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Trial registered on ANZCTR
Registration number
ACTRN12625000280404p
Ethics application status
Submitted, not yet approved
Date submitted
31/03/2025
Date registered
11/04/2025
Date last updated
11/04/2025
Date data sharing statement initially provided
11/04/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Does the use of sodium bicarbonate buffering of lignocaine reduce the pain associated with perineal infiltration prior to repair?
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Scientific title
Effect of sodium bicarbonate buffered lignocaine on perineal infiltration pain in women with a second-degree perineal injury following vaginal birth
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Secondary ID [1]
314086
0
None
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Universal Trial Number (UTN)
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Trial acronym
INFILTRATE trial
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Perineal suturing
336855
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Perineal infiltration
336856
0
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Condition category
Condition code
Reproductive Health and Childbirth
333332
333332
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0
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Childbirth and postnatal care
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Placebo controlled randomised trial
The intervention is 1% Lignocaine buffered with sodium bicarbonate for injection 8.4% at a ratio of 9:1. e.g. 18 mls of lignocaine mixed with 2 mls of sodium bicarbonate prior to infiltration. Perineal infiltration generally requires a volume of 20 mls, of which 18 mls will be 1% lignocaine and 2 mls sodium bicarbonate 8.4% Injections are provided 3- 5 minutes prior to the commencement of the repair. The injections will be provided by either a doctor or midwife accredited to perform perineal repairs. The case report form will collect data on the exact amout of solution injected in each anatomical layer, details on the depth and height of the wound (measured using a graded wound probe) and description of the repair undertaken.
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Intervention code [1]
330662
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Treatment: Drugs
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Comparator / control treatment
The control is 1% Lignocaine mixed with sodium chloride 0.9% (normal saline) at a ratio of 9:1. For example 18 mls of lignocaine mixed with 2mls of normal saline prior to infiltration.
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Control group
Placebo
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Outcomes
Primary outcome [1]
340907
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The mean difference in self-reported (visual analogue) pain scores of injection pain between intervention and control groups
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Assessment method [1]
340907
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Visual analogue Pain scale (VAS) is a 100-mm-long, ungraded vertical or horizontal line with the suggested endpoints ‘no pain’ (left) and ‘worst imaginable pain’ (right).
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Timepoint [1]
340907
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At time of injections
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Secondary outcome [1]
445420
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Change in feelings of anxiety during perineal repair procedure
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Assessment method [1]
445420
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Difference in VAS of anxiety experienced during perineal repair
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Timepoint [1]
445420
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Following completion of perineal repair
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Secondary outcome [2]
445419
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Change in pain for perineal repair procedure
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Assessment method [2]
445419
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Difference in VAS of pain experienced during perineal repair
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Timepoint [2]
445419
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Following completion of perineal repair
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Secondary outcome [3]
445421
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Clinical Assessment of healing
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Assessment method [3]
445421
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Visual assessment by midwife
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Timepoint [3]
445421
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14 days post birth
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Secondary outcome [4]
445422
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Experience with perineal healing and function asessed a composite outcome
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Assessment method [4]
445422
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The Australian pelvic floor questionnaire
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Timepoint [4]
445422
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Six to eight weeks post birth
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Eligibility
Key inclusion criteria
Birthing women or persons who have experienced an unassisted singleton cephalic vaginal birth at term without an epidural and with a second-degree perineal injury (vaginal mucosa, perineal muscle and perineal skin)
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Minimum age
16
Years
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Maximum age
60
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Experienced an episiotomy
• Use of an epidural, spinal or pudendal block during labour or birth
• Required an assisted birth
• Experienced a 3rd or 4th degree perineal injury
• Multiple pregnancy
• Malpresentation (breech, transverse, shoulder)
• Have a serious medical condition at onset of labour (e.g. severe hypertension, diabetes requiring insulin infusion)
• Infection or inflammation at the infiltration sites or complications that could cause bleeding at infiltration site e.g. Thrombocytopenia.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers (vials)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be prepared using permuted block sizes of 2 and 4.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Assuming a standard deviation of 2.5, 80% power and 2-sided alpha of 0.05, 45 patients in each arm, 90 in total, would be required to detect a mean difference of 1.5 between buffered and unbuffered lidocaine using a two-sample t-test assuming equal variance. Accounting for a 10% drop off a total of 100, 50 patients in each group would need to be recruited.
