| CTRI Number |
CTRI/2019/01/017309 [Registered on: 31/01/2019] Trial Registered Prospectively |
| Last Modified On: |
15/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between 0.5% Ropivacaine and in combination with Dexmedetomidine for ultrasound guided Supraclavicular brachial plexus block for upper limb surgery. |
|
Scientific Title of Study
|
A study to compare the anaesthetic properties of 0.5% Ropivacaine alone and in combination with Dexmedetomidine for ultrasound guided Supraclavicular brachial plexus block in patients undergoing upper limb surgery. |
| Trial Acronym |
SCBPB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vikas Gupta |
| Designation |
Postgraduate student |
| Affiliation |
Jawahar lal nehru medical college, ajmer, rajasthan |
| Address |
Department of anaesthesiology, JLN medical college, ajmer, rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
9694941940 |
| Fax |
|
| Email |
vickybtp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Jain |
| Designation |
Senior Professor and guide |
| Affiliation |
Jawahar lal nehru medical college, ajmer, rajasthan |
| Address |
Department of anaesthesiology, JLN medical college, ajmer, rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
|
| Fax |
|
| Email |
drkavitajain15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita Jain |
| Designation |
Senior Professor and guide |
| Affiliation |
Jawahar lal nehru medical college, ajmer, rajasthan |
| Address |
Department of anaesthesiology, JLN medical college, ajmer, rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
|
| Fax |
|
| Email |
drkavitajain15@gmail.com |
|
|
Source of Monetary or Material Support
|
| JLN MEDICAL COLLEGE, AJMER |
|
|
Primary Sponsor
|
| Name |
JLN MEDICAL COLLEGE AJMER |
| Address |
Department of anaesthesiology, jln medical college, ajmer, rajasthan |
| 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 Vikas Gupta |
JLN MEDICAL COLLEGE, AJMER |
Department of anaesthesiology, jln medical college, ajmer
Ajmer
RAJASTHAN |
9694941940
vickybtp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, JLN medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.5% isobaric Ropivacaine alone and in combination with Dexmedetomidine for ultrasound guided Supraclavicular brachial plexus block. |
Compare the quality of anaesthesia and duration of block |
| Intervention |
Ultrasound guided SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK. |
Time of onset of block is assessed and duration of study is around 1 year. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age group between 15 and 65 years.
Body weight 30 to 80 kg.
Patients belonging to ASA (American Society of Anaesthesiologists) class-I and II.
Patients undergoing upper limb surgeries of duration 1-2 hours in theatre with haemoglobin at least 9 gm/dl.
Patient free from any associated acute or chronic systemic illness. |
|
| ExclusionCriteria |
| Details |
Patients not willing to participate in the study.
Uncooperative patients.
Patient with chronic pain or on long-term analgesics.
Any known hypersensitivity or contraindication to ropivacaine, dexmedetomidine.
Local pathology at the site of injection or disability limiting the performance of block.
Patients receiving beta blockers or cardiac drugs.
History of convulsion, allergy to the drug used, bleeding disorder, severe neurological deficit, thyroid disorder.
Patient with history of respiratory, cardiac, hepatic or renal disease (necessitating classification in ASA Class III or above).
Patients having a history of significant neurological, psychiatric, or neuromuscular disorders.
Pregnant, lactating mothers.
Inadequate block necessitating institution of general anaesthesia for continuation of surgical procedure. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess and compare the onset, duration and highest grade of sensory block.
To assess and compare the onset, duration and highest grade of motor block.
To assess and compare the total duration of effective analgesia by visual analog scale (VAS).
To assess and compare the peri-operative sedation Score. |
Duration of study is around 1 year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess and compare the quality of anaesthesia.
2. To assess and compare the hemodynamic changes if any.
3. To assess and compare the proportion of patient having adverse
effects and any other complications. |
Duration of study is around 1 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/01/2019 |
| Date of Study Completion (India) |
15/06/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of the study is to compare anaesthetic properties of 0.5% isobaric Ropivacaine alone and in combination with Dexmedetomidine in ultrasound guided Supraclavicular Brachial Plexus Block in upper limb surgeries in the terms of:-
PRIMARY OBJECTIVES: To assess and compare the onset, duration and highest grade of sensory block. To assess and compare the onset, duration and highest grade of motor block. To assess and compare the total duration of effective analgesia by visual analog scale (VAS). To assess and compare the peri-operative sedation Score.
SECONDARY OBJECTIVES: 1. To assess and compare the quality of anaesthesia. 2. To assess and compare the hemodynamic changes if any. 3. To assess and compare the proportion of patient having adverse effects and any other complications. |