| CTRI Number |
CTRI/2023/02/050089 [Registered on: 26/02/2023] Trial Registered Prospectively |
| Last Modified On: |
23/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In this study using ultrasound machine we want to measure the distance between pleura and brachial plexus in between two different positions i.e,regular supine position and lateral decubitus position in patients undergoing supraclavicular brachial plexus block for upper limb surgeries. |
|
Scientific Title of Study
|
"Comparision between lateral decubitus position and conventional supine position to determine the distance between pleura and brachial plexus in patients undergoing ultrasound guided supraclavicular brachial plexus block for upper limb surgeries: A Randomized Control Trial" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAVITEJA REDDY G S RN |
| Designation |
POST GRADUATE |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE,BELAGAVI |
| Address |
Department of Anaesthesiology,
2nd floor ,KLE Dr Prabhakar Kore hospital
Belgaum
KARNATAKA
590010
India |
| Phone |
9849481833 |
| Fax |
|
| Email |
ravichandreddy25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RAJESH S MANE |
| Designation |
Professor & Head |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
Department of Anaesthesiology
Belgaum
KARNATAKA
590010
India |
| Phone |
|
| Fax |
|
| Email |
drrajeshmane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RAVITEJA REDDY G S R N |
| Designation |
Post graduate |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
Department of Anaesthesiology
2nd floor
KLE Dr PRABHAKAR KORE HOSPITAL
Belgaum
KARNATAKA
590010
India |
| Phone |
|
| Fax |
|
| Email |
ravichandreddy25@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLES DR PRABHAKAR KORE HOSPITAL,JAWAHARLAL NEHRU MEDICAL COLLEGE |
|
|
Primary Sponsor
|
| Name |
RAVITEJA REDDY G S R N |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,JAWAHARLAL NEHRU MEDICAL COLLEGE, KLE UNIVERSITY CAMPUS NEHRU NAGAR , BELAGAVI,KARNATAKA |
| 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 RAVITEJA REDDY G S RN |
KLE DR PRABHAKAR KORE HOSPITAL |
Department of Anaesthesia
2nd floor
NEHRU NAGAR
Belgaum
KARNATAKA |
9849481833
ravichandreddy25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
nil |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound guided supraclavicular brachial plexus block in Conventional supine position. |
Patients lying in a supine position reclined at approximately 30 °. A pillow placed under the head, with the head turned away from the examination site. The distance from the pleura to the brachial plexus in this position will be measured. |
| Comparator Agent |
ultrasound guided supraclavicular brachial plexus block in lateral decubitus position |
Patients in lateral decubitus body position. In this position, the ipsilateral upper limb is rested comfortably in front of the chest wall. The shoulder joint will be adducted, and the humerus will be internally rotated .The distance from the pleura to the brachial plexus in this position will be measured. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age : 18yrs to 60yrs
ASA - I, II, and III
Elective upper limb surgeries
Patients who are willing to give consent
|
|
| ExclusionCriteria |
| Details |
ASA IV
BMI > 25 kg/m2
Coagulopathy
Infection at the injection site
Allergy to local anesthetic
Patients not willing to give informed consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the distance between pleura and brachial plexus in lateral decubitus and conventional supine positions using ultrasound. |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare block performance time, success rate of the block.
To study any other intra operative and postoperative complications.
|
baseline |
|
|
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)
|
01/03/2023 |
| 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="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
|
The Supraclavicular brachial plexus block is considered to be one of the most effective methods of anesthetic procedures in upper limb surgeries. Although ultrasound guidance has proven to be effective in improving the safety of supraclavicular brachial plexus block, the incidence of complications like pneumothorax has been reported to be as high as 0.5 to 5% with the conventional supine position technique. The change in body positions may improve the safety of performing ultrasound-guided supraclavicular brachial plexus block by reducing the incidence of the most common complication i.e. pneumothorax. |