IntraopeRativE Use of periNeal Block for Hemorrhoidectomy (IREN)

Russian Society of Colorectal Surgeons

Status: Unknown

Conditions: Pudendal Nerve; Hemorrhoidectomy

Treatments: Procedure: perineal block with usage of one of solutions; Drug: epinephrine + saline; Drug: epinephrine + ropivacaine +saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04288349

1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

epinephrine + ropivacaine +saline

Active Comparator group

Description:

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

Treatment:

Drug: epinephrine + ropivacaine +saline

Procedure: perineal block with usage of one of solutions

epinephrine + saline

Placebo Comparator group

Description:

1% epinephrine solution + 50 ml of 0.9% saline in a ratio of 1: 200 000.

Treatment:

Drug: epinephrine + saline

Procedure: perineal block with usage of one of solutions