Pudendal Nerve Block for Hemorrhoidectomy

Not Applicable

Completed

• Conditions: Hemorrhoids; Postoperative Pain
• Interventions: Procedure: Local anesthetic (ropivacaine)

• Registration Number: NCT04251884
• Lead Sponsor: Francesco Mongelli

Brief Summary

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

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 Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-12-29
• Study Completion: 2020-01-30
• Study First Submitted: 2020-01-30
• Study First Submitted QC: 2020-01-30
• Study First Posted: 2020-02-05
• Results First Submitted: 2020-05-02
• Results First Submitted QC: 2020-06-04
• Results First Posted: 2020-06-05
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Receiving the pudendal nerve block	Local anesthetic (ropivacaine)	-
Not receiving the pudendal nerve block	Local anesthetic (ropivacaine)	-

Primary Outcome Measures

Name	Time	Method
Postoperative Pain on the Visual Analogue Scale (VAS)	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

Name	Time	Method
Postoperative Pain on the Visual Analogue Scale (VAS)	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"
Opioids Consumption	Within 48 hours
Lenght of Hospital Stay	up to 2 weeks
Complications Related to the Pudendal Nerve Block	Within 6 weeks
Direct and Indirect Cost Analysis in Out- and In-patients	Within the hospital stay	Ongoing

Trial Locations

Locations (1)

Ospedale Regionale di Bellinzona e Valli; 🇨🇭 Bellinzona, Switzerland