Clinical trial NCT04361695: Preemptive Analgesia for Hemorrhoidectomy
Official title: Preemptive Analgesia for Hemorrhoidectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemorrhoidectomy
Lead sponsor: Russian Society of Colorectal Surgeons
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The frequency of opioid analgesics usage
timeFrame: 0-7 days postoperatively
Secondary outcomes:
measure: Severity of pain
timeFrame: 6, 12 and 24 hours after the operation, then 2 times per day up to 7th postoperative day
measure: Duration of other analgesics usage
timeFrame: 0-7 days postoperatively
measure: Frequency of other analgesics usage
timeFrame: 0-7 days postoperatively
measure: Re-admission rate
timeFrame: 30 days postoperatively
measure: Overall quality of life
timeFrame: 7th and 30th days postoperatively
measure: Returning to work
timeFrame: 30 days postoperatively
measure: The rate of early postoperative complications
timeFrame: 0-30 days postoperatively
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Clinic of Colorectal and Minimally Invasive Surgery
Study officials:
affiliation: Russian Society of Colorectal Surgeons
name: Petr Tsarkov, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.