Abstract
Objective
To evaluate whether intrauterine mepivacaine instillation before intrauterine device
(IUD) insertion decreases pain compared to placebo.
Study design
We performed a double-blind, randomized, controlled trial comparing mepivacaine 1%
10 mL versus 0.9% NaCl intrauterine instillation using a hydrosonography catheter
5 min before IUD insertion in women 18 years of age or older. Participants completed
a series of 10-cm visual analogue scales (VAS) to report pain during the procedure.
The primary outcome was the difference in VAS scores with IUD insertion between intervention
group and placebo. Secondary outcomes included VAS before and after insertion and
analgesia method acceptability.
Results
We randomized 86 women in a 1:1 ratio; both groups had similar baseline characteristics.
In the intention-to-treat analysis, the primary outcome, median VAS with IUD insertion,
was 4.8 cm in the intervention group [n=41, interquartile range (IQR) =3.1–5.8] and 5.9 cm in the placebo group (n=40, IQR=3.3–7.5, p=.062). In the per-protocol analysis, the median VAS with IUD insertion
was 4.8 cm (IQR=3.1–5.5) and 6.0 cm (IQR=3.4–7.6) for the intervention and placebo
groups, respectively (p=.033). More women in the intervention group reported the procedure
as easier than expected (n=26, 63.4% vs. n=15, 37.5%), and fewer reported it as worse than expected (n=3, 7.3% vs. n=14, 35%, p=.006).
Conclusion
Intrauterine mepivacaine instillation before IUD insertion modestly reduces pain,
but the effect size may be clinically significant.
Implications statement
While the reduction in VAS pain scores did not meet our a priori difference of 1.3
points for clinical significance, participants' favorable subjective reaction suggests
that this approach merits further study.
Keywords
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Article info
Publication history
Published online: March 01, 2019
Accepted:
February 8,
2019
Received in revised form:
February 8,
2019
Received:
August 23,
2018
Footnotes
☆Funding: This study has been partly funded by The European Society of Contraception and Reproductive Health (grant #ESC P-2015-B-06).
☆☆Conflicts of interest: Helena Kopp Kallner reports personal fees from Bayer and MSD outside the submitted work. All other authors declare no conflicts of interest.
★Clinical trial registration: Clinicaltrials.gov, NCT 02078063.
Identification
Copyright
© 2019 Elsevier Inc. All rights reserved.
