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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04251884
Other study ID # CE TI 3222
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date January 30, 2020

Study information

Verified date March 2022
Source Ospedale Regionale Bellinzona e Valli
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date January 30, 2020
Est. primary completion date December 29, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Local anesthetic (ropivacaine)
Patients randomized in the treatment arm will receive a sonography-guided pudendal nerve block

Locations

Country Name City State
Switzerland Ospedale Regionale di Bellinzona e Valli Bellinzona

Sponsors (1)

Lead Sponsor Collaborator
Francesco Mongelli

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative Pain on the Visual Analogue Scale (VAS) 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 Postoperative Pain on the Visual Analogue Scale (VAS) 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
Secondary Opioids Consumption Within 48 hours
Secondary Lenght of Hospital Stay up to 2 weeks
Secondary Complications Related to the Pudendal Nerve Block Within 6 weeks
Secondary Direct and Indirect Cost Analysis in Out- and In-patients Ongoing Within the hospital stay
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