Preemptive analgesia with the spinal anesthesia allows to decrease pain in hemorrhoidectomy postoperative period. The purpose of this study is to assess the effectiveness of the use of preemptive analgesia with spinal anesthesia to decrease postoperative pain and the amount of used analgesics including opioids.
Hemorrhoidectomy, as has being demonstrated to be an effective method of treatment for stage III-IV hemorrhoidal disease. However it is associated with intense postoperative pain that requires the use of multimodal analgesia. Inadequate pain control leads to the prolongation of admission, increasing the consumption of opioid analgesics, patients dissatisfaction with treatment. According to international guidelines of pain management the target level of postoperative pain should be 3-4 or less Visual Analogue Score (VAS) points. The multimodal analgesia including Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), acetaminophen and local anaesthetics are used to reach this aim. However, there are data on effectiveness of preemptive analgesia in anorectal surgery. Preemptive analgesia allows decreasing pain in postoperative period after hemorrhoidectomy. Ketoprophenum is used as an preemptive analgetic agent 1 hour prior to procedure. The aim of this prospective, randomized, double-blind study is to assess the effectiveness of the use of preemptive analgesia with Ketoprophenum 10 mg 2 hours before procedure per os with spinal anaesthesia to decrease postoperative pain and the amount of used analgesics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
144
The patient receives spinal anaesthesia and is placed in lithotomy position. A complex of external and internal haemorrhoid or internal haemorrhoid only is excised with monopolar electrocautery or bipolar electrosurgery device. Haemorrhoid pedicle is tied with absorbable polyfilament suture. One, two or three nodes can be removed per a procedure.
Ketoprophenum
Placebo
Clinic of Colorectal and Minimally Invasive Surgery
Moscow, Russia
RECRUITINGThe frequency of opioid analgesics usage
The frequency of opioid administration per day
Time frame: 0-7 days postoperatively
Severity of pain
The severity of the pain syndrome before defecation and after defecation reported by the patient according to Visual Analogue Score (VAS), where 0 - the minimum pain, 10 - the worst pain.
Time frame: 6, 12 and 24 hours after the operation, then 2 times per day up to 7th postoperative day
Duration of other analgesics usage
The duration in days of systemic and topical analgesics usage
Time frame: 0-7 days postoperatively
Frequency of other analgesics usage
Times per day of systemic and topical analgesics usage
Time frame: 0-7 days postoperatively
Re-admission rate
The rate of patients who were re-admitted due to refractory pain
Time frame: 30 days postoperatively
Overall quality of life
Assessed with patient-reported questionnaire Short Form 36 (SF-36). A total score in each of 8 sections will be calculated and transformed into a 0-100 scale with a score of zero equivalent to maximum disability and a score of 100 equivalent to no disability
Time frame: 7th and 30th days postoperatively
Returning to work
The period of time in days from the operation to returning to work
Time frame: 30 days postoperatively
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The rate of early postoperative complications
The rate of complications: bleeding, retention of urine, infectious complications in early postoperative period
Time frame: 0-30 days postoperatively