| CTRI Number |
CTRI/2025/09/094094 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing ultrasound and the traditional method to see which more precisely finds the epidural space depth in patients undergoing lower limb surgery in sitting versus lying position |
|
Scientific Title of Study
|
Comparing precision of ultrasonography assisted lumbar epidural space depth measurement against loss of resistance in sitting versus lateral position in lower limb surgeries - A randomised controlled trial |
| 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 Mansi Sharma |
| Designation |
Postgraduate trainee - 1 |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, 3rd floor OT Complex, Kalinga Institute of Medical Sciences and Pradyumna Bal Memorial Hospital, KIIT University, Patia, Bhubaneshwar
Khordha
ORISSA
751024
India |
| Phone |
7011676656 |
| Fax |
|
| Email |
mansi20398@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umesh Kumar Dash |
| Designation |
Professor |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, 3rd floor OT Complex, Kalinga Institute of Medical Sciences and Pradyumna Bal Memorial Hospital, KIIT University, Patia, Bhubaneshwar
Khordha
ORISSA
751024
India |
| Phone |
8779478574 |
| Fax |
|
| Email |
gasdoc2001@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjali Kumari |
| Designation |
Assistant Professor |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, 3rd floor OT Complex, Kalinga Institute of Medical Sciences and Pradyumna Bal Memorial Hospital, KIIT University, Patia, Bhubaneshwar
Khordha
ORISSA
751024
India |
| Phone |
9007474943 |
| Fax |
|
| Email |
drangi12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute of Medical Sciences(Infrastructure support),KIIT University, Patia, Khordha, Bhubaneswar, India Pin code - 751024
|
|
|
Primary Sponsor
|
| Name |
Kalinga Institute of Medical Sciences |
| Address |
KIMS hospital, KIIT university, KIIT Rd, Bhubaneswar- 751024, Odisha |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mansi Sharma |
Kalinga Institute of Medical Sciences |
Department of Anesthesiology, 3rd floor OT Complex, KIMS and Pradyumna Bal Memorial Hospital, KIIT Deemed to be University, Patia, Bhubaneswar
Khordha
ORISSA |
7011676656
mansi20398@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Kalinga Institute of Medical Sciences (IEC KIMS) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparing precision of ultrasonography assisted lumbar epidural space depth measurement against loss of resistance in sitting versus lateral position in lower limb surgeries. |
Group S (Sitting Posture): Patients will undergo epidural anesthesia in the sitting posture during the intra-operative period. |
| Comparator Agent |
Comparing precision of ultrasonography assisted lumbar epidural space depth measurement against loss of resistance in sitting versus lateral position in lower limb surgeries. |
Group L (Lateral Posture): Patients will undergo epidural anesthesia in the lateral posture during the intra-operative period. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex of age 18-80
2. Patients under American Society of Anesthesiology (ASA) grade I-III.
3. Patients scheduled for lower limb surgeries under epidural anesthesia.
|
|
| ExclusionCriteria |
| Details |
1. Informed refusal by the patient
2. Infection at the Injection Site
3. Uncorrected hypovolemia or shock leading to profound hypo tension following sympathetic blockade.
4. Severe coagulopathy or anticoagulation which includes :
-INR greater than 1.4
-Platelet count less than 80,000/micro liter
-Recent use of heparin, warfarin, NOACs (e.g., apixaban, rivaroxaban)
5. Raised intracranial pressure (especially with mass lesion)
6. Allergy to local anesthetics or adjuvants.
7. Severe spinal deformities.
8. Progressive neurological diseases.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in precision of depth of epidural space measured by USG-assisted and loss of resistance methods in sitting versus lateral position. |
Depth of epidural space measured by USG-assistance assessed at baseline and by loss of resistance in sitting or lateral position assessed within 15 minutes of patient in-time (intra-operatively). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/09/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Central neuraxial block ( CNB ) is a widely used regional anesthesia technique, achieved by injecting local anesthetics into the sub arachnoid or epidural space to block spinal nerve roots. Traditionally, CNB relies on anatomical landmarks and the loss of resistance (LOR) technique, but this gold standard technique ia a blind approach which often requires multiple attempts, increasing complications.Ultrasonography (USG) has emerged as a valuable tool which is safe, non-invasive and provides real time image for visualizing spinal anatomy, improving first-pass success rates, and reducing needle redirection.This prospective, randomized, single-blind study aims to compare the precision of USG-assisted epidural space depth measurement against the LOR technique in sitting versus lateral position during lower limb surgeries and the study will help evaluate whether patient positioning affects the precision of epidural depth measurement and also to enhance the safety and accuracy of CNB in clinical practice. |