Abstract
Study question
Does Buscopan® reduce abdominal pain experienced by women undergoing ultrasound-guided manual vacuum aspiration (USG-MVA)?
Summary answer
The addition of 20mg Buscopan® intravenous injection was not associated with a statistical reduction in pain score but leads to a higher patient satisfaction score.
What is known already
Ultrasound-guided Manual Vacuum aspiration is a feasible and effective out-patient treatment option for treating early pregnancy loss. However, it is associated with a moderate amount of pain due to uterine contraction.
Study design, size, duration
This randomised, double-blinded, placebo-controlled trial was conducted in a university-affiliated tertiary hospital. The study assessed whether 1 ml of 20mg Buscopan® intravenous injection 5 minutes before the USG-MVA will reduce the abdominal pain experienced by the women immediately and 2 hours after the procedure. Participants were randomised between June 2018 to January 2020 using a computer-generated number series in a 1:1 ratio.
Participants/materials, setting, methods
Women aged 18 years or older with first-trimester miscarriage undergoing the USG-MVA procedure were eligible. In total, 122 participants out of 128 eligible were included. Of whom, 111 underwent the USG-MVA procedure, 60 randomised to the Buscopan® group, and 62 to the placebo group.
Main results and the role of chance
The median abdominal pain scores in the Buscopan® group were 16.0% and 21.2% lower than the placebo group immediately post-procedure and 2 hours after the procedure in the Buscopan® group. Repeated measures ANOVA indicated that the both vaginal and abdominal pain scores improved significantly with the time (Vaginal F(1,108)= 180.1,p<0.0001;
Abdominal
F(1,108)=83.41,p<0.001) but not with group. No difference was noted in the complications and side effects profile. The physiological stress measured by Log10 sAA levels reduced significantly with time (F(2.8,286.1)= 6.3, p < 0.001) but not with group (F = 0.1, p = 0.96). Women randomised to Buscopan® had a significantly higher (p = 0.032) mean VAS satisfaction scores compared to those receiving placebo (79.0±17.3 vs 73.4±24.1).
Limitations, reasons for caution
This study was a single-centre study, thus one should be cautious in the overall generalisability of the results.
Wider implications of the findings
Few studies have evaluated the use of anti-spasmodic agents to minimise uterine contraction pain in women undergoing outpatient uterine evacuation. We consider Buscopan® a useful adjunct in the pain control of USG-MVA to specifically reduce uterine cramps. Further larger studies are required to evaluate its efficacy
Trial registration number
ChiCTR1800014590