| CTRI Number |
CTRI/2024/04/065368 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
06/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to compare the paralysis of diaphragm after giving regional anesthesia for upper limb surgeries via different approaches |
|
Scientific Title of Study
|
Comparison of Hemidiphragmatic paralysis in Supraclavicular versus Costoclavicular Block
A Prospective Controlled Study |
| 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 Sayantanee Roy |
| Designation |
Post graduate trainee |
| Affiliation |
Guwahati Medical College and Hospital |
| Address |
Department of Anesthesiology and Critical Care Guwahati Medical College and Hospital Guwahati Kamrup Metro
Kamrup
ASSAM
781032
India |
| Phone |
9365248716 |
| Fax |
|
| Email |
sayantanee1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Faiza Ahmed Talukdar |
| Designation |
Professor and Head of the Department |
| Affiliation |
Guwahati Medical College and Hospital |
| Address |
Department of Anesthesiology and Critical Care Guwahati Medical College and Hospital Guwahati Kamrup Metro
Kamrup
ASSAM
781032
India |
| Phone |
9864031429 |
| Fax |
|
| Email |
faizaahmedtalukdar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sayantanee Roy |
| Designation |
Post graduate trainee |
| Affiliation |
Guwahati Medical College and Hospital |
| Address |
Department pf Anesthesiology and Critical Care , Gauhati Medical College and Hospital Guwahati Kamrup Metro
Kamrup
ASSAM
781032
India |
| Phone |
9365248716 |
| Fax |
|
| Email |
sayantanee1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guwahati Medical College and Hospital Kamprup Metro - 781032 Assam |
|
|
Primary Sponsor
|
| Name |
Dr Sayantanee Roy |
| Address |
Department of Anesthesiology and Critical Care , Guwahati Medical College and Hospital, Bhangagarh , Guwahati.PIN - 781032 |
| 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 Sayantanee Roy |
Guwahati Medical College and Hospital |
Department of Anesthesiology and Critical Care , Guwahati Medical College and Hospital, Bhangagarh , Kamrup Metro-781032
Kamrup
ASSAM |
9365248716
sayantanee1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , Gauhati Medical College and Hospital |
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 |
| Intervention |
Costoclavicular Block using injection Ropivacaine |
Dose : 30 ml of 0.5% concentration of injection Ropivacaine.
Time of observation: After 30 minutes B-mode ultrasound examination of the ipsilateral hemidiaphragm will be performed to measure diaphragmatic excursion.
|
| Comparator Agent |
Supraclavicular block using injection Ropivacaine |
Dose : 30 ml of 0.5% concentration .
Time of observation:
After 30 minutes B-mode ultrasound examination of the ipsilateral hemidiaphragm will be performed to measure diaphragmatic excursion.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-60 years
ASA 1 and 2
Scheduled for elective orthopaedic upper limb surgery under supraclavicular brachial plexus block and costoclavicular brachial plexus block
Informed and written consent to participate in the study |
|
| ExclusionCriteria |
| Details |
Patients with known hypersensitivity to local anaesthetic agent
Infection at the site of block
Patient with known respiratory disorder
Patient whose pre operative SpO2 is less than 95%
Patients with known coagulopathy or on anti-coagulation therapy
Patients with diabetes mellitus
Pregnant and lactating mother
Morbid obesity
Patients on chronic analgesic therapy
Patients with peripheral vascular disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare the incidence of hemi diaphragmatic paralysis with supraclavicular and costoclavicular brachial plexus approach
|
Outcome will be assessed at 30 minutes after giving the block in the two groups . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the extent of diaphragmatic excursion between both groups
2. To check for side effects and complications
3.To compare the onset of block between two groups
4.To compare the duration of analgesia between two groups.
|
Outcome will be assessed at the following time intervals at rest :
0 hour , 3 minutes ,15 minutes ,30 minutes. |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
17/04/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study will be a prospective , randomised , double blinded , parallel group , single hospital , comparitive study , comparing the incidence of hemidiaphragmatic paralysis after giving supraclavicular versus costoclavicular block in upper limb surgeries. The null hypothesis is that there is no difference in between the study groups i.e. supraclavicular and costoclavicular block in terms of incidence of hemidiaphragmatic paralysis .
AIM : To compare the effect of supraclavicular versus costoclavicular block on diaphragmatic function.
PRIMARY OBJECTIVE : To compare the incidence of hemi diaphragmatic paralysis with supraclavicular versus costoclavicular brachial plexus approach.
SECONDARY OBJECTIVE : 1. To compare the extent of diaphragmatic excursion between both groups.
2. To check for side effects and complications 3. To compare the onset of block between the two groups 4. To compare the duration of analgesia between the two groups. |