HemorrhoidectomyNCT04361695
Preemptive Analgesia for Hemorrhoidectomy
A study testing Hemorrhoidectomy and Ketoprophenum in people with Hemorrhoidectomy, run by Russian Society of Colorectal Surgeons at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemorrhoidectomy
- What is being tested?
- Hemorrhoidectomy and Ketoprophenum
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteRussia
- Study dates
- 27 Feb 2020to 25 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent.
- Patients over 18 years.
- Symptomatic grade III-IV haemorrhoids.
- Planned surgery: Milligan-Morgan hemorrhoidectomy
Who cannot join
- Patient's refusal to participate in the study.
- Pregnancy.
- Contraindication or technical inability to perform subarachnoid anaesthesia.
- Decompensated somatic diseases
Trial locations and contacts
1 site in 1 country.
Daniil Markaryan, PhD contact
Russia1 site, 1 recruiting
- Recruiting
Clinic of Colorectal and Minimally Invasive Surgery
Moscow, 119435
Tatiana Garmanova, PhD, +79773429249, garmanova@kkmx.ru
Daniil Markaryan, PhD, markaryan@kkmx.ru
About this study
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.
Read the 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
- Being tested
- Hemorrhoidectomy, Ketoprophenum, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemorrhoidectomyProcedure or surgery
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.
KetoprophenumDrug
Ketoprophenum
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Ketoprophenum | Active comparator | A tablet with 10 mg Ketoprophenum is taken per os 2 hours before surgery Receives: Procedure: Hemorrhoidectomy; Drug: Ketoprophenum |
| Placebo | Placebo comparator | A tablet containing starch is taken per os 2 hours before surgery Receives: Procedure: Hemorrhoidectomy; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of opioid analgesics usage
The frequency of opioid administration per day
Measured: 0-7 days postoperatively
Secondary outcomes (7)
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.
Measured: 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
Measured: 0-7 days postoperatively
Frequency of other analgesics usage
Times per day of systemic and topical analgesics usage
Measured: 0-7 days postoperatively
Re-admission rate
The rate of patients who were re-admitted due to refractory pain
Measured: 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
Measured: 7th and 30th days postoperatively
Returning to work
The period of time in days from the operation to returning to work
Measured: 30 days postoperatively
The rate of early postoperative complications
The rate of complications: bleeding, retention of urine, infectious complications in early postoperative period
Measured: 0-30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start27 Feb 2020
- Primary completion25 Feb 2021 (estimated)
- Study completion25 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Society of Colorectal Surgeons
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petr Tsarkov, Professor, Principal investigator, Russian Society of Colorectal Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361695
- Sponsor's protocol ID
- 10
- Status last verified
- Apr 2020
- First submitted
- 26 Mar 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35761383
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Analgesia for Hemorrhoidectomy
- ClinicalTrials.gov ID
- NCT04361695
- Acronym / sponsor ID
- 10
- Conditions
- Hemorrhoidectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Russian Society of Colorectal SurgeonsUniversity, hospital or other
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 25 Feb 2021 (estimated)
- Study completion
- 25 Aug 2022 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketoprophenum | Active comparator | Procedure: Hemorrhoidectomy, Drug: KetoprophenumA tablet with 10 mg Ketoprophenum is taken per os 2 hours before surgery |
| Placebo | Placebo comparator | Procedure: Hemorrhoidectomy, Drug: PlaceboA tablet containing starch is taken per os 2 hours before surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent.
- Patients over 18 years.
- Symptomatic grade III-IV haemorrhoids.
- Planned surgery: Milligan-Morgan hemorrhoidectomy
Key exclusion criteria (4 listed)
- Patient's refusal to participate in the study.
- Pregnancy.
- Contraindication or technical inability to perform subarachnoid anaesthesia.
- Decompensated somatic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemorrhoidectomyThe 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. | Procedure or surgery | Ketoprophenum, Placebo |
| KetoprophenumKetoprophenum | Drug | Ketoprophenum |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
The frequency of opioid analgesics usage
Time frame: 0-7 days postoperatively
The frequency of opioid administration per day
7 secondary outcomes
Severity of pain
Time frame: 6, 12 and 24 hours after the operation, then 2 times per day up to 7th postoperative day
Duration of other analgesics usage
Time frame: 0-7 days postoperatively
Frequency of other analgesics usage
Time frame: 0-7 days postoperatively
Re-admission rate
Time frame: 30 days postoperatively
Overall quality of life
Time frame: 7th and 30th days postoperatively
Returning to work
Time frame: 30 days postoperatively
The rate of early postoperative complications
Time frame: 0-30 days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Derived from this study: PubMed 35761383Kazachenko 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniil Markaryan, PhD contact
Petr Tsarkov, Professor principal investigator
Russian Society of Colorectal Surgeons
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemorrhoidectomy and Ketoprophenum in people with Hemorrhoidectomy, run by Russian Society of Colorectal Surgeons at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tatiana Garmanova, PhD (+79773429249, garmanova@kkmx.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of opioid analgesics usage (time frame: 0-7 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04361695, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.