Preemptive Analgesia for Hemorrhoidectomy

Russian Society of Colorectal Surgeons

Status: Unknown

Conditions: Hemorrhoidectomy

Treatments: Drug: Placebo; Drug: Ketoprophenum; Procedure: Hemorrhoidectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04361695

10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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144 participants in 2 patient groups, including a placebo group

Ketoprophenum

Active Comparator group

Description:

A tablet with 10 mg Ketoprophenum is taken per os 2 hours before surgery

Treatment:

Procedure: Hemorrhoidectomy

Drug: Ketoprophenum

Placebo

Placebo Comparator group

Description:

A tablet containing starch is taken per os 2 hours before surgery

Treatment:

Procedure: Hemorrhoidectomy

Drug: Placebo