NCT04361695

Preemptive Analgesia for Hemorrhoidectomy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Russian Society of Colorectal Surgeons · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemorrhoidectomy

Interventions

Type	Name	Description
PROCEDURE	Hemorrhoidectomy	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.
DRUG	Ketoprophenum	Ketoprophenum
DRUG	Placebo	Placebo

Timeline

• Start date: 2020-02-27
• Primary completion: 2021-02-25
• Completion: 2022-08-25
• First posted: 2020-04-24
• Last updated: 2020-04-24

Locations

1 site across 1 country: Russia