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CTRI Number  CTRI/2018/02/011669 [Registered on: 02/02/2018] Trial Registered Retrospectively
Last Modified On: 29/01/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   “Comparison of low dose additives to local anaesthetic in ultrasound guided upper limb block.”  
Scientific Title of Study   “Comparison of low dose Dexmedetomidine and Clonidine as adjuvants to Bupivacaine 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 spurthi 
Designation  post graduate 
Affiliation  st.johns medical college 
Address  396,dharani,9th cross.3rd block,HMT Layout,near kalika durga parameshwari temple arch,vidyaranyapura.
st.johns medical college,sarjapura road,kormangala,bangalore-560034
Bangalore
KARNATAKA
560097
India 
Phone  8861402537  
Fax    
Email  spurthialse@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bindu George 
Designation  Guide 
Affiliation  St.johns medical college 
Address  St.johns medical college,sarjapura road,Kormangala,Bangalore
st.johns medical college,sarjapura road,kormangala,bangalore-560034
Bangalore
KARNATAKA
560034
India 
Phone  9342552324  
Fax    
Email  bindu575@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr spurthi 
Designation  post graduate 
Affiliation  st.johns medical college 
Address  396,dharani,9th cross.3rd block,HMT Layout,near kalika durga parameshwari temple arch,vidyaranyapura.
st.johns medical college,sarjapura road,kormangala,bangalore-560034
Bangalore
KARNATAKA
560097
India 
Phone  8861402537  
Fax    
Email  spurthialse@gmail.com  
 
Source of Monetary or Material Support  
Dr. spurthi, St. Johns medical college,sarjapura road,Kormangala,Bangalore- 560034 
 
Primary Sponsor  
Name  Dr spurthi 
Address  396,dharani,9th cross,3rd block,near durga parameshwari temple arch,HMT Layout,vidyaranyapura,bangalore-560097 
Type of Sponsor  Other [primary investigator] 
 
Details of Secondary Sponsor  
Name  Address 
Dr bindu george   st.johns medical college,sarjapura road,bangalore 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Spurthi  St johns medical college  Anaesthesia department,sarjapura road,Kormangala,Bangalore-560034
Bangalore
KARNATAKA 
8861402537
8861402537
spurthialse@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
St Johns Medical College Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ASA 1 & 2,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  COMPARISON OF LOW DOSE DEXMEDETOMIDINE AND CLONIDINE AS ADJUVANTS TO BUPIVACAINE IN ULTRASOUND GUIDED SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK  1 dose 0.5 microgram/kg of dexmedetomidine and clonidine added to 0.375% bupivacaine 2 nerve infiltration 3 duration of sensory block (till appearance of pain requiring analgesia) and duration of motor block (till complete return of the muscle power) was recorded. 4 frequency- single injection at the beginning of the study 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1 Adults aged 18 to 55 years undergoing elective and emergency upper limb surgical procedures under supraclavicular brachial plexus block
2 Weight range 40 to 80 kg
3 Adults belonging to either sex of ASA physical status Grade I and II

 
 
ExclusionCriteria 
Details  1 Patient refusal
2 Patients with pre existing neurological disorders like peripheral neuropathy or motor weakness
3 Known history of hypersensitivity to drugs used
4 History of significant cardiac respiratory renal hepatic or central nervous system diseases
5 Inadequate block
6 Infection at the site of the block
7 History of coagulopathy or anticoagulant medication intake
8 Pregnant or lactating women
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
1 To compare the onset of sensory and motor blockade
2 To compare the duration of sensory and motor blockade 
24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary objective
3 To evaluate the adverse effects of low dose adjuvants if any
4 To compare sedation scores 
24 hours 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2015 
Date of Study Completion (India) 01/01/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

ABSTRACT

Background:

Postoperative analgesia is a sine qua non in current clinical practice. However, perineural catheters for extending analgesia offered by local anaesthetics for peripheral nerve blocks are not yet very popular. So we are in need for an adjuvant that can prolong the action of local anaesthetics after single- injection blocks. Dexmedetomidine and clonidine are two commonly used adjuvants. This study was undertaken to assess which among them proved to be a superior analgesic adjuvant in lower doses.

Materials and Methods:

After ethical committee approval and written informed consent this study was conducted on 60 patients , aged 18-55 years, posted for upper limb surgery under USG guided supraclavicular brachial plexus block at St.John‘s Hospital, Bangalore. The study was conducted from January 2015-January 2016- Prospective Randomised double blind study. Preoperative baseline values of heart rate, blood pressure and oxygen saturation was recorded. Brachial plexus block by supraclavicular approach was carried out under USG guidance using strict aseptic precautions. Patients were assigned randomly to one of the two groups using computer generated tables:-

Group C- Clonidine 0.5 μg /kg added to 25ml of 0.375% bupivacaine.

Group D - Dexmedetomidine 0.5 μg /kg and 25ml of 0.375% bupivacaine.

The onset of sensory block, onset of motor block, the duration of analgesia, duration of  

motor block and sedation scores were assessed. Complications were also noted.

Results:

In our study the mean onset of sensory and motor block were faster in clonidine group than dexmedetomidine group. The mean onset of sensory block was 11.6 +/-3.4 minutes in group C, 14.4 +/-4.5 minutes in group D. The mean onset of motor block was 17.6 +/-4.9 in group C, 20.6+/-5.9 in group D. The duration of sensory block in Group C was 9.7+/-1.6 hours, 13.3+/-1.9 hours in Group D. Duration of motor blockade (hrs) was 9.1+/-1.7 in Group C, 12.1+/-2.0 in Group D. Duration of sensory and motor blockade was longer in Dexmedetomidine group than Clonidine group. First rescue was required at 10.5 ± 1.7 hrs in Clonidine group and at 15 ± 2.2 hrs in Dexmedetomidine group. None of the subjects in Clonidine group had side effects, wereas 10% of subjects in Dexmedetomidine group had side effects (Most common side effect observed was Bradycardia).

Conclusions:

Dexmedetomidine proves to be better adjuvant compared to clonidine as it notably prolongs analgesia and is also lesser complications at lower doses. But the prolonged motor block is still a matter of concern and the search for an adjuvant that selectively prolongs analgesia without impairing motor function continues.

Keywords:

Bupivacaine, Dexmedetomidine, Clonidine, Ultrasound, Supraclavicular brachial plexus block.

 

 

 
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