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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?

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]

None

Universal Trial Number (UTN)

Trial acronym

INFILTRATE trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Perineal suturing

Perineal infiltration

Condition category

Condition code

Reproductive Health and Childbirth

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]

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]

The mean difference in self-reported (visual analogue) pain scores of injection pain between intervention and control groups

Timepoint [1]

At time of injections

Secondary outcome [1]

Change in pain for perineal repair procedure

Timepoint [1]

Following completion of perineal repair

Secondary outcome [2]

Change in feelings of anxiety during perineal repair procedure

Timepoint [2]

Following completion of perineal repair

Secondary outcome [3]

Clinical Assessment of healing

Timepoint [3]

14 days post birth

Secondary outcome [4]

Experience with perineal healing and function asessed a composite outcome

Timepoint [4]

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?

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

4/08/2025

Actual

Date of last participant enrolment

Anticipated

3/08/2026

Actual

Date of last data collection

Anticipated

2/11/2026

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4029 - Royal Brisbane Hospital

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC Investigator grant

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

University of Queensland

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Metro North Health Human Research Ethics Committee A

Ethics committee address [1]

https://metronorth.health.qld.gov.au/research/ethics-and-governance/human-research-ethics-committee

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/03/2025

Approval date [1]

Ethics approval number [1]

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Nigel Lee

Address

Level 3 Chamberlain building University of Queensland St Lucia Queensland 4072

Country

Australia

Phone

+61 7 427231390

Fax

[email protected]

Contact person for public queries

Name

Nigel Lee

Address

Level 3 Chamberlain building University of Queensland St Lucia Queensland 4072

Country

Australia

Phone

+61 7 427231390

Fax

[email protected]

Contact person for scientific queries

Name

Nigel Lee

Address

Level 3 Chamberlain building University of Queensland St Lucia Queensland 4072

Country

Australia

Phone

+61 7 427231390

Fax

[email protected]

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?

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.

Trial Review

Documents added manually

Documents added automatically