Journal of minimally invasive gynecology
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J Minim Invasive Gynecol · May 2007
Randomized Controlled TrialIntrauterine lidocaine infusion for pain relief during saline solution infusion sonohysterography: a randomized, controlled trial.
To evaluate the efficacy of intrauterine lidocaine instillation in reducing patient discomfort during saline solution infusion sonohysterography (SIS). ⋯ Intrauterine lidocaine seems to be effective in decreasing pain in parous women undergoing SIS.
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Within the context of the new medical methodology of evidence-based medicine, the ethical issues of making the randomized, placebo-controlled, clinical trial part of the matrix of surgical procedure evaluation are discussed. Surgical trials with alternative research design less rigorous than the double-blind, placebo-controlled, randomized trial leave the alternative: implementing surgical procedures based on anecdotal evidence and weaker scientific research. ⋯ The placebo effect with surgery is so strong that "sham surgery" within the clinical trial context is essential and an appropriate component of the ethics of clinical research. A discussion of these issues is presented.