| CTRI Number |
CTRI/2018/12/016701 [Registered on: 18/12/2018] Trial Registered Retrospectively |
| Last Modified On: |
21/11/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effectiveness of a local anaesthetic(Ropivacaine) and the same drug with an adjuvant (Dexmedetomidine) as an anaesthesia technique given around nerve bundle above the collar bone for arm surgeries using ultrasound guidance |
|
Scientific Title of Study
|
Comparison of Ropivacaine and Ropivacaine with Dexmedetomidine in ultrasound guided supraclavicular brachial plexus block for upper limb surgeries- a double blinded, randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KEERTHI C |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Malankara Orthodox Syrian Church medical college,Kolenchery |
| Address |
Post graduate resident
Department of Anaesthesiology
Malankara Orthodox Syrian Church medical college
Kolenchery
Ernakulam
KERALA
682311
India |
| Phone |
9446392194 |
| Fax |
|
| Email |
keerthi.kausthubham@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anna Mathew |
| Designation |
Professor Research coordinator |
| Affiliation |
Malankara Orthodox Syrian Church medicl college Kolenchery |
| Address |
Department of Pharmacology Malankara Orthodox Syrian Church medical college Kolenchery
Ernakulam
KERALA
682311
India |
| Phone |
9442221950 |
| Fax |
2760409 |
| Email |
mosc.research@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anna Mathew |
| Designation |
Professor Research coordinator |
| Affiliation |
Malankara Orthodox Syrian Church medicl college Kolenchery |
| Address |
Department of Pharmacology Malankara Orthodox Syrian Church medical college Kolenchery
Ernakulam
KERALA
682311
India |
| Phone |
9442221950 |
| Fax |
2760409 |
| Email |
mosc.research@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology Malankara Orthodox Syrian Church medical college Kolenchery Ernakulam 682311 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Department of Anaesthesiology Malankara Orthodox Syrian Church medical college Kolenchery Ernakulam 682311 |
| Type of Sponsor |
Private 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 |
| Keerthi C |
Malankara Orthodox Syrian Church medical college |
Operation theatre
Department of Anaesthesiology
Ernakulam
KERALA |
9446392194
keerthi.kausthubham@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MOSC medical college ethics commitee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA 1 and 2 male and female between 18 to 70 years of age for upper limb surgeries below mid humerus. , (1) ICD-10 Condition: S50-S59||Injuries to the elbow and forearm, (2) ICD-10 Condition: S60-S69||Injuries to the wrist, hand and fingers, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group C |
Control group C will receive 29 ml 75 mg/ml Ropivacaine with 1 ml normal saline |
| Intervention |
Study group D |
Study group D will receive 29 ml Ropivacaine 75mg/ml with Dexmedetomidine 50 mcg made to 1 ml |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status 1 and 2, of either gender between 18 and 70 years of age for upper limb surgeries below mid humerus |
|
| ExclusionCriteria |
| Details |
morbid obesity, coagulopathy, uncontrolled diabetes mellitus, peripheral vascular disease, neurological disease, known allergy to local anaesthetics |
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dexmedetomidine added to Ropivacaine prolongs the duration of analgesia, in hastening and prolonging sensory and motor block when compared to Ropivacaine alone in supraclavicular brachial plexus block for upper limb surgeries |
Hemodynamic parameters,sensory and motor block, analgesia are assessed at 5, 10, 15, 20, 25, and 30 min and thereafter every 15 min for 1 hour till the block effect has resolved |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dexmedetomidine added to Ropivacaine is safer when compared to Ropivacaine alone in supraclavicular brachialplexus block for upper limb surgeries |
Adverse effects are assessed at 5, 10, 15, 20, 25, and 30 min and thereafter every 15 min for 1 hour till the block effect has resolved |
|
|
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" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2017 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
on completion of trial |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a double blinded randomized controlled trial to assess the efficacy of Dexmedetomidine as an adjuvant to Ropivacaine in ultrasound guided brachial plexus block for upper limb surgeries. Sample size was calculated by n- master software versiov 2.0. With power of 80% and alpha error of 5%, the sample size required is 30 in each group. To account for drop outs, the sample size was taken as 35 in each group. Randomisation was done by computer generated permuted block randomisation. Control group C (n= 35) will receive 29 ml 0.75% Ropivacaine+ 1 ml normal saline and study group D (n=35) will receive 29 ml 0.75% Ropivacaine+ Dexmedetomidine 50mcg( 0.5ml)+0.5 ml normal saline, to a total volume of30 ml in each group. Parameters assessed- onset of sensory block,duration of sensory block, onset of motor block, duration of motor block, duration of analgesia,hemodynamic parameters, sedation and adverse effects
|