HemorrhoidectomyIRENNCT04288349
IntraopeRativE Use of periNeal Block for Hemorrhoidectomy
A study testing perineal block with usage of one of solutions, epinephrine + ropivacaine +saline and epinephrine + saline in people with Hemorrhoidectomy and Pudendal Nerve, run by Russian Society of Colorectal Surgeons at 1 site in Russia.
Trial summary
Perineal block with the anesthesia of the pudendal nerve's terminal branches allows to perform a hemorrhoidectomy with the optimal intraoperative and postoperative analgesia The purpose of this study is to assess the effectiveness of the intraoperative use of perineal block with spinal anesthesia to reduce… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemorrhoidectomy, Pudendal Nerve
- What is being tested?
- perineal block with usage of one of solutions, epinephrine + ropivacaine +saline and epinephrine + saline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 20 Feb 2020to 30 May 2020
- 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 hemorrhoids.
- Planned surgery: Milligan-Morgan hemorrhoidectomy.
Who cannot join
- Patient's refuse to participate in the study.
- Pregnancy.
- Сontraindications or technical inability to perform subarachnoid anesthesia.
- Decompensated somatic diseases.
- Inflammation of the perianal region.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Clinic of Colorectal and Minimally Invasive Surgery
Moscow, 119435
Yuliia Churina, MD, +79154970361, churina@kkmx.ru
Daniil Markaryan, PhD, +79035329245, markaryan@kkmx.ru
About this study
Official title: Intraoperative Use of Perineal Block for Hemorrhoidectomy
Perineal block with the anesthesia of the pudendal nerve's terminal branches allows to perform a hemorrhoidectomy with the optimal intraoperative and postoperative analgesia The purpose of this study is to assess the effectiveness of the intraoperative use of perineal block with spinal anesthesia to reduce postoperative pain and the amount of used analgesics.
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.
Traditionally spinal or general anesthesia is used in proctological practice. However, the number of studies about using of perianal local anesthesia, both in combination with general anesthesia and as a separate practice has been increasing recently.
Perineal block with the anesthesia of the pudendal nerve's terminal branches allows to perform a hemorrhoidectomy with the optimal intraoperative and postoperative analgesia. The drugs used for this have some pharmacological differences in the duration of the drug and the form of administration.
The aim of this prospective, randomized, double-blind study is to assess the effectiveness of the intraoperative use of perineal block with spinal anesthesia to reduce postoperative pain and the amount of used analgesics.
- Conditions
- Hemorrhoidectomy, Pudendal Nerve
- Being tested
- perineal block with usage of one of solutions, epinephrine + ropivacaine +saline, epinephrine + saline
- Keywords
- perineal block, hemorrhoidectomy, hemorrhoids, hemorrhoids treatment, pudendal nerve
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perineal block with usage of one of solutionsProcedure or surgery
Perineal block using solution of ropivocaine and epinephrine for the first group was performed. Anococcygeal ligament is infiltrated with 10 ml of the solution after the intracutaneous infiltration in 2 cm from the anus. Ten ml of the solution is injected in ischiorectal fat on each side. The needle is orienteered at the angle of 45 degrees cranially and laterally, and to the surface what allows the surgeon to anesthetize the deep branches of the pudendal nerve. In addition, 10 ml of solution is injected transdermal on the front edge of the anus with further subcutaneous infiltration on each side of the anus to provide anesthesia to the nerve branches laying more superficial. The total amount of the injected solution is 50 ml.
epinephrine + ropivacaine +salineDrug
epinephrine + ropivacaine +saline
epinephrine + salineDrug
epinephrine + saline
| Study group | Role | What they receive |
|---|---|---|
| epinephrine + ropivacaine +saline | Active comparator | 1% epinephrine solution + 30 ml of 1% ropivacaine solution diluted with 20 ml of 0.9% saline for achievement a 0.75% anesthetic solution in a ratio of 1: 200 000 Receives: Procedure: perineal block with usage of one of solutions; Drug: epinephrine + ropivacaine +saline |
| epinephrine + saline | Placebo comparator | 1% epinephrine solution + 50 ml of 0.9% saline in a ratio of 1: 200 000. Receives: Procedure: perineal block with usage of one of solutions; Drug: epinephrine + saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of opioid analgesics usage
The need to use opioid analgesics.
Measured: 1 day - 2 weeks
Secondary outcomes (6)
systemic analgesics usage
The duration and frequency of systemic analgesics usage, including opioid and topical local anesthetics in early postoperative period. The assessment of the required amount and frequency of NSAIDs (nonsteroidal anti-inflammatory drugs) usage in the first 24 hours, then - daily up to 7 days
Measured: 1 day - 2 weeks
The duration of painless period after surgery
the time from the moment of the blockade to the need of intake the first dose of analgesics.
Measured: 1 day - 1 week
re-admission
The need for re-admission after operation
Measured: 1 day - 1 month
quality of life with SF-36 questionnaire
The assessment of quality of life after surgery using the SF-36 questionnaire (The Short Form-36). Scale evaluates physical and mental status after operation.
Measured: 1 day - 1 month
The timing of returning to work.
