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CTRI Number  CTRI/2025/02/081315 [Registered on: 25/02/2025] Trial Registered Prospectively
Last Modified On: 24/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Comparison of efficacy of ultrasound guided intercostobrachial nerve block (ICBN) using two different approaches 
Scientific Title of Study   Comparison of efficacy of ultrasound guided intercostobrachial nerve block (ICBN) using two different approaches in patients posted for below elbow surgery with tourniquet under brachial plexus block a prospective observational 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  Mangesh Gurudeo Durge 
Designation  Post graduate resident 
Affiliation  Lokmanya tilak municiple medical college and general hospital mumbai 
Address  Department of Anaesthesia Lokmanya Tilak Municipal Medical College and General Hospital Sion Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  7875737741  
Fax    
Email  mangeshdurge26@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shruti Patil 
Designation  Associate Professor (Addl) 
Affiliation  Lokmanya Tilak Municipal Medical College and General Hospital Sion Mumbai  
Address  Department of Anaesthesia Lokmanya Tilak Municipal Medical College and General Hospital Sion Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9619153353  
Fax    
Email  dr.shrutipatil@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shruti Patil 
Designation  Associate Professor (Addl) 
Affiliation  Lokmanya Tilak Municipal Medical College and General Hospital Sion Mumbai  
Address  Department of Anaesthesia Lokmanya Tilak Municipal Medical College and General Hospital Sion Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9619153353  
Fax    
Email  dr.shrutipatil@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesia Lokmanya Tilak Municipal Medical College& General Hospital, Sion, Mumbai ,Maharashtra 400022 
 
Primary Sponsor  
Name  Mangesh Gurudeo Durge 
Address  Department of Anaesthesia Lokmanya Tilak Municipal Medical College and General Hospital Sion Mumbai  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Shruti Patil   Department of anaesthesia Lokmanya Tilak Municipal Medical College and General Hospital Sion Mumbai  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mangesh Gurudeo Durge  Lokmanya Tilak Munciple Medical Collage and Hospital  Department Of Anaesthesia Lokmanya Tilak Munciple Medical Collage and Sion Hospital Mumbai
Mumbai
MAHARASHTRA 
7875737741

mangeshdurge26@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.
Signed written informed consent
2.
American Society of Anesthesiologists (ASA) physical status I to III
3.
Age 18 to 75 years old
4.
Those suitable for surgery under brachial plexus block
5.
Operative site at the elbow, forearm, wrist, or hand
6.
Surgery requiring tourniquet placement 
 
ExclusionCriteria 
Details  Patients with contraindications to BPB, not requiring tourniquet, requiring GA or with body mass index (BMI) more than 35 kg.m2 will be excluded 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To observe difference in the efficacy of USG guided ICBN block perform by two techniques ICBN1 and ICBN2  20 minutes  
 
Secondary Outcome  
Outcome  TimePoints 
1 Visualization of the ICBN nerve yes or no
2 To observe the difference in the number of needle passes
3 To observe the difference in the block performance time
4 To observe the difference in the time to complete sensory anaesthesia at the T2 dermatome
5 Quality of sensory anaesthesia measured on a scale 0 to 2 at the end of 20 min between the two techniques. (tested by pin prick on the medial aspect of the upper arm)
6 Additional sedation & opioids read to tolerate the tourniquet
7.To observe the difference time to complete sensory recovry
8.To note complications 
20min 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   22/03/2025 
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="2"
Months="0"
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  

The intercostobrachial nerve (ICBN) is a pure sensory nerve that arises primarily from the second intercostal nerve (T2) with occasional contribution from T3. In its extra-thoracic course, the ICBN runs parallel to the axillary vein at a distance of approximately 1.5 cm in a vertical dimension and provides sensory supply to the axilla, upper medial arm, and a small area at the upper lateral chest wall.1,2

It is not a component of the brachial plexus and hence not anesthetized by brachial plexus blockade. Clinically, ICBN blockade is necessary for any surgical procedure where the surgical incision extends into the axilla, or upper medial arm and to tolerate the tourniquet.3,4(Fig 1)

Inflation of the tourniquet by closing the tourniquet to control bleeding in the surgical field after 30 to 45 minutes can lead to relatively severe pain.5Hence ICBN block is a constant accompaniment of the brachial plexus block to control tourniquet pain in below elbow upper limb surgeries. Blocking this nerve can be done by 2 methods: (1) LA injection in the nerve pathway using superficial nerve anatomy (along the axillary vein in the midaxillary line); and (2) LA injection with US guidance and thus selective ICBN blockade.4 ICBN blockade at the axilla under USG has been more often practiced than other approaches hence has enough supporting literature. 1,2,3,4 There is relative dearth of literature regarding other approaches for ICBN blockade for example over the lateral chest wall or over T2 rib. 3,4,5

We have chosen to compare two USG techniques: the distal, more common approach at the axilla studied by various authors ( Wisotzsky et al, Magazzeni et al, Samsoudi et al) (ICBN1) and  the proximal approach over the chest wall described by Thallaj et al (ICBN2) 1-4

In addition the volume used by various authors is not consistent. Also high resolution USG has provided better visualization of the nerve compared to conventional USG. 6,7,8 Thus here we intend to compare the proximal and the distal approaches with respect to analgesic efficacy, nerve visualization using conventional USG. 9-12

Research Question:

Does the ICBN 1 technique have better analgesic efficacy compared to ICBN 2 technique?

