Self-administrated vaginal 2% lidocaine in-situ gel for pain relief during copper intrauterine device insertion in women with previous caesarean delivery only: a randomised, double-blind placebo-controlled trial.

OBJECTIVE

To evaluate the analgesic effect of self-administered vaginal 2% lidocaine gel in pain relief during copper intrauterine device (IUD) insertion in women with previous caesarean delivery only.

METHODS

A Randomised, double-blind, placebo-controlled trial (Clinicaltrials.gov: NCT03166111) included reproductive-aged women who previously delivered only by caesarean section (CS) requesting Copper IUD insertion. Eligible women were recruited and randomised (1:1) to lidocaine gel vs. placebo. Each woman was supplied by a syringe filled with five ml lidocaine or placebo in-situ gel to be self-administered vaginally ten minutes before insertion. The primary outcome was the difference in pain scores during IUD placement using a 10-cm Visual Analogue Scale (VAS).

RESULTS

The final analysis included 216 women ( = 108 in each arm). Women in the Lidocaine gel group were more likely to report statistically significant lower pain scores during vulsellum application, uterine sound placement, and during IUD placement [Mean difference (95%CI) = 2.04 (1.66-2.42), 2.62 (2.20-3.04), and 2.57 (2.12-3.01), respectively,  = 0.0001]. A significantly lower IUD insertion score indicating easier insertion was reported in the lidocaine group ( = 0.004). Similarly, the duration of IUD insertion was significantly shorter in the lidocaine group ( = 0.008). There was a higher level of satisfaction in the lidocaine group (5.92 vs. 3.34) in the placebo group ( = 0.0001).

CONCLUSIONS

Self-administered vaginal lidocaine gel 10 min before copper IUD insertion is effective in pain reduction in women with previous caesarean delivery only.