Ultrasound-guided Pudendal Nerve Block for Pain After Hemorrhoidectomy

Taipei Medical University

Status: Enrolling

Conditions: Postoperative Pain; Hemorrhoids

Treatments: Procedure: Pudendal nerve block; Procedure: Placebo block

Study type: Interventional

Funder types: Other

Identifiers

NCT05889962

N202303039

Details and patient eligibility

About

The goal of this clinical trial is to investigate the effects of ultrasound-guided pudendal nerve block on postoperative pain, opioid consumption, and quality of recovery in patients receiving Ferguson hemorrhoidectomy.

Full description

Patients who have symptomatic hemorrhoids undergoing Ferguson hemorrhoidectomy under spinal anesthesia will be randomized to receive bilateral ultrasound-guided pudendal nerve block with 0.5% ropivacaine or normal saline immediately after surgery. In addition, intravenous patient controlled analgesia, NSAIDs, and acetaminophen will be used in all participants for postoperative pain control. Postoperative pain on numerical rating scale (NRS), opioid consumption, quality of recovery (QOR-15), patient's satisfaction, and complications will be recorded at 6, 12, 24, 48 hours and 7 days after surgery.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with symptomatic hemorrhoids (grade III and grade IV internal hemorrhoids, mixed hemorrhoids, and external hemorrhoids)
• Age 20 to 65 years old
• American Society of Anesthesiologists (ASA) classification I~III
• Receiving Ferguson hemorrhoidectomy under spinal anesthesia

Exclusion criteria

• Allergy to local anesthetics or analgesics used in this study
• Drug abuse
• Coagulopathy
• An active infection at the injection site
• Patient refusal
• BMI ≥ 30
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Pudendal block group

Experimental group

Description:

Receiving bilateral pudendal nerve block with 0.5% ropivacaine (10 ml each side)

Treatment:

Procedure: Pudendal nerve block

Placebo group

Placebo Comparator group

Description:

Receiving bilateral pudendal nerve block with normal saline (10 ml each side)

Treatment:

Procedure: Placebo block