| CTRI Number |
CTRI/2022/10/046876 [Registered on: 28/10/2022] Trial Registered Prospectively |
| Last Modified On: |
27/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the nerve block characteristics between axillary and infraclavicular approaches of nerves supplying the forearm under ultrasound guidance. |
|
Scientific Title of Study
|
Comparison of block characteristics between proximal axillary and infraclavicular approaches of brachial plexus block under ultrasound guidance for forearm surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tharmalingam Ashwin |
| Designation |
Post-Graduate |
| Affiliation |
ESIC MEDICAL COLLEGE & PGIMSR KK NAGAR |
| Address |
1st year postgraduate
Department of anaesthesiology
ESIC PGIMSR
KK Nagar
Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
9354562442 |
| Fax |
|
| Email |
ashwintharmalingam08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ILANGO GANESAN |
| Designation |
Proffesor And Head Of Department |
| Affiliation |
ESIC MEDICAL COLLEGE AND PGIMSR KK NAGAR |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
ESIC MEDICAL COLLEGE AND PGIMSR
KK NAGAR
CHENNAI
Chennai
TAMIL NADU
600078
India |
| Phone |
9884149429 |
| Fax |
|
| Email |
gilang@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ILANGO GANESAN |
| Designation |
Proffesor And Head Of Department |
| Affiliation |
ESIC MEDICAL COLLEGE AND PGIMSR KK NAGAR |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
ESIC MEDICAL COLLEGE AND PGIMSR
KK NAGAR
CHENNAI
Chennai
TAMIL NADU
600078
India |
| Phone |
9884149429 |
| Fax |
|
| Email |
gilang@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC MEDICAL COLLEGE AND PGIMSR KK NAGAR CHENNAI 600078 |
|
|
Primary Sponsor
|
| Name |
ESIC MEDICAL COLLEGE AND PGIMSR |
| Address |
ESIC MEDICAL COLLEGE AND PGIMSR
KK NAGAR
CHENNAI 600078 |
| Type of Sponsor |
Government 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 |
| THARMALINGAM ASHWIN |
ESIC MEDICAL COLLEGE AND PGIMSR |
DEPARTMENT OF ANAESTHESIOLOGY
ESIC MEDICAL COLLEGE AND PGIMSR
KK NAGAR
Chennai
TAMIL NADU |
9354562442
ashwintharmalingam08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS 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 |
| Comparator Agent |
Infraclavicular Brachial Plexus Block |
Infraclavicular approach of brachial plexus block under ultrasound guidance for forearm surgeries with Inj.Ropivacaine 0.5% 29ml + Inj.Dexmedetomidene 1ml
Block performance time 10- 15 mins |
| Intervention |
Proximal Axillary Brachial Plexus Block |
Proximal axillary approach of brachial plexus block under ultrasound guidance for forearm surgeries with Inj.Ropivacaine 0.5% 29ml + Inj.Dexmedetomidine 1ml
Block performance time 8- 10 mins |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA grade I&II
2.Male and Female gender.
3.Age 18- 60years,
4.Posted for forearm surgery
5. Patients weighing in the range of 45 - 65kg.
6. Patient consent
|
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.ASA grade III or above
3.Patient with thoracic skeletal abnormalities
4.Upper limb skeletal abnormalities
5.Allergic to amide local anaesthetic
6.Patients with chest injuries and hemopneumothorax
7.Pregnancy
8.Clavicle fracture
9.Local site infection
10.Bleeding disorders
11.Pre-existing sensory and motor neuropathy
12.Known case of seizure disorder
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ONSET OF SENSORY AND MOTOR BLOCKADE AND BLOCK PERFORMANCE TIME |
15mins, 30mins, 1hr, 2hr,4hr,6hr,8hr,10hr, 12hr, 24 hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The duration of block ( time taken for first rescue analgesic dose following block), shortfalls like sparing of dermatomes and complications |
15mins, 30mins, 1hr, 2hr, 4hr, 6hr, 8hr, 10hr, 12hr, 24 hr for time taken for sparring of sensory and motor blockade |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
01/11/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To compare the block characteristics between proximal axillary and infraclavicular approach of brachial plexus block under ultrasound guidance in patients admitted for forearm surgeries with Inj.Ropivacaine and Inj.Dexmedetomidine and will assess the onset of sensory and motor blockade , block performance following the respective approaches of brachial plexus block. |