Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001151628
Ethics application status
Approved
Date submitted
31/08/2014
Date registered
31/10/2014
Date last updated
10/02/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study for comparison of onset and duration of block in 3 groups of participants following ultrasound guided supraclavicular brachial plexus block using 0.5% Ropivacaine or 0.5% Ropivacaine with dexmedetomidine or 0.5% Ropivacaine with midazolam.
Scientific title
Comparative study of additive to ropivacaine to assess the block characteristics following brachial plexus block for patients undergoing elective upper limb orthopaedic surgery.
Secondary ID [1] 284913 0
Nil
Universal Trial Number (UTN)
U1111-1158-8168
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthesiology for elective upper limb orthopaedic surgery. 292915 0
Condition category
Condition code
Anaesthesiology 293202 293202 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 Groups of patients based on the study medication used.
Group R: Injection 30 ml 0.5% Ropivacaine + 1 ml 0.9% Saline
Group D: Injection 30 ml 0.5% Ropivacaine + 1mcg/kg of Dexmedetomidine in 1ml 0.9% saline
Group M: Injection 30 ml 0.5% Ropivacaine + 0.05mg/kg of Midazolam in 1ml 0.9% saline
All medications administered in periplexus region around brachial plexus under ultrasound guidance.
Intervention code [1] 290145 0
Treatment: Drugs
Comparator / control treatment
Group R: Patients receiving periplexus injection of 30 ml 0.5% Ropivacaine with 1 ml 0.9% saline.
Control group
Active

Outcomes
Primary outcome [1] 293071 0
Duration of motor blockade
Timepoint [1] 293071 0
Assessed using Modified Bromage criteria:
Grade 0: Normal motor function
Grade 1: Ability to move only fingers
Grade 2: Complete motor block with inabilty to move below wrist and finger
Assessed every half hourly for first 6 hours and every hourly for next 18 hours till complete recovery of motor block.
Primary outcome [2] 293212 0
Duration of sensory blockade
Timepoint [2] 293212 0
Assessed by checking dermatomal sensations using tooth pick prick. Grading: Grade 0: Sharp prick felt Grade 1: Analgesia, dull sensation felt Grade 2: Anaesthesia, no sensation felt Assessed every half hourly for first 6 hours and every hourly for next 18 hours till complete recovery of sensory block.
Primary outcome [3] 293213 0
Time to rescue analgesia
Timepoint [3] 293213 0
Time from injection of medication to the point when patient asks for first rescue analgesia.
Secondary outcome [1] 310290 0
Onset of motor blockade
Timepoint [1] 310290 0
Assessed using Modified Bromage criteria
Assessed every 3 minutes till onset of complete motor block
(Grade 2)
Secondary outcome [2] 310601 0
Onset of sensory blockade
Timepoint [2] 310601 0
Assessed using loss of dermatomal tooth pick prick sensation (grading same as primary outcome 2) Assessed every 3 minutes till onset of complete sensory block (Grade 2)
Secondary outcome [3] 310618 0
Sedation score
Timepoint [3] 310618 0
Assessed at 1 hour, 2 hours, 3 hours, 4 hours, 5 hours and 6 hours from time of injection.
Grade 1: Awake and alert
Grade 2: Sedated, responding to verbal stimulus
Grade 3: Sedated, responding to mild physical stimulus
Grade 4: Sedated, responding to moderate or severe physical stimulus
Grade 5: Not arousable

Eligibility
Key inclusion criteria
Patients aged between 18 to 60 years, weighing >50 kilograms, belonging to American Society of Anaesthesiologists physical status 1 or 2, posted for elective upper limb (elbow or forearm) orthopaedic surgery under supraclavicular brachial plexus block.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients refusing nerve block, having brachial plexus deficits, on anticoagulants or having bleeding disorders, with history of seizures or local anaesthetic allergy and belonging to American Society of Anaesthesiologists physical status 3 or 4.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomization table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size calculated using data from previous studies for the primary outcome of duration of sensory and motor blockade (Assuming a 30% difference between the groups clinically). The calculated sample size was 16 per group (For statistical power of 80%) and 19 per group (For statistical power of 90%). Hence 20 participants were enrolled in each group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2014
Actual
1/08/2014
Date of last participant enrolment
Anticipated
Actual
5/12/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 6330 0
India
State/province [1] 6330 0

Funding & Sponsors
Funding source category [1] 289886 0
University
Name [1] 289886 0
Kasturba medical college, Manipal University
Country [1] 289886 0
India
Primary sponsor type
Individual
Name
Sethulakshmi Prasad
Address
Room number: 220
Sonia hostel
Kasturba Medical College campus
Manipal .P.O
Udupi, Karnataka 576104
Country
India
Secondary sponsor category [1] 288566 0
Individual
Name [1] 288566 0
Rohith Krishna
Address [1] 288566 0
Assistant Professor
Department of Anaesthesiology
Kasturba Medical College, Madhav Nagar
Manipal.P.O
Udupi, Karnataka 576104
Country [1] 288566 0
India

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291609 0
Kasturba Hospital Institutional Ethics Committee
Ethics committee address [1] 291609 0
Institutional Ethics Committee
Kasturba Hospital, Manipal
Post box no. 7
Udupi, Karnataka-576104
Ethics committee country [1] 291609 0
India
Date submitted for ethics approval [1] 291609 0
Approval date [1] 291609 0
08/10/2013
Ethics approval number [1] 291609 0

Summary
Brief summary
Study is aimed at comparing the block characteristics of ultrasound guided supraclavicular brachial plexus block in 3 groups of patients. One group receiving plain ropivacaine (a local anaesthetic) without any additive, second group receiving ropivacaine with dexmedetomidine as additive and third group receiving ropivacaine with midazolam as additive. Previous studies suggest that additives prolong the duration of blockade. Our study is comparing two different additives.
Trial website
Trial related presentations / publications
Presented at 62nd annual national conference of Indian Society of Anaesthesiologists held at Madurai, Tamil Nadu, India.
Title: Ultrasound guided supraclavicular brachial plexus block using plain ropivacaine and ropivacaine with adjuvants.
Authors: Dr Sethulakshmi Prasad, Dr Shaji Mathew, Dr Rohith Krishna
Public notes

Contacts
Principal investigator
Name 49658 0
Dr Sethulakshmi Prasad
Address 49658 0
Room number: 220
Sonia hostel
Kasturba Medical College campus
Manipal .P.O
Udupi, Karnataka 576104
Country 49658 0
India
Phone 49658 0
+919901726835
Fax 49658 0
Email 49658 0
[email protected]
Contact person for public queries
Name 49659 0
Dr Rohith Krishna
Address 49659 0
Assistant Professor
Department of Anaesthesiology
Kasturba Medical College, Madhav Nagar
Manipal.P.O
Karnataka- 576104
Country 49659 0
India
Phone 49659 0
+919663378312
Fax 49659 0
Email 49659 0
[email protected]
Contact person for scientific queries
Name 49660 0
Dr Rohith Krishna
Address 49660 0
Assistant Professor
Department of Anaesthesiology
Kasturba Medical College, Madhav Nagar
Manipal.P.O
Karnataka- 576104
Country 49660 0
India
Phone 49660 0
+919663378312
Fax 49660 0
Email 49660 0
[email protected]

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