None listed
Conditions
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.
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 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 midwi
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.
Sponsors
University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to 60 Years
Healthy volunteers
No
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)
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.
Outcome results
None listed