Results of preoperative application of micronised purified flavonoid fraction as part of a multimodal analgesic regimen in anorectal surgery: a prospective, randomised, placebo-controlled, double-blind study

Abstract

This study aims to assess the efficiency of micronised purified flavonoid fraction (MPFF) administration prior to open haemorrhoidectomy on postoperative pain severity reduction.Methods. The prospective clinical study involved patients with haemorrhoidal disease. Participants were randomly divided into two groups: the first one received 1000 mg of MPFF (Detralex®) 15 days before surgery, seven days after surgery, according to the acute haemorrhoid treatment scheme, and 1000 mg per day until 30 days after surgery; the second one received a placebo. The primary endpoint was the frequency of opioid intake.Results. The study included 182 participants (102 and 82 in the experimental and control group, respectively). Postoperative pain at rest and during defecation was significantly lower in the experimental group on days 6—9 postoperatively (p < 0.05). The use of opioids and other NSAIDs after surgery did not differ between groups. There was no significant difference between groups in side effects frequency and time to return to the usual lifestyle. As for the quality of life, the control group had significantly higher levels of self-care difficulty, anxiety and lingering pain/discomfort, being more likely to suffer from other persistent complaints.Conclusion. The preoperative administration of MPFF as analgesia has demonstrated safety and efficacy, effectively reducing postoperative pain in anorectal surgery while avoiding an increase in side effects. Hence, it is recommended for routine implementation in patient care as an essential component of multimodal analgesia during anorectal surgery.