CTRI Number |
CTRI/2021/09/036351 [Registered on: 08/09/2021] Trial Registered Prospectively |
Last Modified On: |
07/09/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Medical Device Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
TO COMPARE THE EFFECTS OF ULTRASOUND-GUIDED BLOCK AT SHOULDER LEVEL WITH AND WITHOUT DEXAMETHASONE TO 0.5% LEVOBUPIVACAINE. |
Scientific Title of Study
|
TO COMPARE THE EFFECTS OF ULTRASOUND-GUIDED SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK WITH AND WITHOUT DEXAMETHASONE AS AN ADJUVANT TO 0.5% LEVOBUPIVACAINE. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Anshil Bhatia |
Designation |
Pg 1st year Anaesthesia |
Affiliation |
School of medical sciences & Research |
Address |
Department of Anaesthesiology School of Medical Sciences & Research Sharda University plot no 32,34, Knowledge park 3, Greater Noida
Gautam Buddha Nagar UTTAR PRADESH 201310 India |
Phone |
9896618924 |
Fax |
|
Email |
anshil.bhatia@sharda.ac.in |
|
Details of Contact Person Scientific Query
|
Name |
Dr Aarti Srivastava |
Designation |
Professor & Head of Department |
Affiliation |
School of medical sciences & Researc |
Address |
Department of Anaesthesiology School of Medical Sciences & Research Sharda University plot no 32,34, Knowledge park 3, Greater Noida
Gautam Buddha Nagar UTTAR PRADESH 201310 India |
Phone |
9811966766 |
Fax |
|
Email |
aarti.srivastava@sharda.ac.in |
|
Details of Contact Person Public Query
|
Name |
Dr Aarti Srivastava |
Designation |
Professor & Head of Department |
Affiliation |
School of medical sciences & Researc |
Address |
Department of Anaesthesiology School of Medical Sciences & Research Sharda University plot no 32,34, Knowledge park 3, Greater Noida
Balrampur UTTAR PRADESH 201310 India |
Phone |
9811966766 |
Fax |
|
Email |
aarti.srivastava@sharda.ac.in |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Sharda Hospital |
Address |
Department of Anaesthesiology School of Medical Sciences & Research Sharda University plot no 32,34, Knowledge park 3, Greater Noida |
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 |
Dr Anshil Bhatia |
Shara Hospital |
Department of Anaesthesiology School of Medical Sciences & Research Sharda University plot no 32,34, Knowledge park 3, Greater Noida Gautam Buddha Nagar UTTAR PRADESH |
09896618924
anshil.bhatia@sharda.ac.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
LEVOBUPIVACAINE |
Ultrasound- guided Supraclavicular Brachial plexus block
(1)Onset of sensory and motor blockade
(2)To record the total duration of sensory and motor blockade.(3)To observe the number of rescue analgesia given for post-operative pain relief. |
Intervention |
LEVOBUPIVACAINE WITH AN ADJUVANT DEXAMETHASONE |
Ultrasound- guided Supraclavicular Brachial plexus block
(1)Onset of sensory and motor blockade
(2)To record the total duration of sensory and motor blockade.(3)To observe the number of rescue analgesia given for post-operative pain relief.
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
ASA grade 1& 2.
Patients scheduled for ortho upper limb surgeries.
|
|
ExclusionCriteria |
Details |
1. Coagulopathy or anti-coagulation treatment.
2. History of allergy to local anesthetic.
3. Infection at the site of injection.
4. Significant neurological and psychiatric.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To record onset and total duration of sensory and motor blockade.
|
To record onset(for 20 mins) and total duration (for 24 hrs)of sensory and motor blockade. |
|
Secondary Outcome
|
Outcome |
TimePoints |
To record the total duration of sensory and motor blockade and to observe the number of rescue analgesia given for post-operative pain relief. |
24 hrs |
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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)
|
20/09/2021 |
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
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
The brachial plexus block is commonly performed procedure in anaesthetic practice today. It is used for analgesia as well as anaesthesia in upper limb procedures. This achieves near ideal operative conditions by producing complete muscular relaxation maintaining stable intraoperative haemodynamics and reduces post-operative pain, vasospasm and edema. Bupivacaine 0.5% is one of the most commonly used local anaesthetic agents because of its higher potency and prolonged duration of action. One of the drawbacks of bupivacaine is its cardiotoxicity which is near fatal, especially when injected accidentally into the artery. Levobupivacaine(S-enantiomer of Bupivacaine) local anaesthetic agent as it has a longer duration of action. However it has limiting factors like delayed onset, patchy and incomplete analgesia. Dexamethasone has been studied as an adjuvant to local anaesthetic in peripheral nerve block. Steroids have nerve block prolonging effects by blocking transmission of nociceptive myelinated c-fibres and suppressing ectopic neuronal discharge. They are also thought to alter the function of potassium channels in the excitable cells. Thus, dexamethasone is selected as an adjuvant to local anaesthetic (levobupivacaine) in a study because it has been reported to prolong duration of action of local anaesthetics with no respiratory depression. This in turn will help in titrating the dose of Bupivacaine there by optimizing this technique of analgesia. Dexamethasone is added to levobupivacaine to improve quality and duration of action thus providing for postoperative analgesia. Some studies suggest that when used as an adjuvant to peripheral nerve block in upper limb surgery, dexamethasone may prolong duration of sensory block and are effective in reducing postoperative pain intensity and opioid consumption. |