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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| epinephrine + saline | Placebo Comparator | 1% epinephrine solution + 50 ml of 0.9% saline in a ratio of 1: 200 000. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| perineal block with usage of one of solutions | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of opioid analgesics usage | The need to use opioid analgesics. | 1 day - 2 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuliia Churina | Contact | +79154970361 | churina@kkmx.ru | |
| Daniil Markaryan, PhD | Contact | +79035329245 | markaryan@kkmx.ru |
| Name | Affiliation | Role |
|---|---|---|
| Petr Tsarkov, Prof | Russian Society of Colorectal Surgeons | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic of Colorectal and Minimally Invasive Surgery | Recruiting | Moscow | 119435 | Russia |
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| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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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.
|
| epinephrine + ropivacaine +saline | Drug | epinephrine + ropivacaine +saline |
|
| epinephrine + saline | Drug | epinephrine + saline |
|
| 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |