Self‐administered vaginal lidocaine gel for pain management with intrauterine device insertion: a blinded, randomized controlled trial

Abstract

Background: A major barrier to intrauterine device use is fear of pain during insertion. Trials exploring analgesic interventions for intrauterine device insertion have yielded mixed results, and no standardized pain management guidelines currently exist for this procedure. In an abortion‐related study, self‐administered lidocaine gel over a prolonged time interval showed promise as a method of pain control. Objective(s): The objective of the study was to assess pain control with intrauterine device insertion after patient‐administered lidocaine gel compared with placebo. Study Design: We conducted a randomized, blinded trial of women undergoing levonorgestrel or copper intrauterine device insertion in an outpatient gynecology clinic between July 2016 and April 2017. Participants self‐administered either 20 mL of 2% lidocaine gel or placebo gel vaginally at least 15 minutes prior to intrauterine device insertion. No other analgesics were administered. The primary outcome was pain during intrauterine device insertion, measured on a 100‐mm visual analog scale (0 being no pain and 100 being worst pain imaginable). Secondary outcomes included anticipated and baseline pain and pain with speculum insertion and tenaculum placement. In a postprocedure questionnaire, participants reported acceptability of vaginal gel and willingness to wait for pain control. Median values were assessed because of the nonnormal distribution of visual analog scale scores using the Mann‐Whitney U test. Predictors of intrauterine device insertion pain were assessed using a multiple linear regression. Results: In total, 220 women were randomized and 215 were included in analysis (108 in lidocaine gel, 107 in placebo gel groups). Median (range) time from gel administration to speculum insertion was 21 (14–74) and 20 (12–43) minutes in the lidocaine and placebo groups, respectively (P = .13). The median pain scores during intrauterine device insertion were not significantly different: 65 (1–99) mm in the lidocaine group and 59 (5–100) mm in the placebo group (P = .09). Among secondary outcome time points, only median pain scores at speculum insertion were significantly different between the lidocaine and placebo groups (7 [0–81] mm vs 11 [0–80] mm, respectively; P = .046). Anticipated pain and menstrual pain were both predictors of pain with intrauterine device insertion. The majority of women in both groups found the amount of vaginal leakage following gel insertion to be acceptable (>80%). Ninety‐two percent of participants (n = 194) stated they would be willing to wait before intrauterine device placement for a potential analgesic effect. Conclusion: Self‐administered lidocaine gel at least 15 minutes before intrauterine device insertion does not appear to reduce pain compared with placebo but may help with speculum insertion. We found that women are willing to extend visit time to gain pain control. Self‐administration of local anesthetic is acceptable to patients and should be considered in future research.