Institutional board and ethical committee approval were obtained (S-345678). Between August 2017 and July 2019, all patients with symptomatic uterine fibroids who accepted participation were block randomised were smaller blocks of fewer patients randomised to the two treatments at a time intending to have 20 patients in each group. The patients in one group had 1% 10 ml lidocaine (100 mg) administrated intra-arterially immediately after embolisation in each uterine artery, so the total doses given to each patient was 200 mg of lidocaine. In the other (control) group of patients, the procedure was performed according to standard principles without supplementary injection of lidocaine. The patient’s age and symptoms, fibroid number, localisation and total uterine and dominant fibroid volume changes before and after an embolization were analysed.
The standard embolisation technique was performed in local anaesthesia via either transfemoral or transradial access using diagnostic 5F catheter advanced into the internal iliac artery. Further, in all cases, micro-catheter (Direxion hi-flow 0.027- in., Boston scientific Massachusetts MA, USA) was used and advanced into the horizontal part of the uterine arteries. Embolisation with microspheres tris-acryl gelatin (500–900 μm) (Embosphere, Biosphere Medical, Paris, France) to near stasis defined as slow forward flow trough the main uterine artery with at least five heartbeats for clearance of contrast from uterine artery with the pruning of peripheral vessels. The total amount of the used microspheres was recorded and compared between the groups. All patients had patient-controlled analgesia pump (PCA) loaded with 2 mg morphine sulphate and an intermittent dose of 1 mg morphine with lockout intervals of 10 min. Before the beginning of the embolisation, a loading dose of 2 mg morphine was given to all patients. The patients were instructed to push the button of the PCA for the first time before the pain developed. No antibiotics were given and no urinary catheter was deployed. There was no standardised regimen concerning usage of adjunctive analgesia and sedation, and if needed, some patients take additional drugs such as non-steroid anti-inflammatory medications on the ward individually.
Inclusion criteria were symptomatic fibroids in a premenopausal woman with bleeding and/or bulky symptoms. Size and number of fibroids were not exclusion criteria. Patients who did not want to participate in the study were excluded. Allergy to morphine or lidocaine, heart block and active pelvic infection were exclusion criteria. After embolisation, the patients were transferred to the ward and a visual analogue pain scale (VAS) with oral and written instructions was given to the patients (Bijur et al. 2001). The patients marked their sensation of pain on the VAS at 2 h, 4 h, 7 h, 10 h and 24 h after embolisation. VAS schemes were collected the following day before discharge and the total amount of used morphine was registered as well. Three-month follow-up MRI control follow-up was scheduled for all the patients to investigate the infarction rate percentage using the description defined as fibroma infarction of 100%, 90–99%, or below 90% (Duvnjak et al. 2017). Infraction, less than 90% of total fibroid burden, was defined as insufficient.
Descriptive statistics were used for baseline patients and fibroid characteristics and were presented as number and percentage and as mean and standard deviation (SD). The student’s t-test was used for comparison between the groups regarding the used amount of morphine and pain experience. P-value < 0.05 was considered statistically significant. SPSS software package (Statistics 21, IBM Corporation, Armonk, NY, USA) program was used for analysis.