IntraopeRativE Use of periNeal Block for Hemorrhoidectomy
NCT ID: NCT04288349
Last Updated: 2020-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2020-02-20
2020-05-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
The probability of introduction to each group is 50%. The number of patients in both groups equally and is 50 people.
Study Groups
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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
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.
epinephrine + ropivacaine +saline
epinephrine + ropivacaine +saline
epinephrine + saline
1% epinephrine solution + 50 ml of 0.9% saline in a ratio of 1: 200 000.
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.
epinephrine + saline
epinephrine + saline
Interventions
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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.
epinephrine + ropivacaine +saline
epinephrine + ropivacaine +saline
epinephrine + saline
epinephrine + saline
Eligibility Criteria
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Inclusion Criteria
2. Patients over 18 years.
3. Symptomatic grade III-IV hemorrhoids.
4. Planned surgery: Milligan-Morgan hemorrhoidectomy.
Exclusion Criteria
2. Pregnancy.
3. Сontraindications or technical inability to perform subarachnoid anesthesia.
4. Decompensated somatic diseases.
5. Inflammation of the perianal region.
18 Years
75 Years
ALL
No
Sponsors
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Russian Society of Colorectal Surgeons
OTHER
Responsible Party
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Principal Investigators
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Petr Tsarkov, Prof
Role: PRINCIPAL_INVESTIGATOR
Russian Society of Colorectal Surgeons
Locations
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Clinic of Colorectal and Minimally Invasive Surgery
Moscow, , Russia
Countries
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Central Contacts
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Facility Contacts
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Yuliia Churina, MD
Role: primary
Daniil Markaryan, PhD
Role: backup
Other Identifiers
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1
Identifier Type: -
Identifier Source: org_study_id