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Intrauterine mepivacaine instillation for pain relief during intrauterine device insertion in nulliparous women: a double-blind, randomized, controlled trial
Karolinska institutet.ORCID iD: 0000-0003-2813-7642
(WHO Centre, Karolinska Institutet)
2019 (English)In: Contraception, ISSN 0010-7824, E-ISSN 1879-0518, Vol. 99, no 6, p. 335-39Article in journal (Refereed) Published
Abstract [en]

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.

Copyright © 2019 Elsevier Inc. All rights reserved.

KEYWORDS: 

Contraception; Intrauterine devices; Mepivacaine; Pain; VAS

Place, publisher, year, edition, pages
2019. Vol. 99, no 6, p. 335-39
Keywords [en]
Intrauterine devices, Contraception, Pain, VAS, Mepivacaine
National Category
Obstetrics, Gynecology and Reproductive Medicine
Identifiers
URN: urn:nbn:se:du-30254DOI: 10.1016/j.contraception.2019.02.003OAI: oai:DiVA.org:du-30254DiVA, id: diva2:1325713
Available from: 2019-06-17 Created: 2019-06-17 Last updated: 2019-06-18Bibliographically approved

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