Mehmet Güney1, Baha Oral, Tamer Mungan. 1. Department of Obstetrics and Gynecology, Faculty of Medicine, Süleyman Demirel University, Isparta, Turkey. mguney@med.sdu.edu.tr
Abstract
OBJECTIVE: To evaluate the efficacy of intrauterine lidocaine instillation in reducing patient discomfort during the removal of a "lost" intrauterine device (IUD). METHODS: This double-blinded, randomized, placebo-controlled trial included 68 women who underwent removal procedure for a "lost" IUD. Thirty-four women were allocated to the lidocaine group and 34 to the saline group. The main outcome measure was the intensity of pain during, immediately after, and 20 minutes after the procedure, assessed by a visual analog scale. Statistical analysis was performed using the Friedman test with Bonferroni correction, Student t test, and chi2. RESULTS: There were no statistically significant differences between the study group and the control group in mean age, parity history of chronic pelvic pain and dysmenorrhea, history of curettage, education, socioeconomic status, menopausal status, breastfeeding, type of IUD, and duration of IUD. Pain scores demonstrated a significant difference between groups during the procedure (placebo 6.41 +/- 1.15, lidocaine 5.23 +/- 0.69, P < .01), immediately after procedure (placebo 6.05 +/- 1.01, lidocaine 4.94 +/- 0.60, P < .01), and 20 minutes after procedure (placebo 4.32 +/- 0.63, lidocaine 4.44 +/- 0.66, P < .01). The number needed to treat was 3 (95% confidence interval 2-9). CONCLUSION:Intrauterine lidocaine appears to be effective in decreasing pain in women undergoing the removal procedure of a "lost" IUD. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, NCT00308841. LEVEL OF EVIDENCE: I.
RCT Entities:
OBJECTIVE: To evaluate the efficacy of intrauterine lidocaine instillation in reducing patient discomfort during the removal of a "lost" intrauterine device (IUD). METHODS: This double-blinded, randomized, placebo-controlled trial included 68 women who underwent removal procedure for a "lost" IUD. Thirty-four women were allocated to the lidocaine group and 34 to the saline group. The main outcome measure was the intensity of pain during, immediately after, and 20 minutes after the procedure, assessed by a visual analog scale. Statistical analysis was performed using the Friedman test with Bonferroni correction, Student t test, and chi2. RESULTS: There were no statistically significant differences between the study group and the control group in mean age, parity history of chronic pelvic pain and dysmenorrhea, history of curettage, education, socioeconomic status, menopausal status, breastfeeding, type of IUD, and duration of IUD. Pain scores demonstrated a significant difference between groups during the procedure (placebo 6.41 +/- 1.15, lidocaine 5.23 +/- 0.69, P < .01), immediately after procedure (placebo 6.05 +/- 1.01, lidocaine 4.94 +/- 0.60, P < .01), and 20 minutes after procedure (placebo 4.32 +/- 0.63, lidocaine 4.44 +/- 0.66, P < .01). The number needed to treat was 3 (95% confidence interval 2-9). CONCLUSION:Intrauterine lidocaine appears to be effective in decreasing pain in women undergoing the removal procedure of a "lost" IUD. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, NCT00308841. LEVEL OF EVIDENCE: I.