Aim: To assess the efficiency of the micro-flavonoid fraction (MMF) administration prior to anorectal surgery with spinal anesthesia on postoperative pain severity reduction. Methods: Patients who meet the following criteria are included: participants must be diagnosed with surgical treatment of anorectal diseases. All participants are randomly divided into 2 groups: the first one gets a tablet with 1000 mg MFF (Detralex®), the second one gets a tablet containing starch per os 14 days before surgery (72 participants per arm). Then patients of each group will continue MFF administration for 30 days after surgery. Patients of both arms receive spinal anesthesia and undergo surgery. Following the procedure the primary and secondary outcomes are evaluated: frequency of the opioid drugs intake, the severity of the postoperative pain syndrome, duration and frequency of other drugs intake, readmission rate, overall quality of life, time from the procedure to returning to work and the complications rate, C-reactive protein level. Discussion: the MFF intake allows reducing the severity of the hemorrhoidal disease symptoms during conservative treatment. In addition, the Detralex® efficacy has been proven in postoperative pain reduction for patients diagnosed with varicose veins of the lower extremities. The investigators intend to evaluate the feasibility of the preoperative MFF administration for the postoperative pain reduction and the decrease of the postoperative complications in patients with hemorrhoidal disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
182
Patients of the experimental group received Detralex® 1000 mg QD for 15 days before the operation, 3000 mg starting from day 1 after the surgery for 4 days, then 2000 mg for the next 3 days and 1000 mg till day 30 after surgery. Under spinal anesthesia appropriate surgical intervention was performed. After the surgery, the patient was given a questionnaire and a scale for assessing pain at rest and during defecation within the first 2 weeks after surgery. During the hospital stay, the nurse filled out a section on the drugs used; after discharge, the patient filled out this section for 7 days after the surgery. After 30 days, the side effects section was filled out, and the quality of life was assessed on days 7 and 30. Also, the patients indicated in a separate column on which day after the surgery they were able to return to normal living or go to work.
Lomonosov Moscow State University, Fundamental Medicine Faculty
Moscow, Russia
rate of prescribing opioid analgesics
the rate of prescribing opioid analgesics to prevent the pain from rising above VAS 5 after surgery
Time frame: 7 days after surgery
pain at rest and during defecation
The pain was assessed using a visual analogue scale (VAS, 0 to 10 points, where 10 is the maximum score).
Time frame: 15 days after surgery
other medications use
the need for other medications after surgery
Time frame: 7 days after surgery
readmission rate
Time frame: 30 days after surgery
The life quality rate
The overall quality of life was assessed using the EQ-5D patient questionnaire.
Time frame: 7 and 30 days
time from surgery to return to work
Time frame: during 30 days after surgery
complication rates
bleeding, urinary retention, infectious complications
Time frame: within 30 days after the procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.