| CTRI Number |
CTRI/2025/09/094014 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
30/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing the effect of injecting medicine in the subcutaneous tissue that blocks the sensation with the injecting medicine around the nerve that blocks the sensation area supplied by it in case of hand surgery |
|
Scientific Title of Study
|
A study comparing Wide awake local anaesthesia with no tourniquet (WALANT) with Upper limb nerve block for hand surgeries |
| 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 Sarita Kumari Chauhan |
| Designation |
Junior Resident |
| Affiliation |
ESIC BASAIDARAPUR NEW DELHI |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, 3RD FLOOR OT ROOM 2 , ESIC BASAIDARAPUR NEW DELHI 91
West
DELHI
110091
India |
| Phone |
8219569834 |
| Fax |
|
| Email |
saritakumarichauhan1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Sethi |
| Designation |
PROFESSOR |
| Affiliation |
|
| Address |
DEPARTMENT OF ANAESTHESIOLOGY 3RD FLOOR ROOM 2 ESIC PGIMSR BASAIDARPUR NEW DELHI 110015
West
DELHI
110015
India |
| Phone |
9891230700 |
| Fax |
|
| Email |
divyasth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Sethi |
| Designation |
PROFESSOR |
| Affiliation |
|
| Address |
DEPARTMENT OF ANAESTHESIOLOGY , 3ED FLLOR OT ROOM 2, ESIC PGIMSR BASAIDARPUR NEW DELHI 110015
West
DELHI
110015
India |
| Phone |
9891230700 |
| Fax |
|
| Email |
divyasth@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC PGIMSR BASAIDARAPUR NEW DELHI
PIN-110015
INDIA |
|
|
Primary Sponsor
|
| Name |
Dr sarita chauhan |
| Address |
INSTITUTE- ESIC PGIMSR BASAIDARAPUR NEW DELHI-110015, INDIA
|
| Type of Sponsor |
Other [SELF] |
|
|
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 SARITA KUMARI CHAUHAN |
ESIC PGIMSR BASAIDARAPUR |
ESIC PGIMSR BASAIDARAPUR NEW DELHI 1100015, DEPARTMENT OF ANAESTHESIOLOGY , 3RD FLOOR ROOM NO 2
West
DELHI |
8219569834
saritakumarichauhan1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC PGIMSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: W230||Caught, crushed, jammed, or pinched between moving objects, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NERVE BLOCK |
LOCAL ANAESTHESIA WITH NO TOURNIQUET AND UPPER LIMB NERVE BLOC |
| Comparator Agent |
Nerve block |
UPPER LIMB NERVE BLOCK |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
DURATION OF SURFGERIES LESS THAN 1 HOUR |
|
| ExclusionCriteria |
| Details |
Allergic to anaesthetic drug, injection at site of injection, coagulation disorder , Patient on Anticoagulation, psychiatric illness, neurological deficit , Raynaud’s disease , Scleroderma |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean intra operative vas score |
At the interval of 5,10,15,30,45 mins and 1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluate the difference between - Preparation time, patient satisfaction score, surgeon satisfaction score , need for rescue analgesic, need for conversion into GA, post operative VAS score, first post operative analgesic request time |
At the interval of 5,10,15,30,45,minutes & 1 hour both intra operative period & post operative period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
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="1"
Months="6"
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
|
It is a study comparing Wide awake local anaesthesia with Upper limb nerve block for hand surgeries. WALANT anaesthesia ( lidocaine+ epinephrine) injected directly at the surgical site without tourniquet and sedation, no tourniquet removes the patient discomfort and epinephrine use minimises blood loss. it can be done in minor procedure room and requires less preparation time it is cost effective. Upper limb nerve block is a regional anaesthesia technique where anaesthetic drug is injected nerve the nerve plexus to anaesthetise a larger field using ultrasound machine. it may require tourniquet to minimise the bleeding. patient may be awake or sedated, complication risk are higher. |