Mehmet Guney1, Baha Oral, Gokhan Bayhan, Tamer Mungan. 1. Department of Obstetrics and Gynecology, Faculty of Medicine, Suleyman Demirel University, Isparta, Turkey. mguney@med.sdu.edu.tr
Abstract
STUDY OBJECTIVE: To evaluate the efficacy of intrauterine lidocaine instillation in reducing patient discomfort during saline solution infusion sonohysterography (SIS). DESIGN: A double-blinded, randomized, controlled trial (Canadian Task Force classification I). SETTING:Suleyman Demirel University School of Medicine, Department of Obstetrics and Gynecology, Isparta. PATIENTS: One hundred-six women who underwent SIS. INTERVENTIONS:Fifty-three patients were allocated to the lidocaine group and 53 to the saline solution group. MEASUREMENTS AND MAIN RESULTS: The main outcome measures were the intensity of pain during, immediately after, and 20 minutes after the procedure, assessed by a visual analog scale and the patients' distress evaluated by the physician with a 3-point observer scale. There were no statistically significant differences between the study group and the control group in mean age, parity, past cervical surgery, history of chronic pelvic pain and dysmenorrhea, history of curettage, education, socioeconomic status, menopausal status, volume of saline solution infused (mL), tenaculum use, and indication for SIS. Pain scores demonstrated a statistically significant difference between groups during the procedure (placebo 5.09 +/- 1.25 [95% CI 4.74-5.43], lidocaine 3.90 +/- 1.02 [95% CI 3.61-4.18], p <.001); immediately after procedure (placebo 4.03 +/- 0.89 [95% CI 3.78-4.27], lidocaine 3.16 +/- 0.67 [95% CI 2.97-3.34], p <.001); and 20 minutes after procedure (placebo 3.32 +/- 0.54 [95% CI 3.17-3.46], lidocaine 2.43 +/- 0.72 [95% CI 2.23-2.62], p <.001). No significant pain relief in nulliparous patients was obtained by the use of lidocaine (4.88 +/- 1.01 [95% CI 4.60-5.15], 3.88 +/- 0.86 [95% CI 3.64-4.11], 3.22 +/- 0.55 [95% CI 3.06-3.37], respectively; p >.05). Pain rated by the physician during, immediately after, and 20 minutes after the procedure was significantly different between the groups (p <.001), and a significant correlation was noted between the visual analog pain score and the patients' distress recorded by the physician (r = 0.816, r = 0.697, r = 0.676; p <.001, respectively). CONCLUSION:Intrauterine lidocaine seems to be effective in decreasing pain in parous women undergoing SIS.
RCT Entities:
STUDY OBJECTIVE: To evaluate the efficacy of intrauterine lidocaine instillation in reducing patient discomfort during saline solution infusion sonohysterography (SIS). DESIGN: A double-blinded, randomized, controlled trial (Canadian Task Force classification I). SETTING: Suleyman Demirel University School of Medicine, Department of Obstetrics and Gynecology, Isparta. PATIENTS: One hundred-six women who underwent SIS. INTERVENTIONS: Fifty-three patients were allocated to the lidocaine group and 53 to the saline solution group. MEASUREMENTS AND MAIN RESULTS: The main outcome measures were the intensity of pain during, immediately after, and 20 minutes after the procedure, assessed by a visual analog scale and the patients' distress evaluated by the physician with a 3-point observer scale. There were no statistically significant differences between the study group and the control group in mean age, parity, past cervical surgery, history of chronic pelvic pain and dysmenorrhea, history of curettage, education, socioeconomic status, menopausal status, volume of saline solution infused (mL), tenaculum use, and indication for SIS. Pain scores demonstrated a statistically significant difference between groups during the procedure (placebo 5.09 +/- 1.25 [95% CI 4.74-5.43], lidocaine 3.90 +/- 1.02 [95% CI 3.61-4.18], p <.001); immediately after procedure (placebo 4.03 +/- 0.89 [95% CI 3.78-4.27], lidocaine 3.16 +/- 0.67 [95% CI 2.97-3.34], p <.001); and 20 minutes after procedure (placebo 3.32 +/- 0.54 [95% CI 3.17-3.46], lidocaine 2.43 +/- 0.72 [95% CI 2.23-2.62], p <.001). No significant pain relief in nulliparous patients was obtained by the use of lidocaine (4.88 +/- 1.01 [95% CI 4.60-5.15], 3.88 +/- 0.86 [95% CI 3.64-4.11], 3.22 +/- 0.55 [95% CI 3.06-3.37], respectively; p >.05). Pain rated by the physician during, immediately after, and 20 minutes after the procedure was significantly different between the groups (p <.001), and a significant correlation was noted between the visual analog pain score and the patients' distress recorded by the physician (r = 0.816, r = 0.697, r = 0.676; p <.001, respectively). CONCLUSION:Intrauterine lidocaine seems to be effective in decreasing pain in parous women undergoing SIS.
Authors: Gena C Dunivan; Brent A Parnell; AnnaMarie Connolly; Mary L Jannelli; Bethany Jablonski Horton; Elizabeth J Geller Journal: Int Urogynecol J Date: 2011-02-12 Impact factor: 2.894