| CTRI Number |
CTRI/2025/10/095886 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
“Evaluating Block Onset, Ease of Performance and Safety in different costoclavicular Brachial Plexus Block Techniques: Medial and Lateral by using ultrasound in patients undergoing upper limb surgery |
|
Scientific Title of Study
|
Comparative evaluation of performance and block charachterstics of medial versus lateral approach to ultrasound guided Costoclavicular Brachial Plexus block in patients undergoing upper limb surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bahadur Singh |
| Designation |
Post Graduate Student |
| Affiliation |
ESIC Medical College and Hospital Faridabad Haryana |
| Address |
Department Of Anaesthesia
ESIC Medical College and Hospital
Faridabad
Faridabad HARYANA 121001 India |
| Phone |
8930680081 |
| Fax |
|
| Email |
sdrbahadur@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Rama Wason |
| Designation |
Professor |
| Affiliation |
ESIC Medical College and Hospital Faridabad Haryana |
| Address |
Department Of Anaesthesia
ESIC Medical College and Hospital
Faridabad
Faridabad HARYANA 121001 India |
| Phone |
8930680081 |
| Fax |
|
| Email |
nupur4@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Rama Wason |
| Designation |
Professor |
| Affiliation |
ESIC Medical College and Hospital Faridabad Haryana |
| Address |
Department Of Anaesthesia
ESIC Medical College and Hospital
Faridabad
Faridabad HARYANA 121001 India |
| Phone |
8930680081 |
| Fax |
|
| Email |
nupur4@hotmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical College and Hospital Faridabad 121001 Haryana India |
|
|
Primary Sponsor
|
| Name |
Dr Bahadur Singh |
| Address |
Department Of Anaesthesiology ESIC Medical College and Hospital Faridabad |
| 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 Bahadur Singh |
ESIC Medical College and Hospital |
Department Of Anaesthesia ESIC Medical College And Hospital Faridabad Faridabad HARYANA |
8930680081
sdrbahadur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ESIC Medical College and Hospital |
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 |
| Comparator Agent |
Approach of Costoclavicular Brachial Blexus Block |
Two group will be formed
group M needle will advance from medial to lateral
Group L needle will advance from lateral to medial
Comparison Of USG Guided Medial Vs Lateral Approach Of The Block using single injection of 20 cc bupivacaine 0.5%.After LA injection composite sensorimotor score was calculated for Musculocutaneous Median Radial and Ulner nerve every 5 minutes to 30 minutes. |
| Intervention |
Costoclavicular Brachial Plexus Block |
Two group will be formed
group M needle will advance from medial to lateral
Group L needle will advance from lateral to medial
Comparison Of USG Guided Medial Vs Lateral Approach Of The Block using single injection of 20 cc bupivacaine 0.5%.After LA injection composite sensorimotor score was calculated for Musculocutaneous Median Radial and Ulner nerve every 5 minutes to 30 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists physical status I or II
BMI less than 30 |
|
| ExclusionCriteria |
| Details |
Infection at block site
history of allergy to local anaesthetiC
patients with history of coagulopathy or bleeding disorders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the performance time of ultrasound-guided costoclavicular brachial plexus block using medial versus lateral approach in patients undergoing upper limb surgeries. |
30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare
The needle passes
The time taken to achieve the composite sensorimotor score of 14
The diaphragmatic excursion (in cm) .
The incidence of complications (e.g., vascular punctures, pneumothorax, )
of medial versus lateral approach of ultrasound guided costoclavicular brachial plexus block in patients undergoing upper limb surgeries
|
30 minutes |
|
|
Target Sample Size
|
Total Sample Size="57" Sample Size from India="57"
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)
|
20/10/2025 |
| 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
|
This thesis protocol focuses on comparing the medial versus lateral approaches to ultrasound-guided costoclavicular brachial plexus block in patients undergoing upper limb surgery.
Key Points
Background Brachial plexus blocks are commonly used for upper limb surgeries. The costoclavicular approach offers consistent visualization and reduced complications compared to traditional techniques. However, the medial and lateral approaches to CCB differ in performance ease risk of vascular puncture and block characteristics. Research Gap Limited studies have directly compared medial and lateral CCB techniques especially regarding onset time performance difficulty and complications. Aim & Objectives Primary Compare performance time between medial and lateral approaches. Secondary Assess needle passes onset of sensorimotor block diaphragmatic excursion block success and complications as vascular puncture pneumothorax. Methods Design Randomized controlled trial from October 2025 to March 2027. Sample Size 54 patients as27 in each group. Participants Adults aged 18–65 years ASA I/II BMI less than 30 kg/m². Exclusion Infection at block site allergy to local anaesthetic bleeding disorders. Groups Group L Lateral to medial CCB with 20 ml of 0.5% bupivacaine. Group M Medial to lateral CCB with the same drug. Outcome Measures Imaging time needling time performance time sensorimotor block scores diaphragmatic excursion complications and patient satisfaction. Statistical Plan Data analyzed using SPSS v23, with t-tests/ANOVA for continuous data, Chi-square or Fisher’s test for categorical data and p less than 0.05 as significant. Ethics Institutional Ethical Committee approval obtained. Informed consent will be taken from all participants.
Conclusion of The study aims to clarify whether medial or lateral ultrasound-guided costoclavicular approaches provide better performance and clinical outcomes and helping anaesthesiologists choose the safer and more efficient method for upper limb surgeries. |