SALUD: self-administered lidocaine gel for pain management with uterine devices (IUD and EMB): A randomized trial
Contraception
Awarded 2016
Complex Family Planning Fellowship Research
Jennifer Conti, MD, MS
Stanford University
$34,452

Building off of previous research that showed a benefit to self-administered lidocaine gel prior to surgical abortion (my primary fellowship project), we sought to determine if the same approach (patient-applied vaginal lidocaine gel) would help decrease pain with other similar gynecologic procedures.
The objective of this study was to compare pain control at various time points during IUD insertion and EMB procedures using a locally applied, patient-administered lidocaine gel as compared to placebo. We hypothesized that patients who received lidocaine gel would have pain control that was superior to that of a placebo gel.
 
We conducted a double-blinded, superiority randomized controlled trial of women undergoing either of these procedures in an outpatient clinic setting. Participants were randomized to receive 20 ml of a self-administered, 2% lidocaine gel or placebo vaginal gel, 15 minutes before procedure initiation. No other pain medications were administered. We then measured participants’ pain scores at several time points throughout the procedure using a visual analog pain scale (VAS), and these numbers were compared between the two groups.
 
To date, the IUD arm of our study is complete, however we are still enrolling for the EMB portion. In the IUD arm, we enrolled 220 women and found that there were no differences in the average pain scores between groups at our primary outcome time point (time of speculum removal, or procedure completion). Likewise, there was no statistically significant difference in mean pain scores at any of the other time points measured throughout the procedure, except for with speculum insertion, where participants in the lidocaine gel group experienced significantly less pain.
 
These findings show that a self-administered lidocaine gel prior to IUD insertion does not appear to reduce pain more than placebo alone. It does however, show that lidocaine gel provides better pain control with speculum insertion and can be considered as an alternative, non-invasive approach for these procedures.
 

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