| CTRI Number |
CTRI/2020/05/025249 [Registered on: 20/05/2020] Trial Registered Prospectively |
| Last Modified On: |
20/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of 2 different doses of dexmedatomidine with 0.5 percent levobpivacaine for post operative analgesia |
|
Scientific Title of Study
|
"Comparison of two different doses of Dexmedetomidine combined with 0.5 % Levobupivacaine for post operative analgesia in ultrasound guided supraclavicular brachial plexus block-A double blinded randomized cantrolled study" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KOTHAMASU SOMBABU |
| Designation |
POST GRADUATE |
| Affiliation |
CHETTINAD HOSPITAL AND REASERCH INSTITUTE |
| Address |
Flat no-303,A block,
Purva Swan Lake Appartments,
keelambakkam,
Chennai
Department of Anesthesia and Critical Care
Chettinad Hospital and Reaserch institute
keelambakkam,Chennai
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9952059987 |
| Fax |
|
| Email |
drsom1988@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ASHOK KULASEKHAR |
| Designation |
Professor |
| Affiliation |
CHETTINAD HOSPITAL AND REASERCH INSTITUTE |
| Address |
Department of Anesthesia and Critical Care
Chettinad Hospital and Reaserch institute
keelambakkam,Chennai
Department of Anesthesia and Critical Care
Chettinad Hospital and Reaserch institute
keelambakkam,Chennai
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9003216741 |
| Fax |
|
| Email |
ashokk_dr1@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
KOTHAMASU SOMBABU |
| Designation |
POST GRADUATE |
| Affiliation |
CHETTINAD HOSPITAL AND REASERCH INSTITUTE |
| Address |
Department of Anesthesia and Critical Care
Chettinad Hospital and Reaserch institute
keelambakkam,Chennai
Department of Anesthesia and Critical Care
Chettinad Hospital and Reaserch institute
keelambakkam,Chennai
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9952059987 |
| Fax |
|
| Email |
drsom1988@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIA
CHETTINAD HOSPITAL and Research Institute,OMR,KELAMBAKKAM,
CHENNAI,TAMILNADU,INDIA |
|
|
Primary Sponsor
|
| Name |
CHETTINAD HOSPITAL AND REASERCH INSTITUTE |
| Address |
CHETTINAD HOSPITAL AND REASERCH INSTITUTE
KEELAMBAKKAM,CHENNAI |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrASHOK KULASEKHAR |
Chettinad hospital and research institute |
D block ICU complex IInd floor Dept of Anaesthesiology
Chettinad Hospital and Research Institute Kelambakkam Chennai
Kancheepuram
TAMIL NADU |
9840498420
ashokk_dr@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: S598||Other specified injuries of elbowand forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.5% Levobipivacaine with 75 micrograms of dexmedatomidine |
Group LD 75 patients receieve 70 micrograms of dexmedatomidine combined with 0.5 percent levobupivacaine total volume to be injected is 30 ml using ultrasoung into brachial plexus |
| Intervention |
0/5% levobupivacaine with 50 microgram of dexmedatomidine |
Group LD 50 patients receieve 50 micrograms of dexmedatomidine combined with 0.5 percent levobupivacaine total volume to be injected is 30 ml using ultrasoung into brachial plexus |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All ASA-1 AND ASA-2 patients undergoing either elective or emergency upperlimb surgical procedure |
|
| ExclusionCriteria |
| Details |
Pediatric patients
Geriatric patients(age more than 70 years)
Patients with known comorbities(diabetes,hypertension,asthma,seizure disorder,hypothyroidism)
patients who are allergic to local anaesthetic drugs
Patients who are not not willing for surgical procedure under regional anaesthesia
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| every 30 min till the onset of pain |
every 30 min after injecting drug till the onset of pain |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
effect on hemodynamics
onset and duration of of sensory and motor blokade |
From the 0 min till 30 min whn patient complains of pain |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
20/05/2020 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients who are posted for elective and emergency upperlimb procedures Patients who are classified under american society of anaesthesiologists,who comes under ASA-1 and ASA-2 For elective surgeries adequate NPO status of six hours is maintained preoperatively T.Dizepam 5mg and T.Rantac150 mg is given preoperative night before surgery For emergency procedure NPO status of six hours is followed A total number of 56 patients are allocated randomly using computer generated code,Group 50 receives 29 ml of 0.5% levobupivacaine groupD75 recieves 75 microgram of dexmedatomidine and 29 ml of 0.5 percent levobupivacaine Motor onset and sensory onset are recorded Surgeries done only under block Intraoperative and post operative hemodynamic variables are recorded for each patient Patient shifted to surgical ICU after the procedure and post operatively patient is monitored If patient have VAS score more than 3/10 then rescue analgesia is given with tramadol 100 mg |