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IntraopeRativE Use of periNeal Block for Hemorrhoidectomy (IREN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04288349
Recruitment Status : Recruiting
First Posted : February 28, 2020
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Russian Society of Colorectal Surgeons

Brief 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 postoperative pain and the amount of used analgesics.

Condition or disease Intervention/treatment Phase
Hemorrhoidectomy Pudendal Nerve Procedure: perineal block with usage of one of solutions Drug: epinephrine + ropivacaine +saline Drug: epinephrine + saline Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:

Randomization of the patients included in the study was performed before surgery. Patients were being randomly divided into two groups. All patients getting subarachnoid anesthesia. Perineal block using solution of ropivocaine and epinephrine for the first group was performed and placebo with epinephrine - for the second group. A researcher who does not participate in the surgery and does not contact with patients at all perioperative stages performs randomization and prepares a solution block. Neither the patient nor the operating surgeon and the doctors who register the results of the treatment are not informed about the anesthesia used in each case.

The probability of introduction to each group is 50%. The number of patients in both groups equally and is 50 people.

Primary Purpose: Treatment
Official Title: Intraoperative Use of Perineal Block for Hemorrhoidectomy
Actual Study Start Date : February 20, 2020
Estimated Primary Completion Date : April 29, 2020
Estimated Study Completion Date : April 30, 2020


Arm Intervention/treatment
Active Comparator: epinephrine + ropivacaine +saline
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
Procedure: perineal block with usage of one of solutions
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.

Drug: epinephrine + ropivacaine +saline
epinephrine + ropivacaine +saline

Placebo Comparator: epinephrine + saline
1% epinephrine solution + 50 ml of 0.9% saline in a ratio of 1: 200 000.
Procedure: perineal block with usage of one of solutions
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.

Drug: epinephrine + saline
epinephrine + saline




Primary Outcome Measures :
  1. The duration of painless period after surgery [ Time Frame: 1 day - 1 week ]
    the time from the moment of the blockade to the need of intake the first dose of analgesics.


Secondary Outcome Measures :
  1. systemic analgesics usage [ Time Frame: 1 day - 1 week ]
    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

  2. opioid analgesics usage [ Time Frame: 1 day - 1 week ]
    The need to use opioid analgesics.

  3. re-admission [ Time Frame: 1 day - 1 month ]
    The need for re-admission after operation

  4. quality of life with SF-36 questionnaire [ Time Frame: 1 day - 1 month ]
    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.

  5. The timing of returning to work. [ Time Frame: 1 day - 1 month ]
  6. early postoperative complications [ Time Frame: 1 day - 1 month ]
    Assessment of early postoperative complications (bleeding, retention of urine, infectious complications).



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent.
  2. Patients over 18 years.
  3. Symptomatic grade III-IV hemorrhoids.
  4. Planned surgery: Milligan-Morgan hemorrhoidectomy.

Exclusion Criteria:

  1. Patient`s refuse to participate in the study.
  2. Pregnancy.
  3. Сontraindications or technical inability to perform subarachnoid anesthesia.
  4. Decompensated somatic diseases.
  5. Inflammation of the perianal region.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04288349


Contacts
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Contact: Yuliia Churina +79154970361 churina.1238@mail.ru
Contact: Daniil Markaryan, PhD +79035329245 dmarkaryan@gmail.com

Locations
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Russian Federation
Clinic of Colorectal and Minimally Invasive Surgery Recruiting
Moscow, Russian Federation, 119435
Contact: Yuliia Churina, MD    +79154970361    churina.1238@mail.ru   
Contact: Daniil Markaryan, PhD    +79035329245    dmarkaryan@gmail.com   
Principal Investigator: Petr Tsarkov, Prof         
Sub-Investigator: Bruno Roshe, Prof         
Sub-Investigator: Daniil Markaryan, PhD         
Sub-Investigator: Yuliia Churina, MD         
Sub-Investigator: Yuliia Medkova, MD         
Sub-Investigator: Inna Tulina, PhD         
Sub-Investigator: Eduard Markaryan         
Sub-Investigator: Mariana Dundua         
Sponsors and Collaborators
Russian Society of Colorectal Surgeons
Investigators
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Principal Investigator: Petr Tsarkov, Prof Russian Society of Colorectal Surgeons

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Responsible Party: Russian Society of Colorectal Surgeons
ClinicalTrials.gov Identifier: NCT04288349    
Other Study ID Numbers: 1
First Posted: February 28, 2020    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Russian Society of Colorectal Surgeons:
perineal block
hemorrhoidectomy
hemorrhoids
hemorrhoids treatment
pudendal nerve
Additional relevant MeSH terms:
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Epinephrine
Racepinephrine
Ropivacaine
Pharmaceutical Solutions
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents