Preemptive Analgesia for Hemorrhoidectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Preemptive Analgesia for Hemorrhoidectomy

Conditions
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Hemorrhoidectomy

Intervention / Treatment
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* Procedure: Hemorrhoidectomy
* Drug: Ketoprophenum
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent. Patients over 18 years. Symptomatic grade III-IV haemorrhoids. Planned surgery: Milligan-Morgan hemorrhoidectomy Exclusion Criteria: Patient's refusal to participate in the study. Pregnancy. Contraindication or technical inability to perform subarachnoid anaesthesia. Decompensated somatic diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketoprophenum<br>A tablet with 10 mg Ketoprophenum is taken per os 2 hours before surgery | Procedure: Hemorrhoidectomy<br>* 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.<br>Drug: Ketoprophenum<br>* Ketoprophenum<br>|
| Placebo Comparator: Placebo<br>A tablet containing starch is taken per os 2 hours before surgery | Procedure: Hemorrhoidectomy<br>* 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.<br>Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of opioid analgesics usage | The frequency of opioid administration per day | 0-7 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 0-7 days postoperatively | 
| Frequency of other analgesics usage | Times per day of systemic and topical analgesics usage | 0-7 days postoperatively | 
| Re-admission rate | The rate of patients who were re-admitted due to refractory pain | 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 | 7th and 30th days postoperatively | 
| Returning to work | The period of time in days from the operation to returning to work | 30 days postoperatively | 
| The rate of early postoperative complications | The rate of complications: bleeding, retention of urine, infectious complications in early postoperative period | 0-30 days postoperatively |