| CTRI Number |
CTRI/2021/10/037274 [Registered on: 12/10/2021] Trial Registered Prospectively |
| Last Modified On: |
10/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARITIVE STUDY BETWEEN DEXMEDETOMEDINE AND BUPRENORPHINE AS AN ADJUVANT TO ROPIVACAINE 0.5% IN ULTRASOUND GUIDED SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK FOR UPPER LIMB ORTHOPEDIC SURGERIES |
|
Scientific Title of Study
|
A PROSPECTIVE RANDOMIZED, COMPARITIVE STUDY BETWEEN DEXMEDETOMEDINE AND BUPRENORPHINE AS AN ADJUVANT TO ROPIVACAINE 0.5% IN ULTRASOUND GUIDED SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK FOR UPPER LIMB ORTHOPEDIC SURGERIES |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sangeetha C |
| Designation |
Assistant Professor |
| Affiliation |
Sanjay Gandhi Institute of Trauma And Orthopedics |
| Address |
Department of Anesthesia
Sanjay Gandhi Institute Of Trauma And Orthopedics Byrasandra Jayanagar Bengaluru
Sanjay Gandhi Institute Of Trauma And Orthopedics Byrasandra Jayanagar Bengaluru
Bangalore
KARNATAKA
560011
India |
| Phone |
9886623479 |
| Fax |
|
| Email |
sangudaya.sd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangeetha C |
| Designation |
Assistant Professor |
| Affiliation |
Sanjay Gandhi Institute of Trauma And Orthopedics |
| Address |
Department of Anesthesia
Sanjay Gandhi Institute Of Trauma And Orthopedics Byrasandra Jayanagar Bengaluru
Sanjay Gandhi Institute Of Trauma And Orthopedics Byrasandra Jayanagar Bengaluru
Bangalore
KARNATAKA
560011
India |
| Phone |
9886623479 |
| Fax |
|
| Email |
sangudaya.sd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sangeetha C |
| Designation |
Assistant Professor |
| Affiliation |
Sanjay Gandhi Institute of Trauma And Orthopedics |
| Address |
Department of Anesthesia
Sanjay Gandhi Institute Of Trauma And Orthopedics Byrasandra Jayanagar Bengaluru
Sanjay Gandhi Institute Of Trauma And Orthopedics Byrasandra Jayanagar Bengaluru
Bangalore
KARNATAKA
560011
India |
| Phone |
9886623479 |
| Fax |
|
| Email |
sangudaya.sd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Institute Of Trauma And Orthopedics |
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi Institute Of Trauma And Orthopedics |
| Address |
Sanjay Gandhi Institute Of Trauma And Orthopedics, Byrasandra, Jayanagar, Bengaluru |
| 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 Sangeetha C |
Major operation theater Sanjay Gandhi Institute of Trauma and Orthopedics |
Sanjay Gandhi Institute Of Trauma And Orthopedics Byrasandra jayanagar Bengaluru
Bangalore
KARNATAKA |
9886623479
sangudaya.sd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Sanjay Gandhi Institute Of Trauma And Orthopaedics |
Approved |
| Sanjay Gandhi institute Of Trauma And Orthopedics |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S521||Fracture of upper end of radius, (2) ICD-10 Condition: S520||Fracture of upper end of ulna, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
buprenorphine |
buprenorphine 3mcg/kg at the time of block administration |
| Comparator Agent |
dexmedetomidine |
dexmedetomidine 1mcg/kg at the time of block administration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 18 to 60 years admitted for elective upperlimb orthopaedic surgeries in Sanjay Gandhi Institute Of Trauma And Orthopaedics,Bengaluru
|
|
| ExclusionCriteria |
| Details |
History of neurological, psychiatric, neuromuscular,alcoholism or drug abuse and patients receiving adrenoceptor agonist or antagonist therapy.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| time of onset of sensory block and duration of analgesia |
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| any adverse effects |
1 day |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
21/10/2021 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
.Supraclavicular block is a regional anaesthetic technique used as an alternative or adjunct to general anesthesia or used for postoperative pain control for upper extremity surgeries (mid-humerus through the hand). Various adjuvants have been added to local anesthetics to increase the efficacy and duration of blocks,minimizing systemic adverse effects along with a reduction in the total dose of local anesthetic used. Dexmedetomidine, a potent α2 adrenocepter agonist ,has been reported to improve the quality of intrathecal and epidural anesthesia.(1,2,3) Its use in peripheral nerve blocks has recently been described. Buprenorphine is lipophilic opioid with high molecular weight and having high affinity for μ receptors, has a longer duration of action,and is easily available, cost-effective and hence selected for this study Ropivacaine has a long duration of action, with similar pharmacology to bupivacaine but a wider safety margin In this study, we will investigate whether adding dexmedetomidine or buprenorphine to 0.5%ropivacaine for supraclavicular brachial plexus block would affect the sensory and motor blocks and duration of analgesia |