Anesthetic Cream Use During Office Pessary Removal and Replacement: A Randomized Controlled Trial

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Abstract

OBJECTIVE:

To estimate the effect of lidocaine–prilocaine cream on patient pain at the time of office pessary removal and reinsertion.

METHODS:

In this double-blind, randomized placebo-controlled trial, participants undergoing routine pessary care in a urogynecology office at a tertiary referral center were randomized to application of 4 g of either lidocaine–prilocaine or placebo cream 5 minutes before pessary change. Visual analog scale pain scores were collected from the patient at baseline, after pessary removal, and after pessary reinsertion. Physicians also recorded their estimate of patient pain at pessary removal and reinsertion. The primary outcome was the participant-reported visual analog scale pain score at the time of pessary removal and reinsertion. A sample size of 26 per group (n=52) was planned to estimate an absolute mean difference in visual analog scale pain of 2.1 cm at the time of pessary removal. An analysis of covariance was used to evaluate pain at removal and reinsertion as a function of treatment assignment controlling for baseline pain.

RESULTS:

From July 2015 through February 2016, 116 women were screened and 54 were recruited: 28 in the lidocaine–prilocaine cream group and 26 in the placebo group. One patient in the lidocaine-prilocaine cream group was later withdrawn owing to vaginal erosion. The participants were all postmenopausal women, with an average age of 77.8 years. Most characteristics were similar between groups. After adjusting for baseline pain, participants randomized to the lidocaine–prilocaine group had lower pain at pessary removal when compared with those assigned to placebo (mean difference=−2.05, 95% confidence interval −3.69 to −0.41; P=.015).

CONCLUSION:

Lidocaine–prilocaine cream use at the time of office pessary removal reduces patient-reported pain. Clinicians may wish to include this simple intervention to optimize patient comfort and compliance.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov, NCT02380742.

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