| CTRI Number |
CTRI/2024/07/071716 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To know whether nerve block around collarbone has acted or not by knowing blood flow |
|
Scientific Title of Study
|
Evaluation of perfusion index as indicator for successful supraclavicular brachial plexus block |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shaik Asif |
| Designation |
Post graduate |
| Affiliation |
Dr B R Ambedkar medical college and hospital |
| Address |
First floor OT complex
Dr B R Ambedkar medical college and Hospital
Shampura main road
K G Halli
Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
07337275696 |
| Fax |
|
| Email |
asifshaik319@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Salim Iqbal |
| Designation |
Professor |
| Affiliation |
Dr B R Ambedkar medical college and hospital |
| Address |
First floor OT Complex
Department of Anesthesia
Dr B R Ambedkar medical college and Hospital
Shampura main road
K G Halli
Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
9964651079 |
| Fax |
|
| Email |
drsalim_iqbal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shaik Asif |
| Designation |
Post graduate |
| Affiliation |
Dr B R Ambedkar medical college and hospital |
| Address |
First floor OT Complex
Dr B R Ambedkar Medical College and Hospital
Shampura main road
K G Halli
Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
7337275696 |
| Fax |
|
| Email |
asifshaik319@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr B R Ambedkar Medical College and Hospital
Shampura main road
K G Halli
Bangalore
Karnataka
560045 |
|
|
Primary Sponsor
|
| Name |
Shaik Asif |
| Address |
1st floor OT Complex
Department of Anesthesiology
Dr B R Ambedkar Medical College and Hospital
Shampura main road
K G Halli
Bangalore |
| 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 Shaik Asif |
Dr B R. Ambedkar Medical College and Hospital |
First floor OT Complex
Department of Anesthesiology
Dr B R Ambedkar Medical College and Hospital
Shampura Main Road
K G Halli
Bangalore
Bangalore
KARNATAKA |
7337275696
asifshaik319@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION ETHICS COMMITTEE(IEC) DR.B R Ambedkar Medical College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients posted for elective upper extremities surgery
2 American Society of Anesthesiologists(ASA)class 1,2,3 |
|
| ExclusionCriteria |
| Details |
1 Patients with history of known allergies to Bupivacaine
2 Alcoholism, Drug abuse, Psychological or other emotional problems that are likely to invalidate the informed consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the variations in perfusion index value after supraclavicular brachial plexus block |
30 min after block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To calculate the cutoff value of Pi for successful supraclavicular brachial plexus block
2.Compare the changes in Pi value between successful and unsuccessful supraclavicular brachial plexus block
3.To assess grades of sensory/motor block and complications if any |
30 minutes after block |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2024 |
| 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
|
Peripheral nerve block is one of the commonly used blocks in regional anesthesia. Peripheral nerve blocks provide more advantageous condition in cases where general or spinal anesthesia is risky as in heart, kidney, respiratory disease, chest trauma and diabetic patients. Block is limited to the region covering the area innervated by the plexus or terminal branches. |