| CTRI Number |
CTRI/2017/08/009264 [Registered on: 04/08/2017] Trial Registered Prospectively |
| Last Modified On: |
04/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Is the numbing of the elbow and hand for surgeries effective by two different techniques? |
|
Scientific Title of Study
|
Efficacy of local anaesthetic drug deposited at lateral cord and posterior cord in infraclavicular brachial plexus block: A prospective, randomized, comparative, pilot study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vrushali C Ponde |
| Designation |
Pediatric Anaesthesiologist |
| Affiliation |
Surya Childrens Hospital, Santacruz, Mumbai |
| Address |
Surya Children Hospital.
OT, first floor
S V road
Santacruz 400054
Mumbai (Suburban)
MAHARASHTRA
400054
India |
| Phone |
9819886502 |
| Fax |
|
| Email |
vrushaliponde@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vrushali C Ponde |
| Designation |
Pediatric Anaesthesiologist |
| Affiliation |
Surya Childrens Hospital, Santacruz, Mumbai |
| Address |
Surya Children Hospital.
OT, first floor
S V road
Santacruz 400054
Surya Children Hospital.
OT, first floor
S V road
Santacruz 400054
Mumbai (Suburban)
MAHARASHTRA
400054
India |
| Phone |
9819886502 |
| Fax |
|
| Email |
vrushaliponde@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vrushali C Ponde |
| Designation |
Pediatric Anaesthesiologist |
| Affiliation |
Surya Childrens Hospital, Santacruz, Mumbai |
| Address |
Surya Children Hospital.
OT, first floor
S V road
Santacruz 400054
Mumbai (Suburban)
MAHARASHTRA
400050
India |
| Phone |
9819886502 |
| Fax |
|
| Email |
vrushaliponde@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Surya Children Hospital.
OT, first floor
S V road
Santacruz 400054 |
|
|
Primary Sponsor
|
| Name |
Surya Children Hospital |
| Address |
SV Road, Santacruz West, Mumbai |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vrushali C Ponde |
Surya Childrens Hospital |
Operation Theater, first floor
Department Of Anesthesia Santacruz west, SV Road, Mumbai
Mumbai (Suburban)
MAHARASHTRA |
9819886502
9819886502
vrushaliponde@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Academic research ethics committee, Surya Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA1 and 2 patients posted for forearm surgeries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brachial Plexus for upper extremity surgeries |
Group L:Needle tip placement and Local anesthetic deposition at lateral cord under ultrasonography
Group P :
Needle tip placement and Local anesthetic deposited at posterior cord under ultrasonography
|
| Comparator Agent |
Comparison of efficacy at lateral and posterior cords |
analgesia and Pain relief offered by local anesthetic drug deposited at posterior and lateral cords was compared |
|
|
Inclusion Criteria
|
| Age From |
7.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 patients posted for forearm surgeries |
|
| ExclusionCriteria |
| Details |
Any patient with a history of severe cardiac, renal, neurological or pulmonary disease, coagulopathy and refusal to consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy |
Intraoperative heart rate at the Surgical incision |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative pain relief |
Post operative period |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
10/08/2017 |
| Date of Study Completion (India) |
01/11/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hypothesis: Local anaesthetic deposited at the lateral cord or the posterior cord should render an equally effective block in pediatric patients. Methods: Inclusion and exclusion of patients, Monitoring, induction and maintatinence of block and ultrasound guided infraclavicular block will be done as per protocol. The patients will be diided into a group of 10 each into group L and group P, whereby the needle placement would be at the lateral cord and posterior cord repectively under ultrasound guidance. Radio opaque dye spread will also be assessed as per protocol. The patients will recieve continous infusion of local anaesthetic through the respective infraclavicular block as per protocol and rescue analgesia will be given as per protocol. The data will be analyzed for any differences. |