| CTRI Number |
CTRI/2019/01/017082 [Registered on: 15/01/2019] Trial Registered Prospectively |
| Last Modified On: |
25/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
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Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Active Controlled Trial |
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Public Title of Study
|
comparision of efficacy of two medicines(dexmeditomidine and dexamethasone) when used with another medicine(ropivacaine)when given as injections at side of neck,surrounding the nerves of shoulder joint as pain relief measure during shoulder surgeries done through surgical instrument(arthroscope) |
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Scientific Title of Study
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“ Comparison Of Ultrasound Guided Interscalene Brachial Plexus Block For Arthroscopic Shoulder Surgeries Using 0.2% Ropivacaine With Dexmeditomidine And 0.2% Ropivacaine With Dexamethasone – A Prospective Observational Study’ |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manasa S |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College ,Manipal |
| Address |
Department of Anaesthesiology
Kasturba Medical College
Manipal,Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9591211323 |
| Fax |
|
| Email |
manassubindu28@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Shaji Mathew |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College ,Manipal |
| Address |
Department of Anaesthesiology
Kasturba Medical College
Manipal,Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9449388791 |
| Fax |
|
| Email |
shajimanipal@yahoo.co.in |
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Details of Contact Person
Public Query
|
| Name |
Dr Shiyad |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College ,Manipal |
| Address |
Department of Anaesthesiology
Kasturba Medical College
Manipal,Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9483273635 |
| Fax |
|
| Email |
shiyad82@gmail.com |
|
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Source of Monetary or Material Support
|
| DR MANASA S
JUNIOR RESIDENT
DEPT OF ANAESTHESIOLOGY,
KMC MANIPAL |
|
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Primary Sponsor
|
| Name |
Dr Manasa S |
| Address |
Department of anaesthesiology kasturba medical college manipal |
| Type of Sponsor |
Other [SELF] |
|
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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 MANASA S |
KASTURBA MEDICAL COLLEGE ,MANIPAL |
KASTURBA MEDICAL COLLEGE ,MANIPAL
Udupi
KARNATAKA |
9591211323
manassubindu28@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,KASTURBA MEDICAL COLLEGE ,MANIPAL |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S433||Subluxation and dislocation of other and unspecified parts of shoulder girdle, |
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Intervention / Comparator Agent
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anaesthesiologist physical status 1 or 2,
patients undergoing elective arthroscopic shoulder surgery under interscalene blockwith 0.2% ropivacaine+1microgram/kg of dexmeditomidine or 100 microgram/kg of dexamethasone+General Anaesthesi as per standard protocol |
|
| ExclusionCriteria |
| Details |
patient refusal,bleeding disorders,local infections,pregnsnt women,local anaesthetics allergy,seizure disorders |
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
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Blinding/Masking
|
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Primary Outcome
|
| Outcome |
TimePoints |
| duration of sensory and motor blockade |
duration of sensory and motor blockade |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| need for rescue analgesia |
IN POST OPERATIVE PERIOD ,WITHIN 24HOURS |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="92" |
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Phase of Trial
|
Phase 4 |
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Date of First Enrollment (India)
|
15/01/2019 |
| Date of Study Completion (India) |
12/09/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
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Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
NONE YET |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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Addition of adjuvant (opioids or non-opioids) with local anaesthetics in brachial plexus block is aimed at quicker onset, enhanced quality and duration of blockade. Dexmedetomidine is a selective alpha-2 adrenoreceptor agonist and Dexamethasone is a glucocorticoid.Studies prove that, both the drugs when added to local anaesthetics in regional nerve blocks ,they shorten the onset of action of block, prolong the duration of motor and sensory block as well as analgesia. It’s a known fact that dexmedetomidine causes bradycardia and hypotension when used in the dose of 1 to 1.5 microgram per kg, which can be very difficult to treat. Also dexmedetomidine is comparatively costlier than dexamethasone. But many previous studies done so far have shown that dexmedetomidine is very effective as an analgesic and also significantly prolongs the duration of sensory blockade when used as an adjuvant with local anaesthetics for peripheral nerve blocks. Hence this study is been done to compare the efficacy of dexmedetomidine and dexamethasone as adjuvants with 0.2% ropivacaine in arthroscopic shoulder surgeries. Detailed description of procedure / processes: All patients will be seen the day prior to surgery, assessed for suitability of inclusion in study. Informed consent will be taken. They will be premedicated and Standard guidelines for fasting will be followed. On the day of surgery, in the operation theatre, a suitable intravenous access will be obtained. Monitoring with pulse oximetry, noninvasive blood pressure monitor and five-lead electrocardiography will be commenced and note the baseline values. The patient will reassessed by consultant anaesthesiologist and he/she will administer ultrasound guided Interscalene block as per standard protocol in the department with the additive of his/her choice (either Dexmeditomedine or Dexamethasone). The onset and duration of sensory loss and motor blockade will be noted. Pre-operative, intra-operative and post-operative data will be collected and analyzed in the study. No other intervention will be done.
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