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CTRI Number  CTRI/2017/03/008199 [Registered on: 23/03/2017] Trial Registered Retrospectively
Last Modified On: 10/03/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   supraclavicular brachial plexus block with Levobupivacaine and Dexmeditomidine 
Scientific Title of Study   Effect of Dexmedetomidine on characteristics of ultrasound guided supraclavicular brachial plexus block with Levobupivacaine- a prospective double blind randomized controlled trial.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhumireddy Suneel reddy  
Designation  Junior Resident 
Affiliation  Kasturba Medical College , Manipal 
Address  Department of Anaesthesiology, Kasturba Medical College,Manipal University, Manipal

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  suneelreddy547@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Yogesh K Gaude 
Designation  Assistant professor 
Affiliation  Kasturba Medical College , Manipal 
Address  Department of Anaesthesiology, Kasturba Medical College,Manipal University, Manipal

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  yogeshgaude@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr KGurudas Kini 
Designation  Professor 
Affiliation  Kasturba Medical College , Manipal 
Address  Department of Anaesthesiology, Kasturba Medical College,Manipal University, Manipal

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  kini.gurudas@gmail.com  
 
Source of Monetary or Material Support  
PG Thesis fund, Manipal University,Madhavnagar, Manipal, Karnataka , India 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
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 Bhumireddy Suneel reddy   Kasturba Hospital, Manipal  Department of Anaesthesiology, OT Complex Kasturba Medical College,Manipal University, Manipal
Udupi
KARNATAKA 
07760003883

suneelreddy547@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Hospital, Manipal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  American society of anesthesiologists (ASA) physical status: I-II,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Levobupivacaine in ultrasound guided supraclavicular brachial plexus block  Group L- Patients receiving (30ml 0.5% Levobupivacaine +1ml normal saline) perineural + 20 ml 0.9% Normal saline IV infusion over 20 minute to be started soon after performance of nerve block.  
Comparator Agent  Levobupivacaine with intravenous Dexmedetomidine in ultrasound guided supraclavicular brachial plexus block  Group LDi- Patients receiving (30ml of 0.5% Levobupivacaine + 1ml normal saline) perineural + dexmedetomidine 1ug/kg in 20ml 0.9% Normal saline IV infusion over 20 minute to be started soon after performance of nerve block. 
Comparator Agent  Levobupivacaine with perineural Dexmedetomidine in ultrasound guided supraclavicular brachial plexus block  Group LDp- Patients receiving (30ml of 0.5% Levobupivacaine + 1mcg/kg of Dexmedetomidine in 1ml normal saline) perineural+ 20ml 0.9% Normal saline IV infusion over 20 minute to be started soon after performance of nerve block. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age: 18 – 60 years
2. American society of anesthesiologists (ASA) physical status: I-II
3. Elbow, forearm and hand surgeries
 
 
ExclusionCriteria 
Details  1. Patient refusal for procedure
2. Any bleeding disorder or patients on anticoagulants
3. Neurological deficits involving brachial plexus
4. Body weight less than 50 Kg
5. Patients with known allergy to local anaesthetics
6. Local infection at injection site
7. History of seizures
8. History of pneumothorax
9. Pregnant women
10. ASA grade III-IV
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.The onset of sensory and motor block
2.Duration of sensory/ motor blockade
 
Time interval between administration of study drug to loss of pin prick sensation in all 4 nerve territories. Time interval between of administration of study drug to a motor score of 2 or lower according to modified Bromage scale in all 4 nerve territories.Time interval between loss of pin prick sensation to reappearance of sensation in all 4 nerve territories.
Time interval between attainment of ≤Grade 2 motor block to complete recovery of motor power in all 4 nerve territories.
 
 
Secondary Outcome  
Outcome  TimePoints 
Sedation score
Complications / side effects if any
 
sedation score will be assessed after completion of block and every 5 min till end of surgical procedure.
Immediate complications will be noted and side effects will be noted post operatively  
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/09/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Brachial plexus block at various levels has been in use for upper extremity surgeries since its description by Kulenkampff in 1928(1). Supraclavicular approach to brachial plexus block has remained the most popular because of its ubiquitous application for upper extremity surgeries, predictability and complete anesthesia of upper limb(2). After a brief period of disfavor due to risk of pneumothorax, application of nerve stimulation and recent introduction of ultrasonography for localization of brachial plexus has rekindled anesthesiologist’s interest in supraclavicular block(3).

Although bupivacaine remains commonly used local anesthetic for performance of nerve blocks due to its long duration of action and good motor blockade, concerns about toxicity at higher doses remain. Levobupivacaine, a less cardiotoxic s- isomer of bupivacaine is proved to be similar to bupivacaine if not for pharmaco-economic considerations hence proposed as a safer alternative to the former for performance of nerve blocks(4).

Even with increasing use of perineural catheters for pain relief, many anesthesiologists still continue to use single-shot techniques for nerve blocks. This has led to the practice of using additives to local anesthetics with intent to improve the quality and duration of block. Among others, selective α2 agonist dexmedetomidine has been studied for its ability to affect the axillary brachial plexus block characteristics. Intravenous administration of dexmedetomidine along with spinal anesthesia has been found to prolong the duration of block(5–7). Few studies have evaluated the effect of intravenous dexmedetomidine on brachial plexus block(8). Albeit the availability of studies on the effect of dexmedetomidine on axillary brachial plexus block performed by nerve stimulator guidance with Levobupivacaine (9), no study has evaluated the effect of dexmedetomidine on ultrasound guided supraclavicular brachial plexus block with Levobupivacaine. 

 
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