Preemptive Analgesia for Hemorrhoidectomy
1 other identifier
interventional
144
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 27, 2020
CompletedFirst Submitted
Initial submission to the registry
March 26, 2020
CompletedFirst Posted
Study publicly available on registry
April 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2022
CompletedApril 24, 2020
April 1, 2020
12 months
March 26, 2020
April 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
The frequency of opioid analgesics usage
The frequency of opioid administration per day
0-7 days postoperatively
Secondary Outcomes (7)
Severity of pain
6, 12 and 24 hours after the operation, then 2 times per day up to 7th postoperative day
Duration of other analgesics usage
0-7 days postoperatively
Frequency of other analgesics usage
0-7 days postoperatively
Re-admission rate
30 days postoperatively
Overall quality of life
7th and 30th days postoperatively
- +2 more secondary outcomes
Study Arms (2)
Ketoprophenum
ACTIVE COMPARATORA tablet with 10 mg Ketoprophenum is taken per os 2 hours before surgery
Placebo
PLACEBO COMPARATORA tablet containing starch is taken per os 2 hours before surgery
Interventions
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.
Eligibility Criteria
You may qualify if:
- Written informed consent.
- Patients over 18 years.
- Symptomatic grade III-IV haemorrhoids.
- Planned surgery: Milligan-Morgan hemorrhoidectomy
You may not qualify if:
- Patient's refusal to participate in the study.
- Pregnancy.
- Contraindication or technical inability to perform subarachnoid anaesthesia.
- Decompensated somatic diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinic of Colorectal and Minimally Invasive Surgery
Moscow, 119435, Russia
Related Publications (1)
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.
PMID: 35761383DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Petr Tsarkov, Professor
Russian Society of Colorectal Surgeons
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2020
First Posted
April 24, 2020
Study Start
February 27, 2020
Primary Completion
February 25, 2021
Study Completion
August 25, 2022
Last Updated
April 24, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share