Ultrasound-guided Pudendal Nerve Block for Pain After Hemorrhoidectomy

Effects of Ultrasound-guided Pudendal Nerve Block on Postoperative Pain and Quality of Recovery in Patients Undergoing Hemorrhoidectomy

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Hemorrhoids
• Intervention / Treatment: Procedure: Pudendal nerve block; Procedure: Placebo block

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuan-Wen Lee, MD, PhD; Phone Number: 8310 +886-2-27372181; Email: m102093020@tmu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Taipei Medical University Hospital
    • Contact: Yuan-Wen Lee, MD, PhD; Phone Number: 8310 +886-2-27372181; Email: m102093020@tmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pudendal block group; Receiving bilateral pudendal nerve block with 0.5% ropivacaine (10 ml each side)	Procedure: Pudendal nerve block; Patients who are randomized in the pudendal block group will receive bilateral pudendal nerve block with ropivacaine.
Placebo Comparator: Placebo group; Receiving bilateral pudendal nerve block with normal saline (10 ml each side)	Procedure: Placebo block; Patients who are randomized in the placebo group will receive bilateral pudendal block with normal saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first rescue analgesics	Time after hemorrhoidectomy	Up to 7 days after hemorrhoidectomy
Time to the first urination	Time after hemorrhoidectomy	Up to 48 hours after hemorrhoidectomy
Time to the first defecation	Time after hemorrhoidectomy	Up to 48 hours after hemorrhoidectomy
Patient satisfaction with pain control	0 (worst) to 10 (Best)	24 hours after hemorrhoidectomy
Postoperative complications	Pudendal nerve block related complications	Up to 7 days after hemorrhoidectomy

Collaborators and Investigators

• Sponsor: Taipei Medical University Hospital
• Investigators: Principal Investigator: Yuan-Wen Lee, MD, PhD, Taipei Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: June 3, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Pain, Postoperative; Hemorrhoids
• Other Study ID Numbers: N202303039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No