| CTRI Number |
CTRI/2025/08/092495 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing three different approaches of a nerve block for patients undergoing humerus surgeries to assess the better technique for pain management. |
|
Scientific Title of Study
|
A study between three different ultrasound-guided techniques of
Intercostobrachial nerve block - distal approach versus proximal approach versus supra-axillary
approach in proximal humerus surgeries: A randomised three arm concurrent parallel clinical 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 |
Thamizh Thendral |
| Designation |
Assistant Professor |
| Affiliation |
Aarupadaiveedu Medical college and research institute |
| Address |
Department of Anaesthesiology
Aarupadaiveedu medical college
kirumampakkam, Puducherry 607402, India.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9789898804 |
| Fax |
|
| Email |
thendral4991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Thamizh Thendral |
| Designation |
Assistant Professor |
| Affiliation |
Aarupadaiveedu Medical college and research institute |
| Address |
Department of Anaesthesiology
Aarupadaiveedu medical college
kirumampakkam, Puducherry 607402, India.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9789898804 |
| Fax |
|
| Email |
thendral4991@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Thamizh Thendral |
| Designation |
Assistant Professor |
| Affiliation |
Aarupadaiveedu Medical college and research institute |
| Address |
Department of Anaesthesiology
Aarupadaiveedu medical college
kirumampakkam, Puducherry 607402, India.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9789898804 |
| Fax |
|
| Email |
thendral4991@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr.Thamizh Thendral. A |
| Address |
Department of Anaesthesiology,
Aarupadaiveedu medical college and hospital, Kirumambakkam.Puducherry- 607402, 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 Thamizh Thendral |
AarupadaiVeedu medical college |
Department of Anaesthesiology
1st floor, A block
Pondicherry
PONDICHERRY |
9789898804
thendral4991@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AVMC Institutional Human ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
intercostobrachial nerve block
(distal approach) |
3 mL of 0.25% ropivacaine + 3 mL of 2% lignocaine with adrenaline |
| Intervention |
intercostobrachial nerve block (distal approach) |
3 mL of 0.25% ropivacaine + 3 mL of 2% lignocaine with adrenaline |
| Comparator Agent |
intercostobrachial nerve block (supra axillary approach) |
5 mL of 0.25% ropivacaine + 5 mL
of 2% lignocaine with adrenaline |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2
BMI less than 30 |
|
| ExclusionCriteria |
| Details |
Patients unwilling to enroll for the study
Change in the plan of anaesthesia.
Patients with a history of allergy to the drugs used in the study
Patients with infection at the site of injection.
Duration of surgeries extending beyond 3hrs.
Neuropathy |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the analgesic efficacy in terms of onset of sensory blockade of ultrasound
guided Intercostobrachial Nerve Block by three different approaches - distal approach
versus proximal approach versus supra-axillary approach for patients undergoing
proximal humerus surgeries done via delto-pectoral approach. |
The Sensory block onset will be assessed every 2 minutes for 15
minutes via pinprick testing over the anteromedial and posteromedial upper arm. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the ease of technique in terms of duration of procedure |
Duration of the procedure will be recorded combining Landmark identification time (USG
localization of target area) and Block execution time (from needle insertion to withdrawal after
injecting the drug). |
| To assess the incidence of ICBN block failures. |
No sensory loss after 15 min after giving block will be noted |
| To assess analgesic efficacy post operatively using Visual analogue scale score. |
post operatively at at 0,2,4,6,12,
and 24 hours |
| To assess incidence of complications like hematoma, nerve injury and pneumothorax. |
while administering the nerve block |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 |
|
Date of First Enrollment (India)
|
27/08/2025 |
| 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="0"
Months="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - If requested to email, data will be shared -thendral4991@gmail.com
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Proximal humerus fractures are usually managed surgically using various approaches. Among which delto-pectoral approach is commonly used because of its familiarity, reduced scarring and also incision can be extended as needed. The Intercostobrachial nerve (ICBN) originates from lateral cutaneous branch of 2nd intercostal nerve, then it pierces the intercostal and serratus anterior muscles and then crosses the axilla to medial side of the arm and provides sensory innervation to medial surface of arm. This nerve is not consistently anaesthetized by standard brachial plexus blocks, leading to incomplete analgesia in anteromedial and posteromedial surface of arm during proximal humerus surgeries done by deltopectoral approach. Several approach to intercostobrachial nerve block exists, but the most effective method remains uncertain. In this study, we hypothesise that USG Guided supra-axillary approach of ICBN block would provide better analgesia compared to distal and proximal approach of ICBN block. |