| CTRI Number |
CTRI/2025/05/086775 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
15/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Randomized control trial of comparison between selective blockade of supraclavicular nerves and upper trunk of brachial plexus called the scut block and conventional interscalene blocks for clavicle surgeries. |
|
Scientific Title of Study
|
COMPARISON BETWEEN SELECTIVE BLOCKADE OF SUPRACLAVICULAR NERVES AND UPPER TRUNK OF BRACHIAL PLEXUS “THE SCUT BLOCK” AND CONVENTIONAL INTERSCALENE BLOCKS FOR CLAVICLE SURGERIES: A RANDOMIZED CONTROL 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 |
sripriyankaR |
| Designation |
Assistant Professor |
| Affiliation |
ACS Medical College and Hospital |
| Address |
No:28, Sri ram nagar extension
Paruthipattu
Avadi,chennai
Chennai
TAMIL NADU
600071
India |
| Phone |
9500501695 |
| Fax |
|
| Email |
sripriyanka2712@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
sripriyankaR |
| Designation |
Assistant Professor |
| Affiliation |
ACS Medical College and Hospital |
| Address |
No:28, Sri ram nagar extension
Paruthipattu
Avadi,chennai
Duty Anaesthesiologist Room, OG OT complex, ACS Medical college and hospital , velappanchavadi, poonamalli high road, Chennai-60071
Chennai
TAMIL NADU
600071
India |
| Phone |
9500501695 |
| Fax |
|
| Email |
sripriyanka2712@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
sripriyankaR |
| Designation |
Assistant Professor |
| Affiliation |
ACS Medical College and Hospital |
| Address |
No:28, Sri ram nagar extension
Paruthipattu
Avadi,chennai
Duty anaesthesiologist room, OG OT Complex, ACS Medical college and hospital , velappanchavadi, poonamalli high road, Chennai- 600071
Chennai
TAMIL NADU
600071
India |
| Phone |
9500501695 |
| Fax |
|
| Email |
sripriyanka2712@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia
ACS medical college and hospital
Poonamalli high road
velappanchavady
Chennai-600077 |
|
|
Primary Sponsor
|
| Name |
ACS Medical college and Hospital |
| Address |
ACS medical college and hospital
poonamalli high road
vellapanchavady
Chennai -600077 |
| 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 Sripriyanka R |
ACS medical college and hospital |
Department of anaesthesia operational theatre complex ACS medical college and hospital poonamallee high road velappanchavadi
Chennai
Chennai
TAMIL NADU |
9500501695
sripriyanka2712@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACS medical college hospital Dr.MGR educational and research institute (deemed to be university) Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S420||Fracture of clavicle, (2) ICD-10 Condition: S420||Fracture of clavicle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A we give supraclavicular and upper trunk block |
we take around 120 patients into trial and we give supraclavicular and upper trunk block to group A patients with 10 ml of 0.5% ropivacaine will be administered under ultrasound guidance |
| Comparator Agent |
Group B we give interscalene and suoraclavicular |
60 patients are in group B for these patients we give interscalene and supraclavicular block using a larger volume of 20 to 30 ml of ropivacaine |
| Intervention |
Supra clavicular nerve and upper trunk block compared with inter scalene brachial plexus block and supra clavicualr nerve block |
To compare the effectiveness and safety of the
selective blockade of supraclavicular nerves and upper trunk of the brachial plexus called as SCUT block with the conventional interscalene block in patients undergoing clavicle surgeries. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18–70 undergoing clavicle surgery (e.g., open reduction and internal
fixation
• ASA (American Society of Anaesthesiologists) physical status I–III.
• Patients providing informed consent for participation in the trial. |
|
| ExclusionCriteria |
| Details |
Patient refusal for surgery
Bleeding diathesis
Infection at the site of surgery
Polytrauma |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the post-op pain score - measured using Visual Analog Scale (VAS)
• To compare the incidence of diaphragmatic paralysis - associated with USG guidance.
|
till 12 hours post op |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the post-op opioid consumption.
• To compare the patient satisfaction
• To compare the surgeon satisfaction
• To compare the time to first opioid reuse analgesia.
|
24 hours post procedure |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
30/05/2025 |
| 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="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Regional anesthesia has been shown to improve patient outcomes in upper limb surgeries but a site specific approach for clavicle surgeries remain under developed. Traditionally the combination of interscalene brachial plexus block and superficial cervical plexus block has been used. however these techniques are not selective for clavicular innervation. Anatomical studies has identified four primary nerves responsible for clavicular sensation. They are superaclavicular nerve from the cervical plexus, nerve to subclavius, supra scapular nerve and long thoracic nerve from the brachial plexus.
SCUT that is supraclavicular and upper trunk blocks was developed to provide targeted anesthesia by selectively blocking the supraclavicular nerve and the upper trunk of brachial plexus. This study is prospective randomised double blinded controlled trial comparing the efficacy and safety of the SCUT block versus the conventional interscalene brachial plexus block in clavicle surgeries. The primary objective include evaluating postoperative pain score that is the visual analogue score and the incidence of diaphragmatic paralysis. While secondary objectives assess the opioid consumption that is the time fro the first opioid use and patient surgeon satisfaction.
A total of 120 patients will be randomised into two groups
1. Group A. SSCUT block with 10 ml of 0.5% ropivacaine will be administered under ultrasound guidance 2. Group B Interscalene and spra clavicular block using a larger volume of 20 to 30 ml of ropivacaine
Pain scores will be recored at time points intra operatively and post operatively. Respiratory function will be assessed using ultrasound at 1 and 6 hours post block. Statistical analysis will compare visual analogue scores, opioid use, patient satisfaction and complication rates.
This study aims to establish the SCUT block as a safer and more effective alternative to interscalene brachial plexus block by reducing the risk of diaphragmatic paralysis while providing adequate analgesia for clavicle surgeries.
|