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Pudendal Nerve Block for Hemorrhoidectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251884
Recruitment Status : Completed
First Posted : February 5, 2020
Results First Posted : June 5, 2020
Last Update Posted : March 11, 2022
Sponsor:
Information provided by (Responsible Party):
Francesco Mongelli, Ospedale Regionale Bellinzona e Valli

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

Condition or disease Intervention/treatment Phase
Hemorrhoids Postoperative Pain Procedure: Local anesthetic (ropivacaine) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pudendal Nerve Block in Patient Treated for Hemorrhoidectomy Under Spinal Anaesthesia: Prospective Randomized Double-blind Controlled Trial
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : December 29, 2019
Actual Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Arms and Interventions
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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 Name: 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 Name: No pudendal nerve block


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251884


Locations
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Switzerland
Ospedale Regionale di Bellinzona e Valli
Bellinzona, Switzerland, 6500
Sponsors and Collaborators
Francesco Mongelli
  Study Documents (Full-Text)

Documents provided by Francesco Mongelli, Ospedale Regionale Bellinzona e Valli:
Study Protocol and Statistical Analysis Plan  [PDF] October 8, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Francesco Mongelli, MD, Ospedale Regionale Bellinzona e Valli
ClinicalTrials.gov Identifier: NCT04251884    
Other Study ID Numbers: CE TI 3222
First Posted: February 5, 2020    Key Record Dates
Results First Posted: June 5, 2020
Last Update Posted: March 11, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
 Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents