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IntraopeRativE Use of periNeal Block for Hemorrhoidectomy

NCT04288349 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-05-29

No results posted yet for this study

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

Interventions

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

DRUG

epinephrine + saline

epinephrine + saline

Sponsors & Collaborators

  • Russian Society of Colorectal Surgeons

    lead OTHER

Principal Investigators

  • Petr Tsarkov, Prof · Russian Society of Colorectal Surgeons

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-20
Primary Completion
2020-05-29
Completion
2020-05-30

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04288349 on ClinicalTrials.gov