| CTRI Number |
CTRI/2026/04/107623 [Registered on: 06/04/2026] Trial Registered Prospectively |
| Last Modified On: |
29/03/2026 |
| 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
|
Comparison of two ultrasound-guided nerve block techniques for hand,wrist and forearm surgery. |
|
Scientific Title of Study
|
A comparison between axillary brachial plexus block and peripheral nerve block of five nerves around the elbow using ultrasound in patients undergoing surgeries of the wrist, hand and distal forearm : a randomised single-blind 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 |
Himanshi Saini |
| Designation |
DNB Trainee |
| Affiliation |
Tata Main Hospital |
| Address |
Department of Anaesthesia, Main Operation Theatre, Tata Main Hospital, C Road(West), Northern Town, Bistupur, Jamshedpur, Kolhan division.
Purbi Singhbhum
JHARKHAND
831001
India |
| Phone |
9029041778 |
| Fax |
|
| Email |
himanshi06saini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Himanshi Saini |
| Designation |
DNB Trainee |
| Affiliation |
Tata Main Hospital |
| Address |
Department of Anaesthesia, Main Operation Theatre, Tata Main Hospital, C Road(West), Northern Town, Bistupur, Jamshedpur, Kolhan division.
Purbi Singhbhum
JHARKHAND
831001
India |
| Phone |
9029041778 |
| Fax |
|
| Email |
himanshi06saini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Himanshi Saini |
| Designation |
DNB Trainee |
| Affiliation |
Tata Main Hospital |
| Address |
Department of Anaesthesia, Main Operation Theatre,Tata Main Hospital, C Road(West), Northern Town, Bistupur, Jamshedpur, Kolhan division.
Purbi Singhbhum
JHARKHAND
831001
India |
| Phone |
9029041778 |
| Fax |
|
| Email |
himanshi06saini@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Srividhya |
| Address |
Department of Anaesthesia, Main Operation Theatre,Tata Main Hospital, C Road(West),Northern Town,Bistupur, Jamshedpur-831001, Kolhan division, Jharkhand, India. |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Himanshi Saini |
Tata Main Hospital |
Department of Anaesthesia, Main Operation Theatre, Tata Main Hospital, C Road(West), Northern Town, Bistupur, Jamshedpur-831001, Kolhan division.
Purbi Singhbhum
JHARKHAND |
9029041778
himanshi06saini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: W19||Unspecified fall, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparison between Ultrasound guided Axillary brachial plexus block for surgeries of wrist hand and distal forearm. |
The quality and duration of motor movement around the elbow will be measured in ultrasound guided axillary brachial plexus block. |
| Comparator Agent |
Ultrasound guided peripheral nerve block of five individual nerves, Medial, Ulnar, Radial, Median ante-brachial, Lateral ante-brachial nerves for wrist, hand and distal forearm surgeries. |
The quality and duration of motor movement around the elbow will be measured in ultrasound guided peripheral nerve blocks of five individual nerves. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective hand, wrist and distal forearm surgey.
ASA grades 1-3
|
|
| ExclusionCriteria |
| Details |
Patient refusal.
Patients with contraindications to regional anaesthesia.
History of peripheral neuropathy or nerve injury.
Infection at the site block.
History of allergy to local anaethetics. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the quality and the duration of motor blockade of the elbow, wrist joint and fingers. |
0 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare onset of action and duration of sensory blockade, duration of post operative analgesia, total opioid requirement for 24 hour post operative period, the time taken for the procedure and percentage conversion to general anaesthesia. |
0 minute, 2 minutes, 4 minutes, 6 minutes, 8 minutes, 10 minutes, 12 minutes, 14 minutes, 16 minutes, 18 minutes, 20 minutes, 22 minutes, 24 minutes, 26 minutes, 28 minutes, 30 minutes. |
|
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Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
09/04/2026 |
| 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="7"
Days="18" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
The topic of my thesis is a comparison between Axillary brachial plexus block and peripheral nerve block of 5 nerves around the elbow using ultrasound in patients undergoing surgeries of the wrist, hand and distal forearm, a randomised single blind trial. Axillary brachial plexus block is associated with prolonged motor paralysis at the elbow and digits and a chance of inadvertent arterial puncture. Peripheral nerve blocks around the elbow preserves motor function, improves mobility at the elbow improving patient satisfaction. There is no study with blocks of Lateral and Medial antebrachial cutaneous nerves along with Radial,Ulnar and Median nerve blocks. Primary objective is to compare the quality and duration of the motor blockade of elbow, wrist joint and fingers. The secondary objective is to compare the onset of action and duration of sensory blockade, duration of post operative analgesia, total opioid requirement for 24 hour post operative period, time taken for the procedure, percentage conversion to general anaesthesia. The total sample size of the study is 102. Blocks will be performed by an anaesthesiologist who had previously done 25 or more axillary brachial plexus blocks and individual peripheral nerve blocks before the commencement of study. Assessment will be done at a 5 minute interval till 30 minutes. Motor block will be assessed for flexion and extension of the elbow, wrist and finger flexion and opponens of the thumb. Sensory block will be assessed every 2 minutes for 30 minutes for loss of pinprick discrimination. Block is deemed as incomplete if patient feels pain at the end of 30 minutes and GA will be instituted. Post operative VAS scores and time of rescue analgesic will be noted. Data recording will be done using MS excel. Demographic statistics for continuous variables will be represented as Mean and that for categorical variables will be represented as frequency. Informed consent will be obtained, information of all participants will be kept confidential. There will be no additional financial implication.
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