IntraopeRativE Use of periNeal Block for Hemorrhoidectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intraoperative Use of Perineal Block for Hemorrhoidectomy

Conditions
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Hemorrhoidectomy, Pudendal Nerve

Intervention / Treatment
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* Procedure: perineal block with usage of one of solutions
* Drug: epinephrine + ropivacaine +saline
* Drug: epinephrine + saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent. Patients over 18 years. Symptomatic grade III-IV hemorrhoids. Planned surgery: Milligan-Morgan hemorrhoidectomy. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: epinephrine + ropivacaine +saline<br>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<br>* 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.<br>Drug: epinephrine + ropivacaine +saline<br>* epinephrine + ropivacaine +saline<br>|
| Placebo Comparator: epinephrine + saline<br>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<br>* 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.<br>Drug: epinephrine + saline<br>* epinephrine + saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of opioid analgesics usage | The need to use opioid analgesics. | 1 day - 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 1 day - 1 week | 
| re-admission | The need for re-admission after operation | 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. | 1 day - 1 month | 
| The timing of returning to work. | The period between surgery and returning to normal work | 1 day - 1 month | 
| early postoperative complications | Assessment of early postoperative complications (bleeding, retention of urine, infectious complications). | 1 day - 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perineal block, hemorrhoidectomy, hemorrhoids, hemorrhoids treatment, pudendal nerve