Clinical trial NCT04288349: IntraopeRativE Use of periNeal Block for Hemorrhoidectomy
Official title: Intraoperative Use of Perineal Block for Hemorrhoidectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemorrhoidectomy
Pudendal Nerve
Keywords: perineal block
hemorrhoidectomy
hemorrhoids
hemorrhoids treatment
pudendal nerve
Lead sponsor: Russian Society of Colorectal Surgeons
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: The rate of opioid analgesics usage
timeFrame: 1 day - 2 weeks
Secondary outcomes:
measure: systemic analgesics usage
timeFrame: 1 day - 2 weeks
measure: The duration of painless period after surgery
timeFrame: 1 day - 1 week
measure: re-admission
timeFrame: 1 day - 1 month
measure: quality of life with SF-36 questionnaire
timeFrame: 1 day - 1 month
measure: The timing of returning to work.
timeFrame: 1 day - 1 month
measure: early postoperative complications
timeFrame: 1 day - 1 month
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Clinic of Colorectal and Minimally Invasive Surgery
Study officials:
affiliation: Russian Society of Colorectal Surgeons
name: Petr Tsarkov, Prof
role: PRINCIPAL_INVESTIGATOR
References: