| CTRI Number |
CTRI/2023/12/060933 [Registered on: 29/12/2023] Trial Registered Prospectively |
| Last Modified On: |
27/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
INFRACLAVICULAR BLOCK USING DEXMED AND DEXAMETHASONE TO ROPIVACAINE |
|
Scientific Title of Study
|
TO COMPARE THE ULTRASOUND GUIDED INFRACLAVICULAR BLOCK CHARACTERISTICS (ONSET & DURATION) USING DEXMEDETOMIDINE & DEXAMETHASONE AS ADJUVANTS TO ROPIVACAINE FOR UPPER LIMB SURGICAL INTERVENTIONS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kumar Ekant |
| Designation |
Post Graduate Trainee |
| Affiliation |
Armed Forces Medical College |
| Address |
Armed Forces Medical College, Southern Command, Solapur - Pune Hwy, near Race Course, Wanowrie, Pune, Maharashtra 411040 Pune
MAHARASHTRA
411040 India
Pune
MAHARASHTRA
411040
India |
| Phone |
7042577023 |
| Fax |
|
| Email |
dr.kr.ekant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Sud |
| Designation |
Associate Professor |
| Affiliation |
Armed forces medical college |
| Address |
Armed Forces Medical College, Southern Command, Solapur - Pune Hwy, near Race Course, Wanowrie, Pune, Maharashtra 411040 Pune
MAHARASHTRA
411040 India
Pune
MAHARASHTRA
411040
India |
| Phone |
6005709381 |
| Fax |
|
| Email |
Saurabhsood1975@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurabh Sud |
| Designation |
Associate Professor |
| Affiliation |
Armed forces medical college |
| Address |
Armed Forces Medical College, Dept of Anesthesia and critical care,Southern Command, Solapur - Pune Hwy, near Race Course, Wanowrie, Pune, Maharashtra 411040 Pune
MAHARASHTRA
411040 India
Pune
MAHARASHTRA
411040
India |
| Phone |
6005709381 |
| Fax |
|
| Email |
Saurabhsood1975@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Saurabh sud
Department of anaesthesiology and critical care
Armed Forces Medical College
southern command
solapur highway
wanowari
pune-40 |
|
|
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 |
| Dr Kumar ekant |
Armed forces medical college |
Armed forces medical college
Command Hospital ( SC)
Southern command,solapur-pune highway
Near race course,wanowrie
Maharashtra -411040
Pune
MAHARASHTRA |
7042577023
dr.kr.ekant@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Armed Forces Medical Colleg |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M20-M25||Other joint disorders, (2) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparing two adjuvants Dexamethasone and dexmedetomidine with Ropivacaine in usg guided infraclavicular block |
The onset duration of sensory and motor blockade, along with analgesia, will be meticulously compared between two different adjuvants ie-Dexamethasone and dexmedetomidine with a local anesthetic ( ropivacaine ) used in an infraclavicular block during upper limb surgeries. |
| Intervention |
Infraclavicular block using Local anesthetic under usg guidance |
Comparing the effects( Onset and duration of sensory and motor blockage as well as analgesia )in ultrasound-guided Infraclavicular block using Ropivacaine with adjuvants such as dexmedetomidine and Dexamethasone in two different groups
Duration of block to effect will be monitored for 30 minutes,intraop every 15 minutes, post op every 2 hourly till next 24 hours or till regression of block effect |
|
|
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 of humerus
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. |
Initially, every 3 min till full blockage is achieved then every 30 minutes for the first 2 hrs then every 2 hours in postop for 24 hrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intraoperative monitoring of vitals (pulse rate, blood pressure, O2 saturation and
adverse effect if any), duration of analgesia, complications (if any) along with supplemented analgesia
|
every 15 min |
|
|
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 1 |
|
Date of First Enrollment (India)
|
30/01/2024 |
| 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 characteristics for 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 ropivacaine with two adjuvents and see that which drug combination has early motor and sensory blockage and provides good analgesia. Earlier that has been studies with ropivacaine with single adjuvant but no studies has been done comparing two adjunants so we will be doing comparative study for better results |