| CTRI Number |
CTRI/2024/02/062687 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
12/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
comparing ultrasound guided infraclavicular block using Dexmedomitidine as adjuvants to Ropivacaine(0.375%) and Levobupivacaine (0.25%) for upper limb surgical interventions. |
|
Scientific Title of Study
|
To compare ultrasound guided infraclavicular block characterstics using dexmedomitidine as adjuvant to ropivacaine and levobupivacaine for upper limb surgical intervention |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAURABH SUD |
| Designation |
ASSOC PROF |
| Affiliation |
ARMED FORCES MEDICAL COLLEGE |
| Address |
Armed Forces Medical College, Southern Command, Solapur - PuneHwy, near Race Course, Wanowrie, Pune, Maharashtra 411040 PuneMAHARASHTRA 411040 India
Pune
MAHARASHTRA
411040
India |
| Phone |
6005709381 |
| Fax |
|
| Email |
Saurabhsood1975@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SAURABH SUD |
| Designation |
ASSOC PROF |
| Affiliation |
ARMED FORCES MEDICAL COLLEGE |
| Address |
Armed Forces Medical College, Southern Command, Solapur - PuneHwy, near Race Course, Wanowrie, Pune, Maharashtra 411040 PuneMAHARASHTRA 411040 India
Pune
MAHARASHTRA
411040
India |
| Phone |
6005709381 |
| Fax |
|
| Email |
Saurabhsood1975@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SAURABH SUD |
| Designation |
ASSOC PROF |
| Affiliation |
ARMED FORCES MEDICAL COLLEGE |
| Address |
Armed Forces Medical College, Southern Command, Solapur - PuneHwy, near Race Course, Wanowrie, Pune, Maharashtra 411040 PuneMAHARASHTRA 411040 India
Pune
MAHARASHTRA
411040
India |
| Phone |
6005709381 |
| Fax |
|
| Email |
Saurabhsood1975@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology and critical care Armed Forces Medical College |
|
|
Primary Sponsor
|
| Name |
Armed forces medical college, Pune |
| Address |
Southern Command, Solapur - Pune Hwy, near Race Course,Wanowrie, Pune, Maharashtra 411040 |
| 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 |
| SAURABH SUD |
ARMED FORCES MEDICAL COLLEGE |
Armed forces medical collegeSouthern command,solapur-pune highway Near racecourse,wanowrie Maharashtra-411040
Pune
MAHARASHTRA
Parbhani
MAHARASHTRA |
6005709381
Saurabhsood1975@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE ARMED FORCES MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparing Dexmedomitidine as adjuvants to Ropivacaine and Levobupivacaine |
Comparing the onset duration of sensory and motor blockade as well as analgesia when performing infraclavicular block in upper limb surgeries |
| Intervention |
Infraclavicular block using Dexmedomitidine as adjuvants to Ropivacaine(0.375%) and Levobupivacaine (0.25%) |
Comparing the effects( Onset andduration of sensory and motor blockageas well as analgesia )in ultrasound guidedInfraclavicular block using Dexmedomitidine as adjuvants to Ropivacaine(0.375%) and Levobupivacaine (0.25%)in two different groups |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade I, II, III, IV
2. Age 18- 60years
3. Patients listed for surgical intervention in upper limb
4. Written informed consent of patient for the study |
|
| ExclusionCriteria |
| Details |
1. Age < 18 and > 60 years
2. History of allergy to local anesthetic drugs being used in the block
3. Presence of any neurological deficit in the involved limb
4. Fractures involving clavicle, shoulder region and upper 1/3 rd ofhumerus
5. Local site infection
6. Any structural deformity of the injection site
7. History of coagulopathy or patients using anticoagulants
8. Peripheral vascular disease
9. Block which failed and converted to other Anaesthesia technique |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset and duration of sensory and motor blockage as well as analgesia |
Onset and duration of sensory and motor blockage as well as analgesia
initially, every 3 minutes till the full motor and sensory block is achieved, then postop every hour until 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intraoperative monitoring of vitals (pulse rate, blood pressure, O2saturation and
adverse effect if any), duration of analgesia, complications (if any) along with supplemented analgesia |
every 15 min intraop then every 30 min for first 90 min then 2 hourly |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2024 |
| 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="6"
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
|
The study is about comparing ultrasound guided infra clavicular block characteristicsfor upper Limb surgical intervention which will be performed in the patients who are admitted to this hospital and required a surgical intervention in the upper limb we will be comparing dexmedetomidine with Ropivacaine(0.375%) and Levobupivacaine (0.25%) and see that which drug combination has early motor and sensory blockage and provides good analgesia.
|