IntraopeRativE Use of periNeal Block for Hemorrhoidectomy

Not Applicable

• Conditions: Hemorrhoidectomy; Pudendal Nerve
• Interventions: Procedure: perineal block with usage of one of solutions; Drug: epinephrine + saline; Drug: epinephrine + ropivacaine +saline

• Registration Number: NCT04288349
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2020-02-20
• Study First Submitted: 2020-02-26
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-02-28
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-27
• Primary Completion: 2020-05-29
• Last Update Posted: 2020-05-29
• Study Completion: 2020-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
epinephrine + saline	epinephrine + saline	1% epinephrine solution + 50 ml of 0.9% saline in a ratio of 1: 200 000.
epinephrine + ropivacaine +saline	perineal block with usage of one of solutions	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 + ropivacaine +saline	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
epinephrine + saline	perineal block with usage of one of solutions	1% epinephrine solution + 50 ml of 0.9% saline in a ratio of 1: 200 000.

Primary Outcome Measures

Name	Time	Method
The rate of opioid analgesics usage	1 day - 2 weeks	The need to use opioid analgesics.

Secondary Outcome Measures

Name	Time	Method
systemic analgesics usage	1 day - 2 weeks	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
re-admission	1 day - 1 month	The need for re-admission after operation
The duration of painless period after surgery	1 day - 1 week	the time from the moment of the blockade to the need of intake the first dose of analgesics.
quality of life with SF-36 questionnaire	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.
The timing of returning to work.	1 day - 1 month	The period between surgery and returning to normal work
early postoperative complications	1 day - 1 month	Assessment of early postoperative complications (bleeding, retention of urine, infectious complications).

Trial Locations

Locations (1)

Clinic of Colorectal and Minimally Invasive Surgery; 🇷🇺 Moscow, Russian Federation