Preemptive Analgesia for Hemorrhoidectomy

Not Applicable

• Conditions: Hemorrhoidectomy
• Interventions: Procedure: Hemorrhoidectomy; Drug: Ketoprophenum; Drug: Placebo

• Registration Number: NCT04361695
• Lead Sponsor: Russian Society of Colorectal Surgeons

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.

Study Timeline

• Study Start: 2020-02-27
• Study First Submitted: 2020-03-26
• Status Verified: 2020-04
• Study First Submitted QC: 2020-04-23
• Last Update Submitted: 2020-04-23
• Study First Posted: 2020-04-24
• Last Update Posted: 2020-04-24
• Primary Completion: 2021-02-25
• Study Completion: 2022-08-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketoprophenum	Hemorrhoidectomy	A tablet with 10 mg Ketoprophenum is taken per os 2 hours before surgery
Ketoprophenum	Ketoprophenum	A tablet with 10 mg Ketoprophenum is taken per os 2 hours before surgery
Placebo	Hemorrhoidectomy	A tablet containing starch is taken per os 2 hours before surgery
Placebo	Placebo	A tablet containing starch is taken per os 2 hours before surgery

Primary Outcome Measures

Name	Time	Method
The frequency of opioid analgesics usage	0-7 days postoperatively	The frequency of opioid administration per day

Secondary Outcome Measures

Name	Time	Method
Frequency of other analgesics usage	0-7 days postoperatively	Times per day of systemic and topical analgesics usage
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.
Duration of other analgesics usage	0-7 days postoperatively	The duration in days of systemic and topical analgesics usage
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
Re-admission rate	30 days postoperatively	The rate of patients who were re-admitted due to refractory pain
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

Trial Locations

Locations (1)

Clinic of Colorectal and Minimally Invasive Surgery; 🇷🇺 Moscow, Russian Federation