| CTRI Number |
CTRI/2021/10/037456 [Registered on: 21/10/2021] Trial Registered Prospectively |
| Last Modified On: |
14/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON OF TWO DIFFERENT APPROACHES OF SUBCLAVIAN
PERIVASCULAR BRACHIAL PLEXUS BLOCK IN PATIENTS UNDERGOING
BELOW ELBOW SURGERIES |
|
Scientific Title of Study
|
“COMPARISON OF ULTRASOUND - GUIDED CONVENTIONAL (CORONAL
OBLIQUE) AND MODIFIED PARASAGITTAL APPROACH OF SUBCLAVIAN
PERIVASCULAR BRACHIAL PLEXUS BLOCK IN PATIENTS UNDERGOING
BELOW ELBOW SURGERIES – A RANDOMIZED PROSPECTIVE 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 Soundarya R |
| Designation |
Post Graduate Anaesthesiologist |
| Affiliation |
Ganga Medical Centre and Hospitals Pvt Ltd, Coimbatore, India |
| Address |
Ganga Medical Centre and Hospitals Pvt Ltd
313, Mettupalayam Road,
Coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
|
| Fax |
|
| Email |
soundarya4789@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C sekar |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Ganga Medical Centre and Hospitals Pvt Ltd, Coimbatore, India |
| Address |
Ganga Medical Centre and Hospitals Pvt Ltd
313, Mettupalayam Road,
Coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
|
| Fax |
|
| Email |
sekarchelliah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tuhin Mistry |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Ganga Medical Centre and Hospitals Pvt Ltd, Coimbatore, India |
| Address |
Ganga Medical Centre and Hospitals Pvt Ltd
313, Mettupalayam Road,
Coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
|
| Fax |
|
| Email |
tm.tuhin87@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ganga Medical Centre and Hospitals Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [None] |
|
|
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 |
| Soundarya R |
Ganga Hospital, Coimbatore |
313, Mettupalayam Road,
Coimbatore 641043.
Tamil Nadu, India.
Coimbatore
TAMIL NADU |
8939740190
soundarya4789@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Intitutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: S529||Unspecified fracture of forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brachial Plexus Block |
COMPARISON OF ULTRASOUND - GUIDED CONVENTIONAL (CORONAL OBLIQUE) AND MODIFIED PARASAGITTAL APPROACH OF SUBCLAVIAN PERIVASCULAR BRACHIAL PLEXUS BLOCK
Total duration 24 hours for follow up |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled for below-elbow (forearm and hand) surgeries (elective and
emergency) under SPBPB
Patients of either sex.
Age group between 18 and 60 years
Height 160–190 cm and weight 50–90 kg
Patients belonging to the American Society of Anaesthesiologists (ASA)
physical status grades I and II. |
|
| ExclusionCriteria |
| Details |
Patients not willing to participate in the study.
Patients with neurological deficit in the upper limb.
Body mass index (BMI) ≥30 kg/m2
Any contraindications to SPBPB like local skin pathology, bleeding disorder, or
patients on anticoagulants.
Conversion to general anaesthesia
Patients with a history of significant respiratory, cardiac, hepatic, renal,
neurological, or endocrinological diseases (ASA Class III or above).
Pregnant patients and lactating mothers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the ergonomics of two approaches (conventional and modified
parasagittal) in ultrasound-guided subclavian perivascular brachial plexus block in
terms of the time taken to optimize the ultrasound image (duration of scanning) and
time required to perform the block (duration of the procedure). |
During the performance of blocks and after the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare
1. Visibility of anatomical structures (pleura, first rib, sheath and elements of
brachial plexus, subclavian artery, transverse cervical or dorsal scapular artery)
2. Onset of sensory and motor blocks
3. Sparing of the nerve(s) between the two groups
4. Requirement for supplemental blocks between the two groups
5. Duration of the block
6. Comfort of the patient while performing the block
7. Complications (if any) |
during and after the block |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/11/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/11/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
BACKGROUND:
Supraclavicular block of the brachial plexus is a commonly used technique of
anaesthesia for upper limb surgeries. It provides an excellent anesthesia for the whole of
the upper limb often referred to as the spinal anaesthesia of the upper limb. The most
feared complication of this procedure is pneumothorax but with the advent of ultrasound
this has reduced. The conventional coronal approach as described by Chan et all of
ultrasound guided is the routinely being used technique wherein the apex of the lung is
visualized in close proximity to the plexus. Thus the risk of pneumothorax is still a feared
complication. Thus an ideal probe placement might improve better and safe visualization
of the brachial plexus in the supraclavicular region thereby decreasing the complication
with an improved execution of the block.
AIMS AND OBJECTIVES:
The study aims to compare the efficacy of ultrasound-guided conventional
technique (coronal oblique) with the modified parasagittal approach of subclavian
perivascular brachial plexus block in patients undergoing below elbow surgeries. The
primary objective is to compare the ergonomics of two approaches (conventional and
modified parasagittal) in ultrasound-guided subclavian perivascular brachial plexus block
in terms of the time taken to optimize the ultrasound image (duration of scanning) and
time required to perform the block (duration of the procedure). The secondary objectives
is to compare visibility of anatomical structures (pleura, first rib, sheath & elements of
brachial plexus, subclavian artery, transverse cervical/dorsal scapular artery), onset of
sensory and motor blocks, sparing of the nerve(s) between the two groups, requirement
for supplemental blocks between the two groups, duration of the block, comfort of the
patient while performing the block and complications (if any).
|