Pudendal Nerve Block for Hemorrhoidectomy

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

Detailed Description
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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.

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

Conditions
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Hemorrhoids, Postoperative Pain

Intervention / Treatment
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* Procedure: Local anesthetic (ropivacaine)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Receiving the pudendal nerve block<br> | Procedure: Local anesthetic (ropivacaine)<br>* Patients randomized in the treatment arm will receive a sonography-guided pudendal nerve block<br>* Other names: No pudendal nerve block;|
| Active Comparator: Not receiving the pudendal nerve block<br> | Procedure: Local anesthetic (ropivacaine)<br>* Patients randomized in the treatment arm will receive a sonography-guided pudendal nerve block<br>* Other names: No pudendal nerve block;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | Ongoing | Within the hospital stay |