Preemptive Analgesia for Hemorrhoidectomy

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.

Study Overview

• Status: Unknown
• Conditions: Hemorrhoidectomy
• Intervention / Treatment: Drug: Placebo; Procedure: Hemorrhoidectomy; Drug: Ketoprophenum

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 Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tatiana Garmanova, PhD; Phone Number: +79773429249; Email: garmanova@kkmx.ru
• Study Contact Backup: Name: Daniil Markaryan, PhD; Email: makaryan@kkmx.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119435
    • Recruiting
    • Clinic of Colorectal and Minimally Invasive Surgery
    • Contact: Tatiana Garmanova, PhD; Phone Number: +79773429249; Email: garmanova@kkmx.ru
    • Contact: Daniil Markaryan, PhD; Email: markaryan@kkmx.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ketoprophenum; A tablet with 10 mg Ketoprophenum is taken per os 2 hours before surgery	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 Comparator: Placebo; A tablet containing starch is taken per os 2 hours before surgery	Drug: Placebo; Placebo; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Russian Society of Colorectal Surgeons
• Investigators: Principal Investigator: Petr Tsarkov, Professor, Russian Society of Colorectal Surgeons

Publications and helpful links

General Publications

• Kazachenko E, Garmanova T, Derinov A, Markaryan D, Lee H, Magbulova S, Tsarkov P. Preemptive analgesia for hemorrhoidectomy: study protocol for a prospective, randomized, double-blind trial. Trials. 2022 Jun 27;23(1):536. doi: 10.1186/s13063-022-06107-0.

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2020
• Primary Completion (Anticipated): February 25, 2021
• Study Completion (Anticipated): August 25, 2022

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: April 23, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 23, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No