Pudendal Nerve Block for Hemorrhoidectomy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-01-30

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.

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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.

Conditions

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Hemorrhoids Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Receiving the pudendal nerve block

Group Type EXPERIMENTAL

Local anesthetic (ropivacaine)

Intervention Type PROCEDURE

Patients randomized in the treatment arm will receive a sonography-guided pudendal nerve block

Not receiving the pudendal nerve block

Group Type ACTIVE_COMPARATOR

Local anesthetic (ropivacaine)

Intervention Type PROCEDURE

Patients randomized in the treatment arm will receive a sonography-guided pudendal nerve block

Interventions

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Local anesthetic (ropivacaine)

Patients randomized in the treatment arm will receive a sonography-guided pudendal nerve block

Intervention Type PROCEDURE

Other Intervention Names

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No pudendal nerve block

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