Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001772134
Ethics application status
Approved
Date submitted
25/11/2019
Date registered
13/12/2019
Date last updated
13/12/2019
Date data sharing statement initially provided
13/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of pain relief in Ropivacaine or Bupivacaine soaked dressing at split skin graft donor site.
Scientific title
Comparison of the Effectiveness of Ropivacaine Soaked Vs Bupivacaine Soaked Dressing for Pain Relief at Split Thickness Skin Graft Donor Site at Tertiary Care Hospital: A Randomized Control Trial
Secondary ID [1] 299896 0
Nil
Universal Trial Number (UTN)
U1111-1131-0755
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin graft 315317 0
Condition category
Condition code
Skin 313619 313619 0 0
Other skin conditions
Surgery 313620 313620 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In group A, the donor site of split skin graft was dressed (topical application only) with dressing soaked with 0.25% Ropivacaine as 12ml/100cm2 once only by a plastic surgeon and then documented in operation notes..
Intervention code [1] 316184 0
Treatment: Drugs
Comparator / control treatment
In group B, the donor site of split skin graft was dressed with dressing soaked with 0.25% Bupivacaine as 12ml/100cm2
Control group
Active

Outcomes
Primary outcome [1] 322075 0
Pain will be measured clinically with visual analog scale for pain from 0-10, where 0 will be no pain and 10 will be worst pain by a consultant Plastic Surgeon
Timepoint [1] 322075 0
It will be assessed after 4 hours of the procedure.
Secondary outcome [1] 377230 0
Infection will be assessed clinically by history of pain and presence of redness, swelling, raised temperature of surrounding skin on examination
Timepoint [1] 377230 0
will be assessed at one and two week post operative by consultant plastic surgeon

Eligibility
Key inclusion criteria
patients in which split skin graft is required for wound closure
Minimum age
16 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of Allergy to local anesthetic
Bleeding disorder
Anti coagulant therapy

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)
allocation involved contacting the holder of the allocation schedule who was "off-site"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a random number table from a statistic book
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/12/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 22143 0
Pakistan
State/province [1] 22143 0
Punjab

Funding & Sponsors
Funding source category [1] 304361 0
Hospital
Name [1] 304361 0
Jinnah Burn and Reconstructive Surgery Center, Lahore, Pakistan
Country [1] 304361 0
Pakistan
Primary sponsor type
Individual
Name
Farrukh Aslam Khalid
Address
Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Maulana Shaukat Ali Road. Lahore 54550
Country
Pakistan
Secondary sponsor category [1] 304609 0
None
Name [1] 304609 0
Address [1] 304609 0
Country [1] 304609 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304803 0
Institutional Ethical Review Board
Ethics committee address [1] 304803 0
Ethics committee country [1] 304803 0
Pakistan
Date submitted for ethics approval [1] 304803 0
05/11/2018
Approval date [1] 304803 0
10/12/2018
Ethics approval number [1] 304803 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98262 0
Dr Farrukh Aslam Khalid
Address 98262 0
Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Maulana Shaukat Ali Road. Lahore 54550
Country 98262 0
Pakistan
Phone 98262 0
+923009671600
Fax 98262 0
Email 98262 0
[email protected]
Contact person for public queries
Name 98263 0
Farrukh Aslam Khalid
Address 98263 0
Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Maulana Shaukat Ali Road. Lahore 54550
Country 98263 0
Pakistan
Phone 98263 0
+923009671600
Fax 98263 0
Email 98263 0
[email protected]
Contact person for scientific queries
Name 98264 0
Farrukh Aslam Khalid
Address 98264 0
Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Maulana Shaukat Ali Road. Lahore 54550
Country 98264 0
Pakistan
Phone 98264 0
+923009671600
Fax 98264 0
Email 98264 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The trial has no website. Data will be stored confidentially and will not be used for any further research unless further ethics approval is granted.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.