| CTRI Number |
CTRI/2025/10/096521 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Reducing the tourniquet pain by using Ultrasound guided intercostobrachial nerve block following axillary brachial plexus block during forearm surgeries. |
|
Scientific Title of Study
|
Effect of ultrasound guided and landmark guided intercostobrachial nerve block on tourniquet pain following axillary brachial plexus block in patients undergoing forearm surgeries A Double blinded randomized 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 Dinesh Naik |
| Designation |
Professor |
| Affiliation |
S Nijalingappa medical college |
| Address |
Department of Anaesthesiology
SNMC and HSK hospital ,BAGALKOT-587102
India
Bagalkot
KARNATAKA
587102
India |
| Phone |
9986514559 |
| Fax |
|
| Email |
dinesh.jnmc2002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Naik |
| Designation |
Professor |
| Affiliation |
S Nijalingappa medical college |
| Address |
Department of Anaesthesiology SNMC and HSK hospital ,BAGALKOT-587102
India
Bagalkot
KARNATAKA
587102
India |
| Phone |
9986514559 |
| Fax |
|
| Email |
dinesh.jnmc2002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soumya |
| Designation |
Junior Resident |
| Affiliation |
S Nijalingappa medical college |
| Address |
Department of Anaesthesiology
SNMC and HSK hospital ,BAGALKOT-587102
India
Bagalkot
KARNATAKA
587102
India |
| Phone |
7892183131 |
| Fax |
|
| Email |
soumya2177@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patients coming to S Nijalingappa Medical College and HSK hospital,Nvanagar Bagalkot,India
pincode-587103
who are posted for forearm surgeries. |
|
|
Primary Sponsor
|
| Name |
S Nijalingappa Medical college |
| Address |
Department of Anaesthesiology,
Second floor, S NIjalingappa medical college and HSK hospital
,Navanagar,Bagalkot,India Pincode-587103 |
| 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 Dinesh Naik |
S Nijalingappa Medical college and HSK Hospital, |
Ortho OT Complex ,Ground floor ,S nijalingappa medical college and HSK hospital,Navanagar Bagalkot 587103
Bagalkot
KARNATAKA |
09986514559
dinesh.jnmc2002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S NIJALINGAPPA MEDICAL COLLEGE AND HANAGAL SHRI KUMARESHWAR HOSPITAL AND RESEARCH CENTRE BAGALKOT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Forearm surgeries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Axillary nerve block |
The axillary block(control group) will be performed by injecting 30 mL of 1.5%
lignocaine with adrenaline using US guidance and next to each nerve, 6-8mL of 1.5%
lignocaine with adrenaline injected. |
| Intervention |
Landmark guided-Intercostobrachial nerve block |
the ICBN block will be performed without US guidance and based
on the landmark using superficial anatomy and nerve pathway by subcutaneous injection
of 6mL of 1.5% lignocaine with adrenaline at the site of the axillary pulse. |
| Intervention |
Ultrasound guided-Intercostobrachial nerve block |
ICBN will be
identified by sonography on the axillary artery and superficial to deep fascia; the block
will be performed by injecting 6mL of 1.5% lignocaine with adrenaline. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anaesthesiologists(ASA) physical status I-II
Indication of forearm and hand surgery lasting at least 90minutes
Body mass index between 23 and 28
|
|
| ExclusionCriteria |
| Details |
History of allergy to local anaesthetics
Coagulation problems
Upper extremity neuropathy
Vasculitis
Unstable hemodynamics
History of seizures
Patient who cannot communicate with investigator
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduced tourniquet pain and delayed onset of pain during forearm surgeries.
Ultrasound -guided intercostobrachial nerve (ICBN) block may offer greater accuracy and
effectiveness compared to the traditional landmark-guided technique.
|
Intraoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Consumption of rescue analgesics with the onset of tourniquet pain |
Intraoperative |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
10/11/2025 |
| 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
|
•The aim of this study is to compare
the intensity of tourniquet induced pain between the group A(Ultrasound guided
Axillary block),group B(Ultrasound guided axillary block with landmark guided
Intercostobrachial nerve block),group C(Ultrasound guided Axillary block with
Ultrasound guided Intercostobrachial nerve block) following axillary brachial
plexus block in patients undergoing forearm surgeries.
And
also To compare the onset of tourniquet pain
between the study groups and To compare
the total analgesics consumption between the study
groups
•The axillary
block of the brachial plexus is a routine and efficient method for anesthesia
of the upper limb during forearm and hand surgery . A tourniquet is used to
control bleeding in the surgical field.Application
of
tourniquet can cause intolerable dull, achy pain in the tissues underneath.Tourniquet
pain
may have cutaneous and ischemic components.Despite
the
axillary block , a tourniquet can cause pain that is not tolerable for the
patient and disrupts the surgical process, because part of the inner arm is
innervated by the intercostobrachial nerve lateral
cutaneous branch of the second intercostal nerve (i.e
ICBN)
•The intercostobrachial
nerve (ICBN) is a pure sensory nerve that arises primarily from the second
intercostal nerve (T2).The posterolateral
and medial aspect of the arm is supplied by the axillary (AXN) and
intercostobrachial nerves (ICBN), which are not anaesthetised by an axillary
brachial plexus block (ABPB)
•Blocking
the
brachial plexus in the axillary area has no side effects (such as pneumothorax,
phrenic nerve injury, and recurrent laryngeal nerve injury), as seen with other
methods of blocking this plexus, making it the most suitable approach. It
seems
that in addition to the axillary block of the brachial plexus, this problem can
be overcome by blocking the ICBN. Therefore, in the present clinical trial, in
addition to axillary block in patients with surgery of the hand and forearm, we
also block the ICBN to examine whether the pain caused by a tourniquet during
surgery disappears.
•Hence
this
study is to compare Intercostobrachial nerve (ICBN) block with and without
Ultrasound guidance in reducing the intensity of tourniquet induced pain during
the axillary block in forearm surgeries.
The
use
of an ICBN block may associated with reduced tourniquet pain and delayed onset
of pain during the procedure. Ultrasound -guided intercostobrachial nerve
(ICBN) block may offer greater accuracy and effectiveness compared to the landmark-guided
technique |