Pudendal Nerve Block for Hemorrhoidectomy

March 1, 2022 updated by: Francesco Mongelli

Pudendal Nerve Block in Patient Treated for Hemorrhoidectomy Under Spinal Anaesthesia: Prospective Randomized Double-blind Controlled Trial

Patients undergoing Milligan-Morgan hemorrhoidectomy will be randomized to receive or not the pudendal nerve block after the spinal anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients included were those undergoing Milligan-Morgan hemorrhoidectomy under spinal anaesthesia from January 2018 to December 2019. Exclusion criteria were age < 18 years old, pregnancy and allergy to local anaesthetics. Patients meeting inclusion and exclusion criteria were randomized to undergo an ultrasound-guided pudendal nerve block. Per-protocol all patients received postoperative metronidazole 500 mg for 3 days, laxative, a basis analgesia with NSAID and opioids as needed. Postoperative pain on the visual analogue scale (VAS) at 6, 12, 24 and 48 hours, opioids needed, complications and length of hospital stay were recorded. Patients and ward personnel were not informed about the treatment arm. All Patients were further controlled 6 weeks after the intervention.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bellinzona, Switzerland, 6500
        • Ospedale Regionale di Bellinzona e Valli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patients affected by haemorrhoids (grade III and IV) and treated with Milligan-Morgan hemorrhoidectomy under spinal anaesthesia
  • Signed informed consent

Exclusion criteria:

  • Age < 18 years old
  • Pregnancy
  • Allergy to local anaesthetics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Receiving the pudendal nerve block
Procedure: Local anesthetic (ropivacaine)
Patients randomized in the treatment arm will receive a sonography-guided pudendal nerve block
Other Names:
  • No pudendal nerve block
Active Comparator: Not receiving the pudendal nerve block
Procedure: Local anesthetic (ropivacaine)
Patients randomized in the treatment arm will receive a sonography-guided pudendal nerve block
Other Names:
  • No pudendal nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain on the Visual Analogue Scale (VAS)
Time Frame: at 24 hours after the hemorrhoidectomy
Visual analogue scale (VAS) ranges from 0 to 10, where 0 is "no pain at all" and 10 is "the strongest pain"
at 24 hours after the hemorrhoidectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain on the Visual Analogue Scale (VAS)
Time Frame: at 6, 12 and 48 hours after the operation
Visual analogue scale (VAS) ranges from 0 to 10, where 0 is "no pain at all" and 10 is "the strongest pain"
at 6, 12 and 48 hours after the operation
Opioids Consumption
Time Frame: Within 48 hours
Within 48 hours
Lenght of Hospital Stay
Time Frame: up to 2 weeks
up to 2 weeks
Complications Related to the Pudendal Nerve Block
Time Frame: Within 6 weeks
Within 6 weeks
Direct and Indirect Cost Analysis in Out- and In-patients
Time Frame: Within the hospital stay
Ongoing
Within the hospital stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Francesco Mongelli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

December 29, 2019

Study Completion (Actual)

January 30, 2020

Study Registration Dates

First Submitted

January 30, 2020

First Submitted That Met QC Criteria

January 30, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

March 11, 2022

Last Update Submitted That Met QC Criteria

March 1, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE TI 3222

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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