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Pudendal Nerve Block for Hemorrhoidectomy

F

Francesco Mongelli

Status

Completed

Conditions

Postoperative Pain
Hemorrhoids

Treatments

Procedure: Local anesthetic (ropivacaine)

Study type

Interventional

Funder types

Other

Identifiers

NCT04251884
CE TI 3222

Details and patient eligibility

About

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

Full 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.

Enrollment

49 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

49 participants in 2 patient groups

Receiving the pudendal nerve block
Experimental group
Treatment:
Procedure: Local anesthetic (ropivacaine)
Not receiving the pudendal nerve block
Active Comparator group
Treatment:
Procedure: Local anesthetic (ropivacaine)

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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