| CTRI Number |
CTRI/2025/08/093696 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
24/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of limb pressure determined by ultrasound doppler versus the conventional technique for lower limb surgeries under tourniquet. |
|
Scientific Title of Study
|
Comparison of limb occlusion pressure determined by ultrasound doppler versus the conventional technique for lower limb surgeries under tourniquet: A Randomized controlled 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 |
Garima Singh |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room number 413, BL Taneja Block, Department of Anesthesiology, 4th floor, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
8130807306 |
| Fax |
|
| Email |
garimasingh1725@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rahil Singh |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room number 413, BL Taneja Block, Department of Anesthesiology, 4th floor, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9810719025 |
| Fax |
|
| Email |
drrahilsingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Garima Singh |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room number 413, BL Taneja Block, Department of Anesthesiology, 4th floor, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
8130807306 |
| Fax |
|
| Email |
garimasingh1725@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lok Nayak Hospital, Jawaharlal Nehru Marg, near Delhi Gate, New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi,110002 |
| Type of Sponsor |
Government 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 Garima Singh |
Lok Nayak Hospital |
OT2,2nd floor, New Operation Theatre Block, Department Of Anesthesiology
Central
DELHI |
8130807306
garimasingh1725@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College and Associated Hospitals, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group SG (Standard Group) |
Limb occlusion pressure is set according to the pre-operative systolic blood pressure |
| Intervention |
Group UG (Ultrasound group) |
Limb occlusion pressure is determined using the ultrasound doppler pre-operatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 to 70 years with American Society of Anesthesiologists (ASA) physical status I to III |
|
| ExclusionCriteria |
| Details |
Peripheral vascular conditions including varicose veins and arterial occlusive vasculitis, History of deep vein thrombosis in last 3 months, Hematological disorders such as sickle cell anemia and Patients taking Antiplatelet drugs preoperatively. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean limb occlusion pressure to achieve a hemostasis score of less than 4 |
Pre operatively measured i.e. Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intraoperative hemostasis score |
|
| Tourniquet related complications |
6,12,24,48 hours after surgery |
| Limb circumference measurement |
24 and 48 hours after surgery |
| Surgeons satisfaction score |
24 hours post operatively |
| Quality of recovery |
48 hours post operative |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
04/09/2025 |
| 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="1"
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
|
Double blind, Randomized controlled study of 38 patients undergoing tourniquet assisted lower limb surgeries under central neuraxial block. This study compares the 2 groups for limb occlusion pressure. Group UG determines limb occlusion pressure by using ultrasound doppler and Group SG in which limb occlusion pressure is set according to the preoperative systolic blood pressure. Primary outcome is the mean limb occlusion pressure to achieve hemostasis score of less than 4. Secondary outcomes are Intraoperative hemostasis score, Tourniquet related complications at 6, 12, 24, 48 hours, Limb circumference measurement at 24 hours and 48 hours., Surgeon’s satisfaction score at 24 hours post operatively and Quality of recovery at 48 hours post operatively. |