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CTRI Number  CTRI/2026/02/104595 [Registered on: 24/02/2026] Trial Registered Prospectively
Last Modified On: 23/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study Comparing Two Pain Relieving Add on Medicines with Local Anaesthetic for Numbing the Arm During Upper Limb Surgeries 
Scientific Title of Study   Comparative Clinical Study Of Dexmedetomidine And Clonidine As Adjuvants To Levobupivacaine In Supraclavicular Brachial Plexus Block In Upper Limb Surgeries. 
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 Ajeet Jyotipurkar 
Designation  Assistant Professor 
Affiliation  NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital Nagpur 
Address  Department of Anaesthesiology, NKP Salve Institute Of Medical Sciences and Research Centre and Lata Mangeshkar Hospital,Digdoh Hills, Hingana road, Nagpur 440017
Department of Anaesthesiology, NKP Salve Institute Of Medical Sciences and Research Centre and Lata Mangeshkar Hospital,Digdoh Hills, Hingana road, Nagpur 440017
Nagpur
MAHARASHTRA
440017
India 
Phone  9561306782  
Fax    
Email  ajeet.jyotipurkar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ajeet Jyotipurkar 
Designation  Assistant Professor 
Affiliation  NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital Nagpur 
Address  Department of Anaesthesiology, NKP Salve Institute Of Medical Sciences and Research Centre and Lata Mangeshkar Hospital,Digdoh Hills, Hingana road, Nagpur 440017
Department of Anaesthesiology, NKP Salve Institute Of Medical Sciences and Research Centre and Lata Mangeshkar Hospital,Digdoh Hills, Hingana road, Nagpur 440017
Nagpur
MAHARASHTRA
440017
India 
Phone  9561306782  
Fax    
Email  ajeet.jyotipurkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ajeet Jyotipurkar 
Designation  Assistant Professor 
Affiliation  NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital Nagpur 
Address  Department of Anaesthesiology, NKP Salve Institute Of Medical Sciences and Research Centre and Lata Mangeshkar Hospital,Digdoh Hills, Hingana road, Nagpur 440017
Department of Anaesthesiology, NKP Salve Institute Of Medical Sciences and Research Centre and Lata Mangeshkar Hospital,Digdoh Hills, Hingana road, Nagpur 440017
Nagpur
MAHARASHTRA
440017
India 
Phone  9561306782  
Fax    
Email  ajeet.jyotipurkar@gmail.com  
 
Source of Monetary or Material Support  
NKP Salve Institute of Medical Sciences & Research centre and Lata Mangeshkar Hospital Nagpur 
 
Primary Sponsor  
Name  NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital 
Address  Department Of Anaesthesiology, NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road,Nagpur 
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 Ajeet Jyotipurkar  Lata Mangeshkar Hospital, Nagpur  Department of Anaesthesiology, Fourth Floor, Operation theatre complex, NKP Salve Institute of Medical Sciences, Digdoh Hills, Hingna Road, Nagpur
Nagpur
MAHARASHTRA 
9561306782

ajeet.jyotipurkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital  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  Levobupivacaine with Dexmedetomidine And Levobupivacaine with Clonidine.  19ml of 0.5% Levobupivacaine and 0.75 mcg/kg of Dexmedetomidine diluted to 1ml with Normal Saline for a total volume of 20ml And 19ml of 0.5% Levobupivacaine and 1 mcg/kg of Clonidine diluted to 1ml with Normal Saline for a total volume of 20ml 
Intervention  Supraclavicular block  Supraclavicular brachial plexus block will be performed for providing anaesthesia and analgesia for upper limb surgeries. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  American Society of Anaesthesiologists physical status 1 and 2
Body Mass Index less than 30 kg per m2.
 
