter for prediction of ease of epidural procedures. The working space for the epidural procedure between two adjacent vertebrae can be divided into the interspinous and interlaminar spaces. The interlaminar space is bounded by the bases of the spinous processes, laminae, inferior articular processes, and superior articular processes. Interlaminar space can be identified and measured easily using USG due to its anatomical advantage.Information regarding USG assisted epidural insertion using interlaminar space measurement for prediction of ease of epidural procedure is minimal/nil in literature. Hence, we propose to measure the interlaminar distance using USG to find its correlation with ease of epidural.

 
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