The reduced pain level lasted up to 9 months after the third treatment [17]. It is unclear how fast and in what amount the small dosage of lignocaine diffuses through the selleckchem peritoneum and reaches the blood after pertubation. In the above clinical study, serum samples were
therefore collected before and after the treatment for later analysis of lignocaine in serum. This observational study reports the serum concentration of lignocaine after pertubation of 10 mg lignocaine hydrochloride. The hypothesis is that the pertubated dosage of 10 mg lignocaine hydrochloride reaches the central circulation and gives rise to low systemic levels of lignocaine. 2 Methods 2.1 Study Design, Participants and Procedures A randomized, double-blind and controlled study was conducted SC79 research buy to study check details the effect of pertubation with lignocaine (1 mg/ml, 10 ml) on dysmenorrhoea and quality of life. A total of 42 patients were included in the study, 24 of whom were randomized to active treatment and 18 to placebo. The methods of this trial have previously been described in detail [17]. The patients were recruited through advertisements and from the gynaecological outpatient unit at the three participating clinics in Stockholm, Sweden. The first patient was included in March 2007 and the last in November
2008. The main inclusion criteria were presence of peritoneal or ovarian endometriosis cAMP inhibitor verified by laparoscopy and dysmenorrhoea, with a pain score of >50 mm on the visual analogue scale (VAS). The exclusion criteria included reduced patency in the fallopian tubes and the intention to achieve pregnancy during the forthcoming year. Detailed eligibility criteria for the study have been previously published [17]. Written informed consent was obtained before any study-related procedures, and the CONSORT (Consolidated Standards of Reporting Trials) guidelines were followed. The procedure was approved by the Medical Products Agency in Sweden, 8
November 2006 (151:2006/56028) and after amendment, 12 December 2007 (151:2007/76934), as well as by the Regional Ethical Review Board in Stockholm, 10 January 2007 (2006/1416-32) and after amendment, 14 December 2007 (2007/1398-32). Before inclusion, the patients were scrutinized and tested concerning all criteria. Three treatments were given pre-ovulatory on cycle day 6–12 in three sequential menstrual cycles, since the effect on dysmenorrhoea increased after repeated treatments [7]. A thin plastic catheter (PBN-Medicals, Stenløse, Denmark) was inserted and cuffed in the cervical canal or in the caudal part of the uterine cavity; 10 ml of ringer-lignocaine 1 mg/ml (active treatment) or ringer acetate (placebo) was infused through the uterine cavity and pertubated into the peritoneal cavity.