Hypothesis:

There is no significant difference in analgesic efficacy between ICBN1 and ICBN2

 

Aims: To observe difference in the efficacy of USG Guided ICBN block performed by two techniques ICBN 1 and ICBN 2 in addition in to the BPB 

 

1.     Primary Objective:

     To observe the difference in the to observe the difference in the tourniquet tolerance (VAS 0-10)

 

2.     Secondary Objective:

1.     Visualization of the ICBN nerve: yes or no

2.     To observe the difference in the number of needle passes,

3.     To observe the difference in the block performance time

4.     To observe the difference in the time to complete sensory anaesthesia at the T2 dermatome

5.     Quality of sensory anaesthesia measured on a scale 0-2 at the end of 20 min between the two techniques. (tested by pin prick on the medial aspect of the upper arm)

6.     Additional sedation and opioids read to tolerate the tourniquet

7.     To observe the difference time to complete sensory recovery and

8.     To note complications (nerve injury, last, block failure)

 

After institutional Ethics Committee approval this study will be conducted on 42 consenting individuals satisfying the inclusion criteria and exclusion criteria. The Routine protocol is as follows: pre anaesthetic checkup as per OT protocol, written informed consent is taken. Standard ASA monitors (non-invasive cuff blood pressure, pulse oxygen saturation, and electrocardiogram) are applied and supplemental oxygen (nasal cannula at 2 L/ min) is given. Intravenous access is secured and I.V Fluid is started. Sedation in the form of Inj fentanyl 1ug/kg and 1mg/kg Inj midazolam is administered. Ultrasound-guided suitable brachial plexus block is administered. The intercostobrachial block (ICBN) is routinely performed for tourniquet placement using subcutaneous infiltration technique or one of the ultrasound guided techniques described by various authors. For this study patients who receive USG guided ICBN block using distal (ICBN 1) or proximal approach (ICBN 2) will be included .1,2,3 This will be administered by a senior anaesthetist experienced in regional anaesthesia.

After standard skin disinfection the block is performed with a portable ultrasound machine and 50- mm short-beveled stimulating needle. Suitable BPB (Axillary, supraclavicular, infraclavicular) is performed for the below elbow surgery as per the anaesthetist (10 cc 0.75% ropivacaine and 10cc 2% lignocaine with adrenaline). This is followed by USG  guided  ICBN  block using 0.25% of  ropivacaine 5 ml.

 

Technique for ICBN 1: The ultrasound-guided ICBN block is administered as described by Wisokstzy et al, Magazenni et al and Samsoudis et al.1,2,4 Here the high-frequency probe is placed in the axilla and slid posteriorly towards the table to visualize the axillary vein and the conjoint tendon and latissimus dorsi muscle where the ICBN and possibly the medial branchial cutaneous nerve will be visualized. (Figure 2)

Technique for ICBN 2: The ultrasound guided ICBN block will be performed in accordance to the method described by Thallaj et al.3The probe is positioned at the apex of the axillary fossa to scan the axillary vein in the short axis view. The linear probe is slid proximally toward the base of the axilla, at a distance of approximately 6 cm proximal to the medial aspect of the humeral head and the axillary vein becomes deeper on the US screen and inferior to the postero-lateral border of the pectoralis major muscle (Figure 2A). The probe is then positioned slightly oblique, and the depth on the US screen is reduced for clear identification of the nerve in the cross-sectional view. At this point, the ICBN appears as a hyper-echoic oval structure surrounded by a fascial split, superior and posterior to the axillary vein, midway on an imaginary line crossing the borders of the pectoralis major and latissimus dorsi muscles as illustrated in Figure 3. Releasing the pressure applied on the US probe frequently revealed small, hypoechoic, rounded collapsible vessels anterior or posterior to the nerve.

After assessing sensory-motor block in the BPB area using a three point scale, sensory block is assessed using pin prick in the T2 dermatome using the three point scale

(0 = No Block, 1 = Partial Anesthesia, 2 = Complete Anaesthesia).

Complete sensory block in the T2 dermatome taking more than 30 min is considered block failure. Block performance time,(time from first needle entry to completion of drug injection), number of needle passes(no of needle redirections required),time to complete sensory recovery and complications(defined as vascular puncture, nerve injury/neuropathy, block failure+, local anaesthetic systemic toxicity) if any were monitored. 12-15

 

PARAMETERS TO BE STUDIED :

1.     Visualization of the ICBN nerve Y/N

2.     To observe difference in Block performance time

3.     To observe the difference in the number of needle passes,

4.     To observe the difference in the quality of sensory anaesthesia measured on a scale 0-2 (Fig) at the end of 20 min between the two techniques.                      (tested by pin prick on the medial aspect of the upper arm)

5.     To observe the difference in the time to complete sensory anaesthesia

6.     To observe the difference in the tourniquet tolerance (VAS 0-10 )

7.     Additional sedation and opioids read to tolerate the tourniquet

8.     To note the duration of tourniquet inflation

9.     To observe vital parameters such as SBP, DBP, HR.

10. To observe the difference in time to complete sensory recovery and motor recovery

11. To note complications (nerve injury, LAST, block failure)


 
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