Effect of Lidocaine Gel on Pain from Copper IUD Insertion: A Randomized Controlled Trial.

Abstract

Abstract: Background and Objectives: The copper bearing intrauterine device (IUD) is a long –term, reversible contraception method that is as effective as tubal sterilization. Its insertion pain or fear of it may make women hesitate to use an IUD. This study aimed to determine effect of lidocaine gel on pain from copper IUD insertion. Methods and Materials: This study done among 96 women who have IUD inserted at a health center in Tabriz. The subjects were allocated into three groups: In one group, lidocaine 2% gel and in second, lubricant gel was placed in the cervical canal by a sterile swab one minute before IUD insertion and the third group got no intervention. Permuted –block randomization (with random block sized of 6 and 9) were used for group assignment and concealed in sequentially numbered, sealed, opaque envelopes. For blinding and being sterile, the gels were already poured and numbered sequentially (from 101 to 164) based on allocation sequence into sterile containers. On the papers within the envelopes was written "no intervention" for subjects allocated in the group with no intervention or numbers 101-164 sequentially for the subjects allocated into the gel groups. One expert midwife inserted all the IUDs. After IUD insertion, pain during the insertion was measured using 0-10 cm visual analogue scale. The IUD inserter was unaware of treatment allocation type of the gels used for each subject in the gel groups and the subjects and the person assessing the pain was unaware of allocation in three groups. One way ANOVA, Kruskall, Wallis, unpaired t test, Mann –Whitney and Linear regression in SPSS 13 were used to identify effect of lidocaine gel on the pain. Results: Overall, the mean pain score was 3.5±1.8. In univariate analysis, there was no significant difference in pain scores between three groups. Comparison of frequencies and univariate analysis showed difference in some possible confounding factors between the groups. Therefore, we used linear regression model to determine any difference in the pain between the groups, controlling effect of the possible confounding factors including history of vaginal delivery, interval from the last delivery, situation of lactation, history of IUD insertion and the interval of cervix wash and pain assessment which had an association with the pain score (with p<0.2). The regression results also showed no significant effect of lidocaine gel on the insertion pain. The mean pain score in the lidocaine group was 0.39 less than in the control group but it was no significant (CI 95% of the difference: -1.3, 0.57). Conclusion: Use of 2% lidocaine gel and also use of lubricant gel into the cervical canal, one minute before putting on cervical tenaculum, has no effect on reducing overall pain during IUD insertion.