RecruitingPhase 3ACTRN12625000280404

Does the use of sodium bicarbonate buffering of lignocaine reduce the pain associated with perineal infiltration prior to repair?

Effect of sodium bicarbonate buffered lignocaine on perineal infiltration pain in women with a second-degree perineal injury following vaginal birth


Sponsor

University of Queensland

Enrollment

100 participants

Start Date

Dec 10, 2025

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 16 YearssMax Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

When someone gives birth and needs stitches for a perineal tear (a tear to the area between the vagina and the anus), a local anaesthetic injection is given first to numb the area. This injection can itself be painful because the local anaesthetic solution is slightly acidic. This study is testing whether adding a small amount of sodium bicarbonate (a common, safe compound) to the anaesthetic solution before it is injected can reduce the sting of that injection. Participants will be randomly assigned to receive either the buffered (with bicarbonate) or the standard (with saline) solution before their stitches, and will rate the pain of the injection on a scale. Neither the participant nor the midwife or doctor giving the injection will know which solution is being used. You may be eligible if you are a woman who has had an unassisted vaginal birth at term with a second-degree perineal tear, without using an epidural or spinal block. Women who had an assisted birth (forceps or vacuum), a more severe tear (third or fourth degree), an episiotomy, or a multiple pregnancy are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 bicar

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.


Locations(1)

QLD, Australia

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ACTRN12625000280404