| CTRI Number |
CTRI/2023/08/056564 [Registered on: 16/08/2023] Trial Registered Prospectively |
| Last Modified On: |
19/08/2023 |
| 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 incidence of weakness of same side diaphragm following two different approaches of brachial plexus block. |
|
Scientific Title of Study
|
Comparison of incidence of ipsilateral hemidiaphragmatic paresis following supraclavicular and costoclavicular approach to 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 Jatin Lal |
| Designation |
Professor |
| Affiliation |
PT.B.D.Sharma PGIMS Rohtak |
| Address |
Dept. of Anaesthesiology,2nd floor, Modular OT complex, Pt. B. D. Sharma PGIMS, Rohtak.
Rohtak
HARYANA
124001
India |
| Phone |
9728265511 |
| Fax |
|
| Email |
dr.jatinlal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jatin Lal |
| Designation |
Professor |
| Affiliation |
PT.B.D.Sharma PGIMS Rohtak |
| Address |
Dept. of Anaesthesiology,2nd floor, Modular OT complex, Pt. B. D. Sharma PGIMS, Rohtak.
HARYANA
124001
India |
| Phone |
9728265511 |
| Fax |
|
| Email |
dr.jatinlal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Gowrishankar |
| Designation |
Junior resident |
| Affiliation |
Pt B D Sharma PGIMS, Rohtak |
| Address |
Dept. of Anaesthesiology, 2nd Floor, Modular OT complex, Pt.B.D.Sharma PGIMS,Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
6382456683 |
| Fax |
|
| Email |
gowrishankarsubramani46556@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. of Anaesthesiology, Pt. B. D. Sharma PGIMS, Rohtak. |
|
|
Primary Sponsor
|
| Name |
Pt B D Sharma PGIMS Rohtak |
| Address |
Dept of Anaesthesiology and Critical Care,Pt. B. D. Sharma PGIMS, Medical Road, Rohtak 124001 Haryana |
| 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 |
| Dr Jatin Lal |
Pt. B. D. Sharma PGIMS, Rohtak. |
Dept. of Anaesthesiology, 2nd Floor, Modular OT Complex.
Rohtak
HARYANA |
9728265511
dr.jatinlal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research 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 |
Ultrasound guided costoclavicular brachial plexus block. |
Patient will be administered ultrasound guided costoclavicular brachial plexus block for elective surgery below midarm. Incidence of ipsilateral hemidiapragmatic paresis will be noted. |
| Intervention |
Ultrasound guided supraclavicular brachial plexus block. |
Patient will be administered ultrasound guided supraclavicular brachial plexus block for elective surgery below midarm. Incidence of ipsilateral hemidiapragmatic paresis will be noted. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having American Society of Anesthesiologists (ASA) grade I-III, scheduled to undergo elective surgery below midarm of less than 2 hours duration, under regional anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patients with
-Significant pulmonary disease
-History of psychiatric illness.
-Diabetes mellitus, neuropathy, patients receiving opioids for chronic pain therapy
-Known coagulopathy or on anticoagulant therapy.
-Infection at the injection site.
-Pregnant and lactating female patients.
-Hypersensitivity to local anesthetic drug used.
-Patient refusal and inability to give informed consent.
will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| USG assessment of ipsilateral hemidiaphragmatic excursion. |
-Before performing supraclavicular/costoclavicular approach to brachial plexus block.
- 30 min after performing supraclavicular/costoclavicular approach to brachial plexus block. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of sensory block |
-5 minutes after giving block
-10 minutes after giving block
-15 minutes after giving block
-20 minutes after giving block
-25 minutes after giving block
-30 minutes after giving block |
| Assessment of Motor block |
-5 minutes after giving block
-10 minutes after giving block
-15 minutes after giving block
-20 minutes after giving block
-25 minutes after giving block
-30 minutes after giving block |
| Patient satisfaction using visual analogue scale (VAS) |
- Immediately after performing block
- After the completion of surgery |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2023 |
| Date of Study Completion (India) |
02/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This study will
be conducted in the Department of Anaesthesiology and Critical care, Pt. B.D. Sharma
PGIMS , Rohtak. Fifty patients of either sex, 18-70 years old, ASA grade I-III,
scheduled to undergo elective surgeries below mid arm will be enrolled for the
study. The aim of this study is to compare the incidence of hemidiaphragmatic
paresis following supraclavicular and costoclavicular approach to brachial
plexus block. The primary objective is to compare the incidence of
hemidiaphragmatic paresis between supraclavicular and costoclavicular approach
to brachial plexus block using ultrasonographic assessment of ipsilateral
hemidiaphragmatic excursion. The secondary objectives are to compare the
efficacy of both the blocks and patient satisfaction.
|