| CTRI Number |
CTRI/2021/04/032594 [Registered on: 07/04/2021] Trial Registered Prospectively |
| Last Modified On: |
06/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of effects with dexmedetomidine and dexamethasone as an adjuvant to bupivacaine in supraclavicular block in adult patients undergoing forearm and hand surgeries |
|
Scientific Title of Study
|
Comparison of sensory and motor block characteristics with dexmedetomidine and dexamethasone as an adjuvant to bupivacaine in supraclavicular block in adult patients undergoing forearm and hand surgeries |
| Trial Acronym |
SCBDD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramanaathan L |
| Designation |
Post graduate student |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of anaesthesiology
VMMC and Safdarjung Hospital
New Delhi
DELHI
110029
India |
| Phone |
8122728546 |
| Fax |
|
| Email |
ram6nath55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PAVAN NAYAR |
| Designation |
CONSULTANT AND PROFESSOR |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
VMMC AND SAFDARJUNG HOSPITAL
New Delhi
DELHI
110029
India |
| Phone |
9971935269 |
| Fax |
|
| Email |
pavannayar1957@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramanaathan L |
| Designation |
Post graduate student |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
VMMC and Safdarjung Hospital
New Delhi
DELHI
110029
India |
| Phone |
8122728546 |
| Fax |
|
| Email |
ram6nath55@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC AND SAFDARJUNG HOSPITAL |
|
|
Primary Sponsor
|
| Name |
VMMC Safdarjung hospital |
| Address |
new delhi |
| 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 RAMANAATHAN L |
VMMC &Safdarjung hospital |
department of anaesthesiology vmmc and safdarjung hospital
ANSARI NAGAR
New Delhi
DELHI |
8122728546
ram6nath55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VMMC institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S62||Fracture at wrist and hand level, (2) ICD-10 Condition: T23||Burn and corrosion of wrist and hand, (3) ICD-10 Condition: T79A||Traumatic compartment syndrome, (4) ICD-10 Condition: S52||Fracture of forearm, (5) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DEXAMETHASONE AS AN ADJUVANT TO BUPIVACAINE IN SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK.
ROUTE OF ADMINISTRATION :PERINEURAL BLOCK |
18ml OF 0.5% BUPIVACAINE + 8mg DEXAMETHASONE GIVEN IN SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK.
ONSET AND DURATION OF SENSORY BLOCK.ONSET AND DURATION OF MOTOR BLOCK,TIME TO RESCUE ANALGESIC WILL BE ASSESSED |
| Comparator Agent |
DEXMEDETOMIDINE AS AN ADJUVANT TO BUPIVACAINE IN SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK.
ROUTE OF ADMINISTRATION : PERINEURAL BLOCK |
18ml OF O.5% BUPIVACAINE + 50mcg OF DEXMEDETOMIDINE + 1ml NS
GIVEN IN SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK
ONSET AND DURATION OF SENSORY BLOCK,ONSET AND DURATION OF MOTOR BLOCK,TIME TO RESCUE ANALGESICS WILL BE ASSESSED |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists grade l and ll patients undergoing forearm and hand surgeries |
|
| ExclusionCriteria |
| Details |
Known allergy to study drugs,pregnancy and lactation,patients with pre-existing peripheral neuropathy and coagulation disorders,infection at site of injection,patients on beta blockers and anti-hypertensive therapy |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| onset and duration of sensory and motor block when dexmedetomidine or dexamethasone are used as an adjuvant to bupivacaine in supraclavicular brachial plexus block in adult patients undergoing forearm and hand surgeries |
onset of sensory and motor block will be assessed once in every minute
duration of sensory and motor block will be assessed once in an hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| intraoperative hemodynamic changes |
5mins,10mins,15mins,30mins,45mins,1hour,1hour 30mins,2hours,2hour s30mins,3hours |
| time to first rescue analgesia |
hourly assessment |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
07/04/2021 |
| 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 Applicable |
| 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
|
TITLE : COMPARISON OF SENSORY AND MOTOR BLOCK CHARACTERISTICS WITH DEXMEDETOMIDINE AND DEXAMETHASONE AS AN ADJUVANT TO BUPIVACAINE IN SUPRACLAVICULAR BLOCK IN ADULT PATIENTS UNDERGOING FOREARM AND HAND SURGERIES STUDY DESIGN : PROSPECTIVE INTERVENTIONAL RANDOMIZED COMPARATIVE STUDY VENUE OF STUDY : VMMC AND SAFDARJUNG HOSPITAL SAMPLE SIZE : 80 PATIENTS CATEGORIZED INTO TWO GROUPS BY BLOCK RANDOMIZATION GROUP A WILL BE GIVEN 18ml OF 0.5% BUPIVACAINE AND 50 mcg OF DEXMEDETOMIDINE GROUP B WILL BE GIVEN 18ml OF 0.5% BUPIVACAINE AND 8mg OF DEXAMETHASONE IN SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK USING PERIPHERAL NERVE STIMULATOR PRIMARY OBJECTIVE : TO EVALUATE ONSET AND DURATION OF SENSORY AND MOTOR BLOCK WITH DEXMEDETOMIDINE OR DEXAMETHASONE ARE USED AS AN ADJUVANT TO BUPIVACAINE IN SUPRACLAVICULAR BLOCK SECONDARY OBJECTIVE : TO OBSERVE INTRAOPERATIVE HEMODYNAMIC CHANGES TIME TO FIRST RESCUE ANALGESIC
|