| CTRI Number |
CTRI/2024/09/073708 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
30/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia
Screening
Process of Care Changes
Other (Specify) [Technique] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study between real-time ultrasound guided and ultrasound-assisted techniques for spinal anesthesia for patients undergoing lower-limb orthopaedic surgeries. |
|
Scientific Title of Study
|
Real-Time Ultrasound–Guided Versus
Ultrasound-Assisted Spinal Anesthesia in
patients undergoing lower limb
orthopaedic Surgery. A prospective,
randomized, single-blind, comparative
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 |
Neha Hatkar |
| Designation |
Post-graduate student |
| Affiliation |
HBTMC AND DR R.N.COOPER HOSPITAL, VILE PARLE WEST, 400056 |
| Address |
Department of Anaesthesiology, HBT Medical College and Dr. R.N.Cooper Municipal General Hospital, Vile Parle West
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
7738809923 |
| Fax |
|
| Email |
neha.hatkar@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anita Shetty |
| Designation |
Professor and Head of Department |
| Affiliation |
HBTMC AND DR R.N.COOPER HOSPITAL, VILE PARLE WEST, 400056 |
| Address |
Department of Anaesthesiology,
HBT Medical College and Dr. R.N.Cooper Municipal General Hospital, Vile Parle West
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
9223434852 |
| Fax |
|
| Email |
anitanshetty@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Neha Hatkar |
| Designation |
Post-graduate student |
| Affiliation |
HBTMC AND DR R.N.COOPER HOSPITAL, VILE PARLE WEST, 400056 |
| Address |
Department of Anaesthesiology, HBT Medical College and Dr. R.N.Cooper Municipal General Hospital, Vile Parle West
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
7738809923 |
| Fax |
|
| Email |
neha.hatkar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| HBT Medical College and Dr.R.N.Cooper Municipal General Hospital, Vile Parle West , 400056 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| NEHA HATKAR |
HBT MEDICAL COLLEGE AND DR R N COOPER HOSPITAL, VILE PARLE WEST |
ORTHOPAEDIC OPERATION THEATER, 3rd floor, F-wing
Mumbai (Suburban)
MAHARASHTRA |
7738809923
neha.hatkar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE HBT MEDIVAL COLLEGE AND DR R N COOPER MUNICIPAL GENERAL HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M80||Osteoporosis with current pathological fracture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Real-time ultrasound guided spinal anaesthesia |
after marking widest intervertebral space similar to ultasound-assisted technique, the curvilinear probe is held in non-dominant hand and spinal needle in dominant hand. the probe is placed vertically paramedian at the intersection point and the needle is advanced under vision till dural penetration is achieved in Paramedian Saggital Out-of Plane approach. On ana average, 1-2 cases performed daily over a period of 6 months. |
| Intervention |
Ultrasound-assisted spinal anaesthesia |
Patient is given sitting position, prepared for spinal anaesthesia. Curvilinear probe of portable ultrasound machine is used to locate the widest intervertebral space and marked with sterile skin marker. Spinal anaesthesia is given at the intersection point.
On an average 1-2 cases performed daily over a period of 6 months, |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled for lower limb orthopaedic surgeries with spinal anaesthesia
18 to 70 years of age.
ASA I to III
|
|
| ExclusionCriteria |
| Details |
Patients with severe cardiopulmonary diseases.
Patients with contraindications of spinal anaesthesia.
Patients unwilling to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the first attempt success rate of Ultrasound-assisted versus Real-time ultrasound guided spinal anaesthesia
techniques in patients undergoing lower limb orthopaedic surgeries. |
Parameters will be assessed at baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the first-pass success rate,number of attempts, number of passes, procedure time, &
complications in Ultrasound-assisted versus Real-time ultarsound guided spinal anaesthesia techniques.
To analyze the above parameters in subgroups of the study groups according to
age, sex, BMI, & lumbar spine deformity. |
Parameters noted at Baseline.
|
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/09/2024 |
| 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)
|
Not Applicable |
| 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
|
Spinal anaesthesia is traditionally performed using the landmark technique. Despite the spinous processes being reliable surface anatomical landmarks in many patients, they are not always easily recognized. Multiple needle attempts may lead to a higher incidence of complications. Ultrasonography scanning has shown better puncture success rates, shorten puncture time and greater efficacy and safety of spinal anaesthesia. Techniques such as Ultrasound assisted (USAS) and Real-time guided ultrasound (USRTG) can be used to facilitate the same. |