The period between surgery and returning to normal work
Measured: 1 day - 1 month
early postoperative complications
Assessment of early postoperative complications (bleeding, retention of urine, infectious complications).
Measured: 1 day - 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start20 Feb 2020
- Primary completion29 May 2020 (estimated)
- Study completion30 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Society of Colorectal Surgeons
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petr Tsarkov, Prof, Principal investigator, Russian Society of Colorectal Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288349
- Sponsor's protocol ID
- 1
- Acronym
- IREN
- Status last verified
- May 2020
- First submitted
- 26 Feb 2020
- Last updated
- 29 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Use of Perineal Block for Hemorrhoidectomy
- ClinicalTrials.gov ID
- NCT04288349
- Acronym / sponsor ID
- IREN / 1
- Conditions
- Hemorrhoidectomy, Pudendal Nerve
- Keywords
- perineal block, hemorrhoidectomy, hemorrhoids, hemorrhoids treatment, pudendal nerve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Russian Society of Colorectal SurgeonsUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 29 May 2020 (estimated)
- Study completion
- 30 May 2020 (estimated)
- First posted
- 28 Feb 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.
Perineal block with the anesthesia of the pudendal nerve's terminal branches allows to perform a hemorrhoidectomy with the optimal intraoperative and postoperative analgesia The purpose of this study is to assess the effectiveness of the intraoperative use of perineal block with spinal anesthesia to reduce postoperative pain and the amount of used analgesics.
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.
Traditionally spinal or general anesthesia is used in proctological practice. However, the number of studies about using of perianal local anesthesia, both in combination with general anesthesia and as a separate practice has been increasing recently.
Perineal block with the anesthesia of the pudendal nerve's terminal branches allows to perform a hemorrhoidectomy with the optimal intraoperative and postoperative analgesia. The drugs used for this have some pharmacological differences in the duration of the drug and the form of administration.
The aim of this prospective, randomized, double-blind study is to assess the effectiveness of the intraoperative use of perineal block with spinal anesthesia to reduce 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 |
|---|---|---|
| epinephrine + ropivacaine +saline | Active comparator | Procedure: perineal block with usage of one of solutions, Drug: epinephrine + ropivacaine +saline1% epinephrine solution + 30 ml of 1% ropivacaine solution diluted with 20 ml of 0.9% saline for achievement a 0.75% anesthetic solution in a ratio of 1: 200 000 |
| epinephrine + saline | Placebo comparator | Procedure: perineal block with usage of one of solutions, Drug: epinephrine + saline1% epinephrine solution + 50 ml of 0.9% saline in a ratio of 1: 200 000. |
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 hemorrhoids.
- Planned surgery: Milligan-Morgan hemorrhoidectomy.
Key exclusion criteria (5 listed)
- Patient's refuse to participate in the study.
- Pregnancy.
- Сontraindications or technical inability to perform subarachnoid anesthesia.
- Decompensated somatic diseases.
- Inflammation of the perianal region.
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 |
|---|---|---|
| perineal block with usage of one of solutionsPerineal block using solution of ropivocaine and epinephrine for the first group was performed. Anococcygeal ligament is infiltrated with 10 ml of the solution after the intracutaneous infiltration in 2 cm from the anus. Ten ml of the solution is injected in ischiorectal fat on each side. The needle is orienteered at the angle of 45 degrees cranially and laterally, and to the surface what allows the surgeon to anesthetize the deep branches of the pudendal nerve. In addition, 10 ml of solution is injected transdermal on the front edge of the anus with further subcutaneous infiltration on each side of the anus to provide anesthesia to the nerve branches laying more superficial. The total amount of the injected solution is 50 ml. | Procedure or surgery | epinephrine + ropivacaine +saline, epinephrine + saline |
| epinephrine + ropivacaine +salineepinephrine + ropivacaine +saline | Drug | epinephrine + ropivacaine +saline |
| epinephrine + salineepinephrine + saline | Drug | epinephrine + saline |
Primary outcome
The rate of opioid analgesics usage
Time frame: 1 day - 2 weeks
The need to use opioid analgesics.
6 secondary outcomes
systemic analgesics usage
Time frame: 1 day - 2 weeks
The duration of painless period after surgery
Time frame: 1 day - 1 week
re-admission
Time frame: 1 day - 1 month
quality of life with SF-36 questionnaire
Time frame: 1 day - 1 month
The timing of returning to work.
Time frame: 1 day - 1 month
early postoperative complications
Time frame: 1 day - 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
Related trials for Hemorrhoidectomy
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Ligasure Versus Conventional Diathermy in Hemorrhoidectomy
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The Use of Electronic Bidets Compared to Water Rinsing After Surgery for Anal Fistula or Haemorrhoidal Disease: a Pilot Study
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Laser Hemorrhoidoplasty Versus Open Hemorrhoidectomy for Postoperative Pain
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Not yet recruitingPhase 2
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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.
Petr Tsarkov, Prof 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 perineal block with usage of one of solutions, epinephrine + ropivacaine +saline and epinephrine + saline in people with Hemorrhoidectomy and Pudendal Nerve, 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 5 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 29 May 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 Yuliia Churina (+79154970361, churina@kkmx.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of opioid analgesics usage (time frame: 1 day - 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2020.