IntraopeRativE Use of periNeal Block for Hemorrhoidectomy (IREN)

Intraoperative Use of Perineal Block for Hemorrhoidectomy

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.

Study Overview

• Status: Unknown
• Conditions: Hemorrhoidectomy; Pudendal Nerve
• Intervention / Treatment: Procedure: perineal block with usage of one of solutions; Drug: epinephrine + ropivacaine +saline; Drug: epinephrine + saline

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119435
    • Recruiting
    • Clinic of Colorectal and Minimally Invasive Surgery
    • Contact: Daniil Markaryan, PhD; Phone Number: +79035329245; Email: markaryan@kkmx.ru
    • Contact: Yuliia Churina, MD; Phone Number: +79154970361; Email: churina@kkmx.ru
    • Principal Investigator: Petr Tsarkov, Prof
    • Sub-Investigator: Bruno Roshe, Prof
    • Sub-Investigator: Daniil Markaryan, PhD
    • Sub-Investigator: Yuliia Churina, MD
    • Sub-Investigator: Yuliia Medkova, MD
    • Sub-Investigator: Inna Tulina, PhD
    • Sub-Investigator: Eduard Markaryan
    • Sub-Investigator: Mariana Dundua

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: perineal block with usage of one of solutions; 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.; Drug: epinephrine + ropivacaine +saline; epinephrine + ropivacaine +saline
Placebo Comparator: epinephrine + saline; 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; 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.; Drug: epinephrine + saline; epinephrine + saline

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Russian Society of Colorectal Surgeons

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2020
• Primary Completion (Anticipated): May 29, 2020
• Study Completion (Anticipated): May 30, 2020

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): May 29, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: hemorrhoidectomy; hemorrhoids; perineal block; hemorrhoids treatment; pudendal nerve
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Ropivacaine; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: 1 (Other Identifier: Mobile Health and Wellness Program)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No