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CTRI Number  CTRI/2023/02/050078 [Registered on: 24/02/2023] Trial Registered Prospectively
Last Modified On: 23/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study comparing two different doses of Injection Dexmedetomidine when added to Injection Levobupivacaine (0.5% concentration) for ultrasound guided supraclavicular brachial plexus nerve block in elective upper limb surgeries. 
Scientific Title of Study   A Comparative study between two different doses of Dexmedetomidine as adjuvant to 0.5 % Levobupivacaine in ultrasound guided supraclavicular brachial plexus block.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Noel Tobin 
Designation  Junior Resident 
Affiliation  Mgm mediacal college 
Address  Room NO 570 OT Complex Mgm medical college aurangabad Maharashtra
MGM MEDICAL COLLEGE AND HOSPITAL N6 CIDCO AURANGABAD MAHARASHTRA
Aurangabad
MAHARASHTRA
431003
India 
Phone  9496982892  
Fax    
Email  noeltobinm@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pramod Vasantrao Bhale 
Designation  Professor 
Affiliation  Mgm Medical college  
Address  Department of Anaesthesia MGM Medical College and Hospital N6 CIDCO Aurangabad Department of Anaesthesia MGM Medical College and Hospital N6 CIDCO Aurangabad Aurangabad MAHARASHTRA

Aurangabad
MAHARASHTRA
431003
India 
Phone  8888819021  
Fax    
Email  pramod.bhale@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pramod Vasantrao Bhale 
Designation  Professor 
Affiliation  Mgm mediacal college 
Address  Department of Anaesthesia MGM Medical College and Hospital N6 CIDCO Aurangabad Department of Anaesthesia MGM Medical College and Hospital N6 CIDCO Aurangabad Aurangabad MAHARASHTRA

Aurangabad
MAHARASHTRA
431003
India 
Phone  8888819021  
Fax    
Email  pramod.bhale@gmail.com  
 
Source of Monetary or Material Support  
MGM MEDICAL COLLEGE AND HOSPITAL AURANGABAD 
 
Primary Sponsor  
Name  MGM Medical College and Hospital Aurangabad 
Address  Department of Anaesthesia MGM Medical College and Hospital N6 CIDCO Aurangabad 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Noel Tobin  MGM MEDICAL COLLEGE AND HOSPITAL  OT ROOM NO 6 OT COMPLEX MGM MEDICAL COLLEGE AND HOSPITAL N6 CIDCO AURANGABAD MAHARASHTRA
Aurangabad
MAHARASHTRA 
9496982892

noeltobinm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MGM Ethics Committee For Research on Human Subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Levobupivacaine Plus Dexmedetomidine  Supraclavicular brachial plexus block with 20 ml 0.5% Levobupivacaine plus 0.5 microgram per kilogram dexmedetomidine under ultrasound guidance. 
Intervention  Levobupivacaine Plus Dexmedetomidine  Supraclavicular brachial plexus block with 20 ml 0.5% Levobupivacaine plus 1 microgram per kilogram dexmedetomidine under ultrasound guidance. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients of ASA physical grade I –II
2.18-65 years of age
3.Both sexes
4.Posted for elective surgeries of midarm forearm and hand will be included. 
 
ExclusionCriteria 
Details  1.Patient refusal
2.History of infection at site of block
3.Coagulopathies
4.Patients with known hypersensitivity to local anaesthetic or dexmedetomidine
5.Presence of 1st, 2nd or 3rd degree heart block
6.Pregnant women
7.Patients on beta blockers
Pre-existing peripheral neuropathy
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1)Heart rate
2)Mean arterial pressure
3)Saturation
 
1.Time at which procedure of giving block is finished.
2)Five minute
3)Ten minute
3)Fifteen minute
4)Twenty minute
5)Fourty minute


 
 
Secondary Outcome  
Outcome  TimePoints 
1.Heart rate
2.Mean arterial pressure
3.Intraoperative sedation score
 
1)Sixty minute
2)Eighty minute
3)Hundred minute
4)One twenty minute
5)One fourty minute 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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   Phase 4 
Date of First Enrollment (India)   28/02/2023 
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="2"
Months="0"
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   Brachial plexus block has evolved into an excellent substitute to general anaesthesia for upper limb surgeries. It curtails the stress response and using minimal anaesthetic drugs  it provides  intraoperative analgesia with prolonged post operative pain relief. Among the various upper limb blockades, supraclavicular brachial plexus block (SCBP) is considered as ’spinal of arm’.
Brachial plexus block is a peripheral block commonly used for upper limb surgery. Ultrasound guided supraclavicular brachial plexus block facilitate more accurate and effective method of drug administration.
Levobupivacaine is used for this study as it has advantages of long acting and less cardiotoxic and neurotoxic. Levobupivacaine has  recently been used more for supraclavicular brachial plexus block due to the above mentioned advantages.
The idea behind using an adjuvant with local anaesthetic is to reduce the requirement of analgesics in post operative period.
Various adjuvants have been studied for prolonging the effect of supraclavicular blocks(4). Alpha 2 adrenoreceptor agonist such as clonidine and dexmedetomidine are the two most commonly used drugs. They have shown sedation, analgesia, sympatholysis,cardiac stabilization and anaesthetic sparing properties. Out of these dexmedetomidine an imidazole compoind is more selective than clonidine(eight times).Dexmedetomidine causes analgesia by its action at supraspinal (locus coeruleus) or at spinal level or even at peripheral Alpha 2 receptors by the reduction of transmission of nociceptive stimulus.(2).
This study compares the effects of two different doses of dexmedetomidine as an adjuvant added to 0.5% Levobupivacaine. In our study we are using ultrasound guided technique for supraclavicular brachial plexus block.
In this study we hypothesise that two different doses of dexmedetomidine (0.5 & 1 microgram per kg) are equallyt effective.   
 
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