CTRI Number |
CTRI/2025/03/082493 [Registered on: 17/03/2025] Trial Registered Prospectively |
Last Modified On: |
17/03/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparing two doses of dexamethasone in addition to Levobupivacaine in Supraclavicular Brachial Plexus Block for Upper limb Orthopaedic Surgeries |
Scientific Title of Study
|
Comparing Variable Doses Of Dexamethasone As An Adjuvant To Levobupivacaine In Ultrasound Guided Supraclavicular Brachial Plexus Block For Patients Undergoing Orthopaedic Upper Limb Surgeries – A Prospective Study |
Trial Acronym |
Nil |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DR Ashwin Suuraj V |
Designation |
Senior Resident |
Affiliation |
Ortho-One Orthopaedic Speciality Centre |
Address |
Department of Anaesthesiology
OT Complex 3rd Floor
Ortho-One Orthopaedic Speciality Centre
657 & 658 Trichy road , Singanallur , Coimbatore
Coimbatore TAMIL NADU 641005 India |
Phone |
8754026064 |
Fax |
|
Email |
ashwinsuuraj55@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DR Ashwin Suuraj V |
Designation |
Senior Resident |
Affiliation |
Ortho-One Orthopaedic Speciality Centre |
Address |
Department of Anaesthesiology
OT Complex, 3rd Floor , Ortho-One Orthopaedic Speciality Centre ,
657 & 658 , Trichy Road , Singanallur , Coimbatore
Coimbatore TAMIL NADU 641005 India |
Phone |
8754026064 |
Fax |
|
Email |
ashwinsuuraj55@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DR Ashwin Suuraj V |
Designation |
Senior Resident |
Affiliation |
Ortho-One Orthopaedic Speciality Centre |
Address |
Department of Anaesthesiology
OT Complex, 3rd Floor , Ortho-One Orthopaedic Speciality Centre
657 & 658 ,Trichy Road , Singanallur , Coimbatore
Coimbatore TAMIL NADU 641005 India |
Phone |
8754026064 |
Fax |
|
Email |
ashwinsuuraj55@gmail.com |
|
Source of Monetary or Material Support
|
Ortho-One Orthopaedic Speciality Centre
657 & 658 , Trichy Road , Singanallur , Coimbatore , Tamil Nadu , India - 641005 |
|
Primary Sponsor
|
Name |
OrthoOne Orthopaedic Speciality Centre |
Address |
Ortho-One Orthopaedic Speciality Centre
657 & 658 Trichy Road Singanallur Coimbatore 641005 |
Type of Sponsor |
Private hospital/clinic |
|
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 |
Ashwin Suuraj |
Ortho-One Orthopaedic Speciality Centre |
Ortho-One Orthopaedic Speciality Centre
657 & 658 Trichy Road Singanallur Coimbatore - 641005 Coimbatore TAMIL NADU |
8754026064
ashwinsuuraj55@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL HUMAN ETHICS COMMITTEE ORTHO-ONE ORTHOPAEDIC SPECIALITY CENTRE |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: S629||Unspecified fracture of wrist andhand, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Inj. Dexamethasone |
Inj. Levobupivacaine 0.25 % 20 ml + Inj . Dexamethasone 4 mg
diluted to 2 ml with NS = 22 ml. |
Comparator Agent |
Inj. Dexamethasone |
Inj. Levobupivacaine 0.25 % 20 ml + Inj . Dexamethasone 6 mg
diluted to 2 ml with NS = 22 ml. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
Elective and Emergency Orthopaedic Upper limb surgeries
ASA I , II and III |
|
ExclusionCriteria |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Centralized |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To assess the duration of analgesia between 4 mg of dexamethasone and 6 mg of dexamethasone
added to levobupivacaine |
0 hours , 2 hours , 4 hours , 8 hours , 12 hours , 24 hours |
|
Secondary Outcome
|
Outcome |
TimePoints |
To assess the time taken for onset of sensory & motor block |
0 mins , 2 mins , 4 mins , 6 mins , 8 mins , 10 mins , 12 mins , 14 mins , 15 mins |
To assess the total requirement of rescue analgesia over a period of 24 hours post-
operatively |
0 hours - 24 hours |
To assess the Intensity of pain , Haemodynamic status of patients over 24 hours |
0 hours to 24 hours |
|
Target Sample Size
|
Total Sample Size="58" Sample Size from India="58"
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)
|
02/04/2025 |
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="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Supraclavicular Brachial Plexus block is a good alternative to general anaesthesia for upper
limb orthopaedic surgeries. This avoids the untoward effects of general anaesthetic drugs and
upper airway instrumentation in patients.
It achieves muscle relaxation, intraoperative hemodynamic stability and post-operative analgesia and reduces the requirement of post-operative opioid usage.
Considering the pharmacological profile of Bupivacaine, its clinical efficacy, long duration of action and favourable ratio of sensory to motor block it is used most frequently among local anaesthetics for brachial plexus block. However its major disadvantage is cardiotoxicity, primarily triggered by its dextrogyrous enantiomer Levobupivacaine, a pure S- enantiomer of Bupivacaine has potentially reduced toxic profile compared to Bupivacaine. Levobupivacaine is a better drug for regional block due to its low cardiotoxic profile compared to Bupivacaine. Levobupivacaine’s efficacy proved similar or greater than Bupivacaine in regional blocks and could be used more safely in ASA grade 3 and 4 patients and cardiac patients in whom general anaesthesia is risky. Peripheral nerve blocks with local anaesthetics provide excellent operating conditions, facilitate early mobilisation and bypass the post anaesthesia care unit, but duration of analgesia is rarely maintained for more than 4-8 hours even with the longest acting local anaesthetics. Perineural catheters can improve duration of analgesia from local anaesthetics but carry problems of catheter migration, pump malfunction, leakage, etc. Therefore, many adjuvants are added to the local anaesthetic in single shot regional
technique with variable results. Different drugs have been used as adjuvants with local
anaesthetics in brachial plexus block to achieve a quick, dense and prolonged block.
Various studies have shown that addition of corticosteroid dexamethasone, as a non
particulate injection, to local anaesthetics prolongs duration of blockade by approximately
8-10 hours in peripheral nerves.
However, the administration of dexamethasone is not risk free and concerns have been raised
regarding hyperglycaemia and surgical site infection. These adverse effects are likely to be
dose dependent. Owing to the potential toxicity concern, it may be beneficial to use lower
doses of dexamethasone, if these provide similar increase in analgesia duration compared to
higher doses The purpose of this study is to compare the effectiveness, duration and quality of motor blockade and sensory blockade between patients receiving of two relatively low doses (4 mg and 6 mg) of dexamethasone, used as adjuvant to 0.25% levobupivacaine, for supraclavicular
brachial plexus block in patients undergoing upper limb orthopaedic surgeries
|