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CLINICAL TRIAL
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
The effect of an intrauterine application of two percent lignocaine gel on pain perception during Vabra endometrial sampling: a randomised double-blind, placebo-controlled trial.
OBJECTIVE: To determine whether two percent lignocaine gel can reduce the perception of pain during Vabra endometrial aspiration.
DESIGN: Randomised, double-blind placebo-controlled trial.
SETTING: Women's Health Directorate, Warrington Hospital NHS Trust.
POPULATION: Women were referred to the endometrial sampling clinic for the investigation of pre and postmenopausal vaginal bleeding.
METHODS: Randomisation to either pre-sampling intrauterine two percent lignocaine gel or an inert gel. Patients, recruiters and assessors were blinded to the gel used.
MAIN OUTCOME MEASURES: The difference between the study groups in the proportion of women who, after Vabra sampling, recorded a pain score of > or = 6 out of 10 on a visual analogue scale.
RESULTS: Three hundred and eight women were randomised, 284 (92%) completed a pain scale before and immediately after the procedure. After the procedure, 84 women (30%) recorded a pain score of > or = 6, 38 (26%) received anaesthetic and 46 (33%) an inert gel. The difference in the proportion of women recording a pain score of 6 or above between the two study groups was not significant (relative risk (RR) for the anaesthetic gel = 0.79 95% CI, 0.55, 1.14).
CONCLUSIONS: Intrauterine application of 2% lignocaine gel did not significantly reduce the frequency with which women experienced unacceptable levels of pain or anxiety during endometrial aspiration compared with placebo.
DESIGN: Randomised, double-blind placebo-controlled trial.
SETTING: Women's Health Directorate, Warrington Hospital NHS Trust.
POPULATION: Women were referred to the endometrial sampling clinic for the investigation of pre and postmenopausal vaginal bleeding.
METHODS: Randomisation to either pre-sampling intrauterine two percent lignocaine gel or an inert gel. Patients, recruiters and assessors were blinded to the gel used.
MAIN OUTCOME MEASURES: The difference between the study groups in the proportion of women who, after Vabra sampling, recorded a pain score of > or = 6 out of 10 on a visual analogue scale.
RESULTS: Three hundred and eight women were randomised, 284 (92%) completed a pain scale before and immediately after the procedure. After the procedure, 84 women (30%) recorded a pain score of > or = 6, 38 (26%) received anaesthetic and 46 (33%) an inert gel. The difference in the proportion of women recording a pain score of 6 or above between the two study groups was not significant (relative risk (RR) for the anaesthetic gel = 0.79 95% CI, 0.55, 1.14).
CONCLUSIONS: Intrauterine application of 2% lignocaine gel did not significantly reduce the frequency with which women experienced unacceptable levels of pain or anxiety during endometrial aspiration compared with placebo.
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