IntraopeRativE Use of periNeal Block for Hemorrhoidectomy

NCT04288349 | Unknown

• 1 other identifier: 1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhoidectomy; Pudendal Nerve

Keywords

perineal block; hemorrhoidectomy; hemorrhoids; hemorrhoids treatment; pudendal nerve

Outcome Measures

Primary Outcomes (1)

• The rate of opioid analgesics usage

  The need to use opioid analgesics.

  1 day - 2 weeks

Secondary Outcomes (6)

• systemic analgesics usage

  1 day - 2 weeks

• The duration of painless period after surgery

  1 day - 1 week

• re-admission

  1 day - 1 month

• quality of life with SF-36 questionnaire

  1 day - 1 month

• The timing of returning to work.

  1 day - 1 month

Study Arms (2)

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

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

epinephrine + saline

PLACEBO COMPARATOR

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; Drug: epinephrine + saline

Interventions

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.

epinephrine + ropivacaine +saline; epinephrine + saline

epinephrine + ropivacaine +saline DRUG

epinephrine + ropivacaine +saline

epinephrine + ropivacaine +saline

epinephrine + saline DRUG

epinephrine + saline

epinephrine + saline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Patients over 18 years.
• Symptomatic grade III-IV hemorrhoids.
• Planned surgery: Milligan-Morgan hemorrhoidectomy.

You may not qualify if:

• Patient's refuse to participate in the study.
• Pregnancy.
• Сontraindications or technical inability to perform subarachnoid anesthesia.
• Decompensated somatic diseases.
• Inflammation of the perianal region.

Sponsors & Collaborators

• Russian Society of Colorectal Surgeons: lead

Study Sites (1)

Clinic of Colorectal and Minimally Invasive Surgery

Moscow, 119435, Russia

RECRUITING

MeSH Terms

Conditions

Hemorrhoids

Interventions

Epinephrine; Sodium Chloride

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Petr Tsarkov, Prof

  Russian Society of Colorectal Surgeons

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuliia Churina

CONTACT

+79154970361; churina@kkmx.ru

Daniil Markaryan, PhD

CONTACT

+79035329245; markaryan@kkmx.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: February 28, 2020
• Study Start: February 20, 2020
• Primary Completion: May 29, 2020
• Study Completion: May 30, 2020
• Last Updated: May 29, 2020

Record last verified: 2020-05

Locations

RU (1)