| CTRI Number |
CTRI/2022/11/047386 [Registered on: 17/11/2022] Trial Registered Prospectively |
| Last Modified On: |
16/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The study is to evaluate tramadol ,dexmedetomedine and clonidine as an adjuvant to levobupivacaine in supraclavicular brachial plexus block |
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Scientific Title of Study
|
COMPARISON OF TRAMADOL, DEXMEDETOMIDINE AND CLONIDINE AS ADJUVANT TO LEVO BUPIVACAINE FOR SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK FOR UPPER LIMB SURGERY UNDER USG GUIDANCE
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| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swati Singhal |
| Designation |
Resident doctor |
| Affiliation |
Jaipur national university institute of medical science and research centre |
| Address |
Operation theater, anesthesia department, Jaipur national university institute of medical science and research centre, near RTO OFFICE JAGATPURA JAIPUR
Jaipur
RAJASTHAN
302017
India |
| Phone |
9993613033 |
| Fax |
|
| Email |
drswatilokeshsinghal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Singhal |
| Designation |
Resident doctor |
| Affiliation |
Jaipur national university institute of medical science and research centre |
| Address |
pg hostel , anesthesia department, Jaipur national university institute of medical science and research centre, near RTO OFFICE JAGATPURA JAIPUR
Jaipur
RAJASTHAN
302017
India |
| Phone |
9993613033 |
| Fax |
|
| Email |
drswatilokeshsinghal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Singhal |
| Designation |
Resident doctor |
| Affiliation |
Jaipur national university institute of medical science and research centre |
| Address |
Pg hostel, anesthesia department, Jaipur national university institute of medical science and research centre, near RTO OFFICE JAGATPURA JAIPUR
Jaipur
RAJASTHAN
302017
India |
| Phone |
9993613033 |
| Fax |
|
| Email |
drswatilokeshsinghal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jaipur national university institute of medical science and research centre ,rto office jagatpura jaipur |
|
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Primary Sponsor
|
| Name |
Jnu hospital |
| Address |
JNUIMSRC near rto office jagatpura jaipur |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S P Sharma |
JNUIMSRC |
Operation theater, anesthesia department, Jaipur national university institute of medical science and research centre, near RTO office jagatpura jaipur
Jaipur
RAJASTHAN |
9414293768
spsharmadr@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central research committee and institutional ethics committee of JNUIMSRC |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: 8||Other Procedures, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clonidine, Tramadol and dexmedetomedine |
Comparison of 100 mg Tramadol ,or 1 ug / kg clonidine or 1ug/kg dexmedetomedine as an adjuvant to 0.5% levobupivacaine in ultrasound guided supraclavicular block for upper arm surgery |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patient who giving informed consent |
|
| ExclusionCriteria |
| Details |
Patients with previous history or clinical presentation with central or peripheral neurological disease, coagulopathy, infection at the site of injection, patient allergic to any of the study drugs and those unable to co-operate will be excluded from the study. |
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
Duration of analgesic
Intraoperative hemodynamic monitoring |
Ramsay scale every 15 min interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effect of three drugs .
• Hemodynamic responses
• Onset of sensory blockade and motor blockade
• Duration of sensory and motor blockade
• To compare post operative pain levels.
• Complications / side effects if any
|
Every 15 min during operation and afer shifting to ward |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/11/2022 |
| 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
|
Not yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is to evaluate tramadol ,dexmedetomedine and clonidine as an adjuvant to levobupivacaine in supraclavicular brachial plexus block in terms of
• Hemodynamic responses
• Onset of sensory blockade and motor blockade
• Duration of sensory and motor blockade
• To compare post operative pain levels.
• Complications / side effects if any
|