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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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?
Scientific title
Effect of sodium bicarbonate buffered lignocaine on perineal infiltration pain in women with a second-degree perineal injury following vaginal birth
Secondary ID [1] 314086 0
None
Universal Trial Number (UTN)
Trial acronym
INFILTRATE trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perineal suturing 336855 0
Perineal infiltration 336856 0
Condition category
Condition code
Reproductive Health and Childbirth 333332 333332 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 330662 0
Treatment: Drugs
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.
Control group
Placebo

Outcomes
Primary outcome [1] 340907 0
The mean difference in self-reported (visual analogue) pain scores of injection pain between intervention and control groups
Timepoint [1] 340907 0
At time of injections
Secondary outcome [1] 445419 0
Change in pain for perineal repair procedure
Timepoint [1] 445419 0
Following completion of perineal repair
Secondary outcome [2] 445420 0
Change in feelings of anxiety during perineal repair procedure
Timepoint [2] 445420 0
Following completion of perineal repair
Secondary outcome [3] 445421 0
Clinical Assessment of healing
Timepoint [3] 445421 0
14 days post birth
Secondary outcome [4] 445422 0
Experience with perineal healing and function asessed a composite outcome
Timepoint [4] 445422 0
Six to eight weeks post birth

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)
Minimum age
16 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
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.

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)
numbered containers (vials)
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.
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 43857 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 318594 0
Government body
Name [1] 318594 0
NHMRC Investigator grant
Country [1] 318594 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 320993 0
None
Name [1] 320993 0
Address [1] 320993 0
Country [1] 320993 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317195 0
Metro North Health Human Research Ethics Committee A
Ethics committee address [1] 317195 0
Ethics committee country [1] 317195 0
Australia
Date submitted for ethics approval [1] 317195 0
18/03/2025
Approval date [1] 317195 0
Ethics approval number [1] 317195 0

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

Contacts
Principal investigator
Name 140306 0
Dr Nigel Lee
Address 140306 0
Level 3 Chamberlain building University of Queensland St Lucia Queensland 4072
Country 140306 0
Australia
Phone 140306 0
+61 7 427231390
Fax 140306 0
Email 140306 0
Contact person for public queries
Name 140307 0
Nigel Lee
Address 140307 0
Level 3 Chamberlain building University of Queensland St Lucia Queensland 4072
Country 140307 0
Australia
Phone 140307 0
+61 7 427231390
Fax 140307 0
Email 140307 0
Contact person for scientific queries
Name 140308 0
Nigel Lee
Address 140308 0
Level 3 Chamberlain building University of Queensland St Lucia Queensland 4072
Country 140308 0
Australia
Phone 140308 0
+61 7 427231390
Fax 140308 0
Email 140308 0

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:
Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
Requires a scientifically sound proposal or protocol
Requires approval by an ethics committee
Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
All de-identified individual participant data
What types of analyses could be done with individual participant data?
Systematic reviews and meta-analyses
Studies exploring new research questions
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.