Baldomero Arnau1, Esther Jovell2, Marino Romero3, Manuela Gonzalez4, Lola Esteba5, Araceli Garcia5. 1. Department of Obstetrics and Gynaecology, Consorci Sanitari de Terrassa, Crta. Torrebonica s/n, 08227 Terrassa, Barcelona, Spain. Electronic address: barnau@cst.cat. 2. Department of Epidemiology, Consorci Sanitari de Terrassa, Barcelona, Spain. 3. Department of Obstetrics and Gynaecology, Consorci Sanitari de Terrassa, Crta. Torrebonica s/n, 08227 Terrassa, Barcelona, Spain. 4. Department of Pharmacy, Consorci Sanitari de Terrassa, Barcelona, Spain. 5. Department of Radiology, Consorci Sanitari de Terrassa, Barcelona, Spain.
Abstract
OBJECTIVE: The efficacy of lidocaine-prilocaine cream (EMLA(®)) analgesia in the practice of hysterosalpingography is controversial. This study provides new drill results and a new method of application in terms of mode, time and place. The aim of the paper is to investigate the efficacy of 5% lidocaine 25 mg-prilocaine 25 mg/g cream applied to the uterine cervix for reducing pain during hysterosalpingography. STUDY DESIGN: A randomized, double blinded, controlled study set in the general gynaecology clinic of a university teaching hospital between September 2012 and June 2013. One hundred successive patients programmed to undergo hysterosalpingography were randomized to either 3 ml of EMLA (50) cream or 3 ml of placebo (50), placed endocervically and exocervically, 10 min before hysterosalpingography. Patients' intensity of pain was assessed in four steps: at baseline (speculum application), after application of Pozzi tenaculum and cannula on the uterine cervix, during cervical traction and after contrast medium injection, using a 10-cm Visual Analogue Scale (VAS) immediately after the procedure. The most painful step was also identified. VAS was administered again at one-month follow-up visit. TRIAL REGISTRATION: NCT01303614. RESULTS: The contrast medium injection was the most painful step of hysterosalpingography in both groups (EMLA 3.96, placebo 4.54, 95%CI: -0.481 to 1.641). No differences were found between the two groups (P=0.281) during this step. When comparing the VAS scale after the application of Pozzi tenaculum and cannula (EMLA 1.06, placebo 3.34, 95%CI: 1.495-3.065) and after cervical traction (EMLA 2.54, placebo 3.46, 95%CI: 0.034-1.806), significantly less pain was experienced by the EMLA group than the placebo group: P=0.000 and P=0.042, respectively. CONCLUSION: Endocervical and exocervical topical application of EMLA 10 min before performing hysterosalpingography significantly reduced pain during cervical manipulation with tenaculum and cannula and during cervical traction, but did not reduce pain during injection of contrast that was the most painful step.
RCT Entities:
OBJECTIVE: The efficacy of lidocaine-prilocaine cream (EMLA(®)) analgesia in the practice of hysterosalpingography is controversial. This study provides new drill results and a new method of application in terms of mode, time and place. The aim of the paper is to investigate the efficacy of 5% lidocaine 25 mg-prilocaine 25 mg/g cream applied to the uterine cervix for reducing pain during hysterosalpingography. STUDY DESIGN: A randomized, double blinded, controlled study set in the general gynaecology clinic of a university teaching hospital between September 2012 and June 2013. One hundred successive patients programmed to undergo hysterosalpingography were randomized to either 3 ml of EMLA (50) cream or 3 ml of placebo (50), placed endocervically and exocervically, 10 min before hysterosalpingography. Patients' intensity of pain was assessed in four steps: at baseline (speculum application), after application of Pozzi tenaculum and cannula on the uterine cervix, during cervical traction and after contrast medium injection, using a 10-cm Visual Analogue Scale (VAS) immediately after the procedure. The most painful step was also identified. VAS was administered again at one-month follow-up visit. TRIAL REGISTRATION: NCT01303614. RESULTS: The contrast medium injection was the most painful step of hysterosalpingography in both groups (EMLA 3.96, placebo 4.54, 95%CI: -0.481 to 1.641). No differences were found between the two groups (P=0.281) during this step. When comparing the VAS scale after the application of Pozzi tenaculum and cannula (EMLA 1.06, placebo 3.34, 95%CI: 1.495-3.065) and after cervical traction (EMLA 2.54, placebo 3.46, 95%CI: 0.034-1.806), significantly less pain was experienced by the EMLA group than the placebo group: P=0.000 and P=0.042, respectively. CONCLUSION: Endocervical and exocervical topical application of EMLA 10 min before performing hysterosalpingography significantly reduced pain during cervical manipulation with tenaculum and cannula and during cervical traction, but did not reduce pain during injection of contrast that was the most painful step.