Pudendal Nerve Block for Hemorrhoidectomy

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04251884
• Other study ID #: CE TI 3222
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hemorrhoids
• Postoperative Pain

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