Self-Administered Lidocaine Gel for Pain Control With First-Trimester Surgical Abortion: A Randomized Controlled Trial: Correction.

OBJECTIVE To compare pain control at various time points during first-trimester surgical abortion using a patient-administered lidocaine gel compared with a traditional lidocaine paracervical block. METHODS We conducted a randomized controlled trial of women undergoing surgical abortion at less than 12 weeks of gestation in an outpatient setting. The primary outcome was pain at cervical dilation as measured on a 100-mm visual analog scale. A sample size of 142 participants was planned to detect a 15-mm or greater difference on the 100-mm visual analog scale with 90% power and a significance level of .025, adding 10% for participant dropout and protocol violations. Participants received either 12 mL of a 1% lidocaine paracervical block or 20 mL of a self-administered, 2% lidocaine gel 20-30 minutes before procedure initiation. Secondary outcomes included anticipated pain, baseline pain, pain with speculum and tenaculum placement, pain after suction aspiration, and pain 30-45 minutes postoperatively. RESULTS From April to October 2015, a total of 142 women were enrolled (68 in the paracervical block group, 69 in the gel group, and five not analyzed as a result of participant withdrawal). Sociodemographic characteristics were similar between groups. The mean pain score with cervical dilation was 60 mm (95% confidence interval [CI] 54-66) in the paracervical block group and 64 mm (95% CI 59-69) in the gel group (P=.3). There was no significant difference between mean pain scores at any time points measured. CONCLUSION Self-administration of lidocaine gel before first-trimester surgical abortion is noninferior to a traditional paracervical lidocaine block and should be considered as an alternative, noninvasive approach to pain control for first-trimester surgical abortion. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, https://clinicaltrials.gov, NCT02447029.