Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000056190p
Ethics application status
Not yet submitted
Date submitted
25/10/2018
Date registered
15/01/2019
Date last updated
15/01/2019
Date data sharing statement initially provided
15/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Perineal Repair Trial. Comparing different types of local anaesthetic for perineal repair following childbirth
Scientific title
Local anaesthetic for perineal repair following vaginal delivery: A randomised controlled trial
Secondary ID [1] 296419 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Second degree vaginal-perineal tears following birth 310174 0
Condition category
Condition code
Reproductive Health and Childbirth 308923 308923 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomisation of local anaesthetic used for local infiltration prior to repair of second degree vaginal-perineal tears. Local anaesthetic (arm 1, arm 2 or arm 3) will be administered by local subcutaneous infiltration to the vagina and perineum on a once-only basis by the health professional performing the repair (midwife, or obstetric resident / registrar), immediately prior to performing the repair. Vaginal-perineal repair will then be conducted as per institutional protocols.
3 Arms:
Arm 1 - Lignocaine 1% - 20mls
Arm 2 - Ropivacaine 0.75% - 20mls
Arm 3 - Lignocaine 1% with adrenaline 1 in 200,000 - 20mls
Intervention code [1] 312747 0
Treatment: Drugs
Comparator / control treatment
Lignociane 1% - 20mls
Control group
Active

Outcomes
Primary outcome [1] 307890 0
Measured blood loss following perineal repair. Following the birth, drapes will be changed prior to commencement of infiltration of local anaesthetic for the perineal repair (as described in the Description of the Intervention field), so fresh drapes are used for the repair. At completion of the repair, drapes will be weighed to allow calculation of blood loss (i.e. total weight minus dry weight of drapes equals blood loss).
Timepoint [1] 307890 0
Completion of perineal repair
Secondary outcome [1] 353243 0
Pain perception assessed by visual analogue scales
Timepoint [1] 353243 0
Following perineal repair, at 1 hour, 4 hours and 24 hours
Secondary outcome [2] 353244 0
Total analgesic requirements in first 24 hours following birth.
This will be assessed by chart review conducted by the study coordinator more than 24 hours following perineal repair
Timepoint [2] 353244 0
24 hours following birth

Eligibility
Key inclusion criteria
Singleton pregnancy
Vaginal delivery
Second degree vaginal-perineal tear
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Epidural for delivery
Current illicit drug use
Coagulation disorder for use of anticoagulants
Major labial tears

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer-generated sequence
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
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/02/2019
Actual
Date of last participant enrolment
Anticipated
1/08/2019
Actual
Date of last data collection
Anticipated
2/08/2019
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 301023 0
Hospital
Name [1] 301023 0
Royal Women's Hospital
Country [1] 301023 0
Australia
Primary sponsor type
Hospital
Name
Royal Women's Hospital
Address
Royal Women's Hospital
20 Flemington Rd
Parkville
VIC 3053
Country
Australia
Secondary sponsor category [1] 300611 0
None
Name [1] 300611 0
Address [1] 300611 0
Country [1] 300611 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 301778 0
Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 301778 0
Royal Women's Hospital
20 Flemington Rd
Parkville
VIC 3053
Ethics committee country [1] 301778 0
Australia
Date submitted for ethics approval [1] 301778 0
31/10/2018
Approval date [1] 301778 0
Ethics approval number [1] 301778 0

Summary
Brief summary
A single blinded, randomised controlled trial in women who sustain second degree vaginal tears, to assess whether the use of either Ropivacaine or Lignocaine with Adrenaline infiltration prior to vaginal-perineal repair results in either reduced blood loss or reduced pain compared to standard treatment with lignocaine.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88074 0
Dr Stephen Cole
Address 88074 0
C/o Royal Women's Hospital
20 Flemington Rd
Parkville
VIC 3053
Country 88074 0
Australia
Phone 88074 0
+61 383452000
Fax 88074 0
Email 88074 0
[email protected]
Contact person for public queries
Name 88075 0
Dr Stephen Cole
Address 88075 0
C/o Royal Women's Hospital
20 Flemington Rd
Parkville
VIC 3053
Country 88075 0
Australia
Phone 88075 0
+61 383452000
Fax 88075 0
Email 88075 0
[email protected]
Contact person for scientific queries
Name 88076 0
Dr Stephen Cole
Address 88076 0
C/o Royal Women's Hospital
20 Flemington Rd
Parkville
VIC 3053
Country 88076 0
Australia
Phone 88076 0
+61 383452000
Fax 88076 0
Email 88076 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
Approval and consent has not been sought for sharing of data


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.