Categorical variables will be summarised by frequency and percent and continuous variables by mean and standard deviation (SD) or median and interquartile range (IQR). Categorical variables will be examined using Pearson’s Chi-squared test or Fisher’s Exact test and continuous variables by a Student t-test or Mann-Whitney U test. A two-sided p value < 0.05 will be considered significant. The primary outcome will be analysed using a Student t-test and the mean difference and 95% confidence intervals reported. Multivariable linear regression of the change in VAS will be used to explore if the estimated difference between groups changes after accounting for participant characteristics, wound characteristics, amount injected and additional use of analgesia prior to or during the procedure. To explore insensitivity of the pain changes to data missing at random, analyses will be repeated using multiple imputation. A p-value of 0.05 will be considered statistically significant.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
4/08/2025
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Actual
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Date of last participant enrolment
Anticipated
3/08/2026
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Actual
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Date of last data collection
Anticipated
2/11/2026
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment postcode(s) [1]
43857
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4029 - Royal Brisbane Hospital
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Funding & Sponsors
Funding source category [1]
318594
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Government body
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Name [1]
318594
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NHMRC Investigator grant
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Address [1]
318594
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Country [1]
318594
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Australia
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Primary sponsor type
University
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Name
University of Queensland
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Address
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Country
Australia
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Secondary sponsor category [1]
320993
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None
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Name [1]
320993
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Address [1]
320993
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Country [1]
320993
0
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
317195
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Metro North Health Human Research Ethics Committee A
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Ethics committee address [1]
317195
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https://metronorth.health.qld.gov.au/research/ethics-and-governance/human-research-ethics-committee
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Ethics committee country [1]
317195
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Australia
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Date submitted for ethics approval [1]
317195
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18/03/2025
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Approval date [1]
317195
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Ethics approval number [1]
317195
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Summary
Brief summary
The aim of this trial to determine if the addition of a small amount of sterile sodium bicarbonate to the lignocaine immediately prior to use will neutralise the acid preservative (buffering) and subsequently reduce the pain associated with the injection. Participants in this trial will be women who have had an unassisted vaginal birth of a cephalic singleton infant at term without an epidural and experienced a second degree perineal injury. Second degree perineal injures are the most common type following vaginal birth and are routinely sutured by either midwives or doctors. This will be a randomised placebo controlled trial. Prior to the injection of local anesthetic the lignocaine will be mixed with either sodium bicarbonate 8.4% (9:1) or the placebo control of sodium chloride 0.9% (normal saline). The addition of normal saline will not neutralise the effect of the acid preservative. The primary outcome for the study will be the difference in self reported pain scores of the injection.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
140306
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Dr Nigel Lee
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Address
140306
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Level 3 Chamberlain building University of Queensland St Lucia Queensland 4072
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Country
140306
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Australia
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Phone
140306
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+61 7 427231390
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Fax
140306
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Email
140306
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[email protected]
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Contact person for public queries
Name
140307
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Nigel Lee
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Address
140307
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Level 3 Chamberlain building University of Queensland St Lucia Queensland 4072
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Country
140307
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Australia
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Phone
140307
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+61 7 427231390
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Fax
140307
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Email
140307
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[email protected]
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Contact person for scientific queries
Name
140308
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Nigel Lee
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Address
140308
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Level 3 Chamberlain building University of Queensland St Lucia Queensland 4072
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Country
140308
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Australia
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Phone
140308
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+61 7 427231390
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Fax
140308
0
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Email
140308
0
[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Researchers
Conditions for requesting access:
•
Yes, conditions apply:
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Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
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Requires a scientifically sound proposal or protocol
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Requires approval by an ethics committee
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Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
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All de-identified individual participant data
What types of analyses could be done with individual participant data?
•
Systematic reviews and meta-analyses
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Studies exploring new research questions
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Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
•
Email of trial custodian, sponsor or committee:
[email protected]
Are there extra considerations when requesting access to individual participant data?
No
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.
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