Preemptive Analgesia for Hemorrhoidectomy

Hemorrhoidectomy Clinical Trial

Official title:

Preemptive Analgesia for Hemorrhoidectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04361695
• Other study ID #: 10
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2020
• Est. completion date: August 25, 2022

Study information

• Verified date: April 2020
• Source: Russian Society of Colorectal Surgeons
• Contact: Tatiana Garmanova, PhD
• Phone: +79773429249
• Email: garmanova[@]kkmx.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: August 25, 2022
• Est. primary completion date: February 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhoidectomy

Intervention

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
• Placebo
Placebo

Locations

Country	Name	City	State
Russian Federation	Clinic of Colorectal and Minimally Invasive Surgery	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Russian Society of Colorectal Surgeons

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequency of opioid analgesics usage	The frequency of opioid administration per day	0-7 days postoperatively
Secondary	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
Secondary	Duration of other analgesics usage	The duration in days of systemic and topical analgesics usage	0-7 days postoperatively
Secondary	Frequency of other analgesics usage	Times per day of systemic and topical analgesics usage	0-7 days postoperatively
Secondary	Re-admission rate	The rate of patients who were re-admitted due to refractory pain	30 days postoperatively
Secondary	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
Secondary	Returning to work	The period of time in days from the operation to returning to work	30 days postoperatively
Secondary	The rate of early postoperative complications	The rate of complications: bleeding, retention of urine, infectious complications in early postoperative period	0-30 days postoperatively