Paracervical Block for Laminaria Insertion Before Second-Trimester Abortion: A Randomized Controlled Trial

Abstract

Objective: To evaluate the efficacy of a paracervical block to decrease pain during osmotic dilator insertion before second-trimester abortion.

Methods: In this double-blind, randomized trial, 41 women undergoing Laminaria insertion before a second-trimester abortion received either a paracervical block with 18 mL 1% lidocaine and 2 mL sodium bicarbonate or a sham block. Women were between 14 and 23 6/7 weeks of gestation. The primary outcome was pain immediately after insertion of Laminaria. Women assessed their pain on a 100-mm visual analog scale. Secondary outcomes included assessment of pain at other times during the insertion procedure and overall satisfaction with pain control. To detect a 25-mm difference in pain immediately after Laminaria insertion, at an α of 0.05 and 80% power, we aimed to enroll 20 patients in each arm.

Results: From May 2015 to December 2015, 20 women received a paracervical block and 21 received a sham block. Groups were similar in demographics, including parity, history of surgical abortion, and number of Laminaria placed. The paracervical block reduced pain after Laminaria insertion (median scores 13 mm [interquartile range 2-39] compared with 54 mm [interquartile range 27-61], P=.01, 95% CI -47.0 to -4.0). Women who received a paracervical block also reported higher satisfaction with overall pain control throughout the entire Laminaria insertion procedure (median scores 95 mm [interquartile range 78-100] compared with 70 mm [interquartile range 44-90], P=.05, 95% CI 0.0-37.0).

Conclusion: Paracervical block is effective at reducing the pain of Laminaria insertion. Additionally, a paracervical block increases overall patient satisfaction with pain control during Laminaria placement.

Clinical trial registration: ClinicalTrials.gov, NCT02454296.

Conflict of interest statement

Financial Disclosure

Reni Soon, Jennifer Salcedo, and Bliss Kaneshiro receive research support from Merck, Mithra Pharmaceuticals, Gynuity Health Projects, and Contramed. The other authors did not report any potential conflicts of interest.

Each author has indicated that he or she has met the journal’s requirements for authorship.

Figures

Figure 1

Study flow diagram.

Figure 2

Distribution of pain scores during Laminaria insertion procedure and 15 minutes after insertion procedure. All comparisons analyzed using Wilcoxon rank sum test. Colored boxes indicate 25%–75% interquartile range, lines indicate nonoutliers, and diamonds indicate outliers.