 
ExclusionCriteria 
Details  History of allergy to study drug.
Infection at the site of injection.
Coagulopathies.
Patients on Beta blockers.
Neurological deficit in the operating arm.
Patients on anti psychotic and anti epileptic drugs.
Patient not willing to participate. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate efficacy of Dexmedetomidine as an adjuvant to 0.5% Levobupivacaine versus Clonidine with 0.5% Levobupivacaine in Ultrasound-Guided Supraclavicular Brachial Plexus Block for Upper Limb Surgeries in terms of
1.Onset of sensory blockade .
2.Onset of motor blockade.
3.Duration of sensory blockade
4.Duration of motor blockade.
5.Intensity of motor blockade. 
Time of completion of injection of local anaesthetic will be labelled as 0 minutes
After the block performance assessment of onset and duration of sensory block will be done by loss of sensation of pin prick
onset and duration of motor block assessment will be done by bromage scale.
Assessment of sensory and motor blockage will be done every 5 mins post block performance till 30 mins and then at an interval of 1 hr post surgery till the first 12 hrs and until the block had worn off completely.
Assessment of intensity of motor blockade will be assessed every 5 mins till grade 3 motor block is achieved. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate postoperative analgesia with Dexmedetomidine as an adjuvant to 0.5% Levobupivacaine versus Clonidine with 0.5% Levobupivacaine in Ultrasound-Guided Supraclavicular Brachial Plexus Block for Upper Limb Surgeries in terms of
1.Visual analogue score for pain assessment.
2.Time for requirement of first rescue analgesia.
3.Total analgesic requirement in 24 hours.
4.Complications like Hypotension , Bradycardia , Sedation. 
Time of completion of injection of local anaesthetic will be labelled as 0 minutes.
Visual Analog Score will be assessed immediately post operatively
Total rescue analgesia will be assessed in 24 hours
Hemodynamic parameters and sedation will be monitored every 5 mins for first 30 mins and then every 30 mins for the rest of the surgery. 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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 3 
Date of First Enrollment (India)   15/03/2026 
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 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  

Regional blocks have secured a pivotal role in modern anaesthetic practice with their ability to achieve ideal operative conditions without much of systemic side effects. They offer an excellent alternative for patients who are hemodynamically compromised or too ill to tolerate general anaesthesia . For the majority of upper limb surgeries carried out on a daily basis, supraclavicular brachial plexus blockade is the technique of choice due to its effectiveness in terms of success rates, margin of safety, and efficient postoperative analgesia .

                  The first supraclavicular brachial plexus block was performed by Kulenkampff D in 1912 .Though relatively new, ultrasonographic visualization of the targeted nerves shows promise for the future. This makes it possible to see the block needle, the distribution of local anesthetic, and peripheral nerves directly. Past few years have observed a great increase in the use of ultrasound for regional nerve blocks.

                 An ideal drug should have a fast sensory onset, differential offset, with an earlier offset of motor than sensory blockade, enabling early ambulation or movements with prolonged analgesia. Several combinations of LAs and adjuvants such as tramadol,  sufentanil,  clonidine and fentanyl have been employed in the search for near ideal agent, which has proven to be unattainable

               Currently, levobupivacaine ie S enantiomer of bupivacaine with favorable clinical profile and lesser cardiotoxicity when compared with racemic bupivacaine is being favoured LA for regional block.

              Dexmedetomidine, a pharmacologically active dextro-isomer of medetomidine, is a selective alpha adrenoceptor agonist employed for use as an adjuvant during regional anaesthesia.It inhibits the neuronal conduction by blocking hyperpolarization activated cation currents and produces analgesia.           

               Dexmedetomidine has been added perineurally at various doses; however, the optimal dose is still unknown. Analgesia lasts longer at higher doses of dexmedetomidine, such as 1to 2 mcg per kg, but at the expense of more adverse effects, such as bradycardia and hypotension.There are very few studies which evaluated the efficacy of low dose ie 30mcg of dexmedetomidine as an adjuvant to local anaesthetic to prolong the block characteristics.

             Clonidine had been used as an adjunct to local anaesthetic agents in various regional techniques to extend the duration of block. It is a centrally acting alpha-2 adrenergic agonist. It has been added perineurally at various doses; however, the optimal dose is still unknown. Analgesia lasts longer at higher doses of clonidine.

               Hence this study aims to evaluate the efficacy of 0.5 mcg per kg dexmedetomidine with 0.5 percent levobupivacaine versus 1 mcg per kg clonidine with 0.5 percent levobupivacaine in ultrasound guided supraclavicular block which can be beneficial to Indian population. 
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