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.â€
|
Scientific Title of Study
|
“Comparison of low dose Dexmedetomidine and Clonidine as adjuvants to Bupivacaine in ultrasound guided supraclavicular brachial plexus blockâ€
|
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
|
|
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. |