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Completed

NCT Number: NCT04251884

Pudendal Nerve Block for Hemorrhoidectomy

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

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Key information

Conditions

Hemorrhoids Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Rectal Diseases Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Regionale di Bellinzona e Valli

Bellinzona, 6500, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Local anesthetic (ropivacaine)

Procedure

Patients randomized in the treatment arm will receive a sonography-guided pudendal nerve block

Other names: No pudendal nerve block

Primary outcomes

  1. 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"

Secondary outcomes

  1. 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"

  2. Opioids Consumption

    Time frame: Within 48 hours

  3. Lenght of Hospital Stay

    Time frame: up to 2 weeks

  4. Complications Related to the Pudendal Nerve Block

    Time frame: Within 6 weeks

  5. Direct and Indirect Cost Analysis in Out- and In-patients

    Time frame: Within the hospital stay

    Ongoing

Sponsors and collaborators

Lead sponsor

Francesco Mongelli

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Feb 5, 2020
Registry last updated
Mar 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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