Hemorrhoidectomy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREHemorrhoidectomy
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.
DRUGKetoprophenum
Ketoprophenum
DRUGPlacebo
Placebo
Sponsors
Russian Society of Colorectal Surgeons
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Written informed consent. 2. Patients over 18 years. 3. Symptomatic grade III-IV haemorrhoids. 4. Planned surgery: Milligan-Morgan hemorrhoidectomy
Exclusion criteria
1. Patient's refusal to participate in the study. 2. Pregnancy. 3. Contraindication or technical inability to perform subarachnoid anaesthesia. 4. Decompensated somatic diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The frequency of opioid analgesics usage | 0-7 days postoperatively | The frequency of opioid administration per day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of other analgesics usage | 0-7 days postoperatively | The duration in days of systemic and topical analgesics usage |
| Frequency of other analgesics usage | 0-7 days postoperatively | Times per day of systemic and topical analgesics usage |
| Re-admission rate | 30 days postoperatively | The rate of patients who were re-admitted due to refractory pain |
| Severity of pain | 6, 12 and 24 hours after the operation, then 2 times per day up to 7th postoperative day | 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. |
| Returning to work | 30 days postoperatively | The period of time in days from the operation to returning to work |
| The rate of early postoperative complications | 0-30 days postoperatively | The rate of complications: bleeding, retention of urine, infectious complications in early postoperative period |
| Overall quality of life | 7th and 30th days postoperatively | 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 |
Countries
Russia
Contacts
Primary ContactTatiana Garmanova, PhD
Backup ContactDaniil Markaryan, PhD
Outcome results
None listed