Ultrasound-guided Pudendal Nerve Block for Pain After Hemorrhoidectomy

NCT ID: NCT05889962

Last Updated: 2024-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-26

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hemorrhoids Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients are randomly allocated into pudendal block group or placebo group. Pudendal block group: Patients will receive pudendal nerve block with ropivacaine.

Placebo group: Patients will receive pudendal nerve block with normal saline.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pudendal block group

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

Group Type EXPERIMENTAL

Pudendal nerve block

Intervention Type PROCEDURE

Patients who are randomized in the pudendal block group will receive bilateral pudendal nerve block with ropivacaine.

Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo block

Intervention Type PROCEDURE

Patients who are randomized in the placebo group will receive bilateral pudendal block with normal saline.

Interventions

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Pudendal nerve block

Patients who are randomized in the pudendal block group will receive bilateral pudendal nerve block with ropivacaine.

Intervention Type PROCEDURE

Placebo block

Patients who are randomized in the placebo group will receive bilateral pudendal block with normal saline.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuan-Wen Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University Hospital

Locations

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Taipei Medical University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yuan-Wen Lee, MD, PhD

Role: CONTACT

+886-2-27372181 ext. 8310

Facility Contacts

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Yuan-Wen Lee, MD, PhD

Role: primary

+886-2-27372181 ext. 8310

Other Identifiers

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N202303039

Identifier Type: -

Identifier Source: org_study_id

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