Ultrasound-guided Pudendal Nerve Block for Pain After Hemorrhoidectomy

NCT05889962 | Unknown

• 1 other identifier: N202303039
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemorrhoids; Postoperative Pain

Outcome Measures

Primary Outcomes (15)

• Pain score on the numeric rating scale (NRS) at baseline

  NRS ranges from 0 (no pain) to 10 (worst pain)

  Baseline

• Postoperative pain score on the numeric rating scale (NRS) at 6 hours

  NRS ranges from 0 (no pain) to 10 (worst pain)

  6 hours after hemorrhoidectomy

• Postoperative pain score on the numeric rating scale (NRS) at 12 hours

  NRS ranges from 0 (no pain) to 10 (worst pain)

  12 hours after hemorrhoidectomy

• Postoperative pain score on the numeric rating scale (NRS) at 24 hours

  NRS ranges from 0 (no pain) to 10 (worst pain)

  24 hours after hemorrhoidectomy

• Postoperative pain score on the numeric rating scale (NRS) at 48 hours

  NRS ranges from 0 (no pain) to 10 (worst pain)

  48 hours after hemorrhoidectomy

• Postoperative pain score on the numeric rating scale (NRS) at 7 days

  NRS ranges from 0 (no pain) to 10 (worst pain)

  7 days after hemorrhoidectomy

• Opioid consumption at 6 hours

  Morphine equivalent dose

  6 hours after hemorrhoidectomy

• Opioid consumption at 12 hours

  Morphine equivalent dose

  12 hours after hemorrhoidectomy

• Opioid consumption at 24 hours

  Morphine equivalent dose

  24 hours after hemorrhoidectomy

• Opioid consumption at 48 hours

  Morphine equivalent dose

  48 hours after hemorrhoidectomy

• Opioid consumption at 7 days

  Morphine equivalent dose

  7 days after hemorrhoidectomy

• Quality of recovery at baseline

  Quality of recovery-15 questionnaire measures the baseline quality of recovery

  Baseline

• Quality of recovery at 24 hours

  Quality of recovery-15 questionnaire measures the quality of recovery after surgery

  24 hours after hemorrhoidectomy

• Quality of recovery at 48 hours

  Quality of recovery-15 questionnaire measures the quality of recovery after surgery

  48 hours after hemorrhoidectomy

• Quality of recovery at 7 days

  Quality of recovery-15 questionnaire measures the quality of recovery after surgery

  7 days after hemorrhoidectomy

Secondary Outcomes (5)

• Time to first rescue analgesics

  Up to 7 days after hemorrhoidectomy

• Time to the first urination

  Up to 48 hours after hemorrhoidectomy

• Time to the first defecation

  Up to 48 hours after hemorrhoidectomy

• Patient satisfaction with pain control

  24 hours after hemorrhoidectomy

• Postoperative complications

  Up to 7 days after hemorrhoidectomy

Study Arms (2)

Pudendal block group

EXPERIMENTAL

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

Procedure: Pudendal nerve block

Placebo group

PLACEBO COMPARATOR

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

Procedure: Placebo block

Interventions

Pudendal nerve block PROCEDURE

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

Pudendal block group

Placebo block PROCEDURE

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

Placebo group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University Hospital: lead

Study Sites (1)

Taipei Medical University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Hemorrhoids; Pain, Postoperative

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Yuan-Wen Lee, MD, PhD

  Taipei Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuan-Wen Lee, MD, PhD

CONTACT

+886-2-27372181; m102093020@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: June 5, 2023
• Study Start: October 26, 2023
• Primary Completion: July 1, 2024
• Study Completion: September 1, 2024
• Last Updated: February 26, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)