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CTRI Number  CTRI/2024/07/069905 [Registered on: 04/07/2024] Trial Registered Prospectively
Last Modified On: 03/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Dexmedetomidine and Fentanyl are compared being an adjuvant to Levobupivacaine in case of upper limb surgeries 
Scientific Title of Study   Comparison of dexmedetomidine & fentanyl as an adjuvant to levobupivacaine in peripheral nerve stimulator guided supraclavicular brachial plexus block 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mamta Agrawal 
Designation  Post Graduate Student 
Affiliation  Peoples College of Medical Sciences 
Address  Room no 1 Department of Anaesthesia 1st floor Peoples Hospital Karond Bypass Road Bhanpur Bhopal Madhya Pradesh

Bhopal
MADHYA PRADESH
462037
India 
Phone  9870302512  
Fax    
Email  dr.mamta201023@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mahima Batra 
Designation  Professor and Head 
Affiliation  Peoples College of Medical Sciences 
Address  Room no 2 Department of Anaesthesia 1st Floor Peoples Hospital Karond Bypass Road Bhanpur Bhopal Madhya Pradesh

Bhopal
MADHYA PRADESH
462037
India 
Phone  9752075418  
Fax    
Email  drmahimabatra@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mahima Batra 
Designation  Professor and Head 
Affiliation  Peoples College of Medical Sciences 
Address  Room no 2 Department of Anaesthesia 1st Floor Peoples Hospital Karond Bypass Road Bhanpur Bhopal Madhya Pradesh

Bhopal
MADHYA PRADESH
462037
India 
Phone  9752075418  
Fax    
Email  drmahimabatra@gmail.com  
 
Source of Monetary or Material Support  
Peoples Hospital Peoples College of Medical Sciences and Research Centre Peoples University Karond Bypass Road Bhanpur Bhopal Madhya Pradesh 462037 
 
Primary Sponsor  
Name  Peoples College of Medical Sciences And Research Centre 
Address  Peoples Hospital Peoples College of Medical Sciences and Research Centre Karond Bypass Road Bhanpur Bhopal Madhya Pradesh 462037 
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 MAMTA AGRAWAL  Peoples Hospital  Room no 1 First Floor Department of Anaesthesia Peoples Hospital Karond Bypass Road Bhanpur Bhopal Madhya Pradesh 462037
Bhopal
MADHYA PRADESH 
9870302512

dr.mamta201023@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE PCMS RC BHOPAL  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 
Comparator Agent  Dexmedetomidine   Dexmedetomidine as an adjuvant to levobupivacaine in case of elective upper limb surgeries under Supraclavicular Brachial Plexus Block 
Intervention  Fentanyl  Fentanyl as an adjuvant to levobupivacaine in case of elective upper limb surgeries under Supraclavicular Brachial Plexus Block 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA Grade 1 and 2
All patients scheduled for elective upper limb surgeries under Supraclavicular Brachial Plexus Block 
 
ExclusionCriteria 
Details  Patient not giving consent
Age less than 18 years and more than 60years
ASA grade 3 and more
Patients with abnormal coagulation profile
Patient with history of opioid abuse
Patients with local skin site infections
Patients with hypersensitivity to any of the drugs used
Pregnant and lactating mothers
Failure of Block 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of sensory and motor blockade in the form of response to pin prick test and modified bromage scale  300 minutes or the entire duration of surgery whichever is earlier 
 
Secondary Outcome  
Outcome  TimePoints 
Onset of sensory & motor blockade  For approximately 60 minutes after the administration of the drug  
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
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)   15/07/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Brachial plexus block is one of the approaches to sensorimotor neural blockade by which surgical
anaesthesia of the upper limb may be achieved. It is preferred in upper limb surgeries because it has certain
advantages over general anaesthesia. It is safer in patients who are at high risk for general anaesthesia,
provides good postoperative analgesia and is economical.

The supraclavicular approach to brachial plexus block provides anaesthesia of the upper extremity in the
most consistent and time efficient manner. It has a high success rate and rapid onset of action. Peripheral
nerve blocks have an increasingly important role in ambulatory anaesthesia.

Local anaesthetic agents are compounds that have the ability to interrupt the transmission of the action
potential of excitable membranes by binding to specific receptors in the Na+ channels. Adjuvants have
been added to increase duration of analgesia and reduce total dose of local anaesthetic agents used
minimizing the risk for local anaesthetic agent toxicity.

Levobupivacaine is the newer local anesthetic agent introduced in clinical practice. It is the pure S(-)-
enantiomer of the racemic formulation bupivacaine. Whereas both the R- and S-enantiomers of bupivacaine
have anesthetic activity, preclinical studies suggested that levobupivacaine might be less cardiotoxic than the
racemic mixture. It acts by reversibly blocking neuronal intracellular Na+ channels, preventing
depolarization.

Dexmedetomidine (α2 adrenoceptor agonist) is being used for intravenous (IV) sedation and
analgesia for intubated and mechanically ventilated patients in Intensive Care Units. Its use in
peripheral nerve blocks has recently been described. When used as an adjuvant to local anaesthetic
agent it has been reported to have a rapid onset time, prolong the duration, and is safe in peripheral
nerve blocks.

Opiates are widely known to have an analgesic effect at the central and spinal cord level. However,
opioid analgesia can be initiated by activation of peripheral opioid receptors. Opioids such as
fentanyl have been used for regional nerve plexus blocks to improve the block duration and
quality. The peripheral administration of opioids provides prolonged analgesia without systemic
side effect.[4] Studies have shown better block duration and success rate of brachial plexus block
on addition of fentanyl.

Need for the study:

A number of studies have evaluated the efficacy of both the drugs, either independently or in
combination with other local anaesthetic agents. There are limited studies comparing the use of
fentanyl with levobupivacaine to dexmedetomidine with levobupivacaine. Considering the low
side effect and excellent postoperative analgesic efficacy of two drugs, it is essential to carry out
a comparative evaluation of two drugs for their adjuvant use with levobupivacaine in
supraclavicular block among patients undergoing upper limb orthopedic surgeries.
 
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