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CTRI Number  CTRI/2018/08/015389 [Registered on: 20/08/2018] Trial Registered Prospectively
Last Modified On: 16/08/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparison of Dexmedetomidine by two different routes with bupivacaine in ultrasound guided block for upper limb surgeries. 
Scientific Title of Study   A comparative study of dexmedetomidine by two different routes as an adjunct to bupivacaine in usg guided supraclavicular block for upper limb surgeries- A prospective randomized placebo controlled triple blind study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nishchint Sharma 
Designation  Junior resident  
Affiliation  Dr. RPGMC kangra at Tanda 
Address  Department of Anesthesia, Dr. Rajendra Prasad Govt. Medical College, Kangra at Tanda (H.P.)

Kangra
HIMACHAL PRADESH
176001
India 
Phone  8894111107  
Fax    
Email  nishchintsharma321@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shyam Bhandari 
Designation  Assistant Professor  
Affiliation  Rajendra Prasad Govt. Medical College, Kangra at Tanda (H.P.) 
Address  Department of Anesthesia , Dr Rajendra Prasad Govt. Medical College, Kangra at Tanda (H.P.)

Kangra
HIMACHAL PRADESH
176001
India 
Phone  9805098588  
Fax    
Email  dr.bhandari@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Shyam Bhandari 
Designation  Assistant Professor  
Affiliation  Rajendra Prasad Govt. Medical College, Kangra at Tanda (H.P.) 
Address  Department of Anesthesia , Dr Rajendra Prasad Govt. Medical College, Kangra at Tanda (H.P.)

Chamba
HIMACHAL PRADESH
176001
India 
Phone  9805098588  
Fax    
Email  dr.bhandari@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Anesthesia, Dr RPGMC, Kangra at Tanda- 176001 (H.P.) 
 
Primary Sponsor  
Name  Dr RPGMC Kangra at Tanda 
Address  Department of Anesthesia, Dr. Rajendra Prasad Govt. Medical College, Kangra at Tanda (H.P.) 
Type of Sponsor  Government 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 Nishchint Sharma  Dr Rajendra Prasad Govt. Medical College  OT-1 & 2,Department of Anesthesia
Kangra
HIMACHAL PRADESH 
8894111107

nishchintsharma321@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr RPGMC, Kangra at Tanda Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients undergoing Elective Surgeries in Supraclavicular Block ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Brachial Block  Ultasound Guided Supraclavicular Block 
Comparator Agent  Bupivacaine   20 ml of 0.5% Bupivacaine + 1ml Normal Saline and 1ml Normal Saline intramuscular  
Comparator Agent  Dexmedetomidine  20ml of 0.5% Bupivacaine + 50µg Dexmedetomidine in 1ml Normal Saline and 1ml Normal Saline intramuscular. 
Comparator Agent  Dexmedetomidine IM  20ml of 0.5% Bupivacaine + 1ml Normal saline and 1µg/kg Dexmedetomidine intramuscular 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. ASA class I-II
2. BMI 18.5-29.9
3. Undergoing surgeries around midarm, elbow, forearm and hand 
 
ExclusionCriteria 
Details  1. Patient’s refusal for block
2. History of cardiac, renal or hepatic disease, CNS disorders,neuropathy
3. Patients having bleeding disorders
4. Hypersensitivity to local anesthetics
5. Local infection at the site where needle for block is to be inserted
6. Patients noted to have dysrhythmias on the electrocardiogram (ECG)
7. Allergic to study drugs
8. Patients in whom the block effect will be partial and will require supplementary anesthesia
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To study and compare the onset and duration of sensory and motor blockade with two different routes of dexmedetomidine viz. perineural and intramuscular as an adjuvant to 0.5% bupivacaine in ultrasound guided supraclavicular brachial plexus block in patients scheduled for upper limb orthopaedic surgeries  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To study and compare sedation with different routes of dexmedetomidine  24 HOURS 
• To study and compare the hemodynamic stability of two different routes of dexmedetomidine.  24 HOURS 
To observe for side effects of dexmedetomidine in two different routes, if any.  24 HOURS 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   01/09/2018 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The purpose of this study is to compare the onset and duration of sensory and motor blockade with two different routes of dexmedetomidine viz. perineural and intramuscular as an adjuvant to 0.5% bupivacaine in ultrasound guided supraclavicular brachial plexus block. The study will be conducted for a period of 12 months. It will be a prospective, triple blind placebo control trial study. The patients will be allocated one of the three groups by block randomization. The study drug solution will be prepared by anesthesiologist not involved in the study. The anesthesiologist performing the block and anesthesiologist observing the patient, both will be blinded to the study groups. Data will be analyzed by the anesthesiologist who will be unaware of the group allocation.

The enrolled patients after fulfilling all the inclusion and exclusion criteria will be divided into 3 groups.(i) Group B (n=30) Control Group –20 ml of 0.5% Bupivacaine +1ml Normal Saline and 1ml Normal Saline intramuscular.(ii) Group BD (n=30) Dexmedetomidine Group–20 ml of 0.5% Bupivacaine + 50µg Dexmedetomidine in 1ml Normal Saline and 1ml Normal Saline intramuscular.(iii)Group BDIM (n=30) Dexmedetomidine IM Group –20 ml of 0.5% Bupivacaine + 1ml Normal saline and 1µg/kg Dexmedetomidine intramuscular.(A total volume of 21ml will be given in brachial plexus block)

Sensory and motor blockade will be assessed in territories of three nerves (radial, ulnar and median)  for every 3 min after completion of injection till 30 minutes and then for every 30 minutes after the end of surgery till the first 12 h, thereafter hourly until the block will have completely worn off.Sensory block (three nerve territories) will be assessed by pin prick test using a 3-point scale: 0 = normal sensation, 1 = loss of sensation of pin prick (analgesia), and2 = loss of sensation of touch (anesthesia) on dorsum of hand around anatomical snuff box for radial nerve, on hypothenar eminence for ulnar nerve, on medial side of thenar eminence for median nerve.  Motor block will be determined by thumb abduction (radial nerve), thumb adduction (ulnar nerve), thumb opposition (median nerve). Further block assessment will be done at hourly intervals up to 24 hours by a blinded anesthesiologist.

The primary outcome measure in this study will be the time to first analgesic request.

The secondary outcome measures include the number of supplemental analgesic requirements, VAS pain, nausea, patient satisfaction and onset and duration of sensory block and motor block episode of hypotension and bradycardia.

 
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