Contraception · 2020
A double-blind randomized trial comparing lidocaine spray and placebo spray anesthesia prior to cervical laminaria insertion.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Meyer Raanan, Cahan Tal, Yagel Itai, Afek Arnon, Derazne Estela, Bar-Shavit Yochai, Yuval Yefet, Admon Dahlia, Shina Avi
Аннотация
OBJECTIVE: To compare pain during laminaria insertion after lidocaine spray versus placebo spray anesthesia in women about to undergo a surgical abortion procedure.
STUDY DESIGN: A double blind, randomized, placebo-controlled trial of women at 12-24 weeks gestation one day prior to surgical uterine evacuation procedure. Participants received lidocaine 10% or placebo (saline 0.9%) spray to the endocervix and ectocervix two minutes before laminaria insertion. The primary outcome was participants' pain score immediately after initial laminaria insertion, measured using a 10 cm visual analog scale (VAS). Secondary outcomes included scores at speculum removal and 15 min after speculum insertion.
RESULTS: From 7/2016 through 8/2018, we enrolled 68 and 66 women to the lidocaine and placebo groups, respectively. Baseline characteristics were similar in both groups. The primary outcome did not differ between lidocaine and placebo groups (median VAS 2.0 vs. 2.0 respectively, p = 0.69). Reported VAS after speculum removal and 15 min from speculum insertion were similar in the lidocaine and placebo groups (median 2.0, p = 0.99; median 1.0 vs. 1.5 respectively, p = 0.32). In multivariate analyses, lidocaine use was associated with decreased VAS score at 15 min from speculum insertion [95%CI -0.96 (-1.74 to -0.18), p = 0.016]. Reported VAS ≥7 at 1st laminaria insertion did not differ between lidocaine and placebo groups (5.88% vs. 10.61% respectively, p = 0.362).
CONCLUSION: In women scheduled for laminaria insertion prior to surgical uterine evacuation at 12-24 weeks gestation, topical application of lidocaine spray to the cervix before insertion did not result in lower reported pain as compared with placebo.
IMPLICATIONS: Our results imply that physicians should not use topical application of lidocaine spray to the cervix before laminaria insertion to reduce women's pain. Continued efforts must be made to find means to relieve pain by using simple, effective analgesia or adjusting the technique, and not using a tenaculum whenever possible.
STUDY DESIGN: A double blind, randomized, placebo-controlled trial of women at 12-24 weeks gestation one day prior to surgical uterine evacuation procedure. Participants received lidocaine 10% or placebo (saline 0.9%) spray to the endocervix and ectocervix two minutes before laminaria insertion. The primary outcome was participants' pain score immediately after initial laminaria insertion, measured using a 10 cm visual analog scale (VAS). Secondary outcomes included scores at speculum removal and 15 min after speculum insertion.
RESULTS: From 7/2016 through 8/2018, we enrolled 68 and 66 women to the lidocaine and placebo groups, respectively. Baseline characteristics were similar in both groups. The primary outcome did not differ between lidocaine and placebo groups (median VAS 2.0 vs. 2.0 respectively, p = 0.69). Reported VAS after speculum removal and 15 min from speculum insertion were similar in the lidocaine and placebo groups (median 2.0, p = 0.99; median 1.0 vs. 1.5 respectively, p = 0.32). In multivariate analyses, lidocaine use was associated with decreased VAS score at 15 min from speculum insertion [95%CI -0.96 (-1.74 to -0.18), p = 0.016]. Reported VAS ≥7 at 1st laminaria insertion did not differ between lidocaine and placebo groups (5.88% vs. 10.61% respectively, p = 0.362).
CONCLUSION: In women scheduled for laminaria insertion prior to surgical uterine evacuation at 12-24 weeks gestation, topical application of lidocaine spray to the cervix before insertion did not result in lower reported pain as compared with placebo.
IMPLICATIONS: Our results imply that physicians should not use topical application of lidocaine spray to the cervix before laminaria insertion to reduce women's pain. Continued efforts must be made to find means to relieve pain by using simple, effective analgesia or adjusting the technique, and not using a tenaculum whenever possible.