Ultrasound-guided Pudendal Nerve Block for Pain After Hemorrhoidectomy

Not Applicable

Recruiting

• Conditions: Hemorrhoids; Postoperative Pain
• Interventions: Procedure: Placebo block; Procedure: Pudendal nerve block

• Registration Number: NCT05889962
• Lead Sponsor: Taipei Medical University Hospital

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.

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 Timeline

• Study First Submitted: 2023-05-02
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-03
• Study First Posted: 2023-06-05
• Study Start: 2023-10-26
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26
• Primary Completion: 2024-07
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo block	Receiving bilateral pudendal nerve block with normal saline (10 ml each side)
Pudendal block group	Pudendal nerve block	Receiving bilateral pudendal nerve block with 0.5% ropivacaine (10 ml each side)

Primary Outcome Measures

Name	Time	Method
Postoperative pain score on the numeric rating scale (NRS) at 12 hours	12 hours after hemorrhoidectomy	NRS ranges from 0 (no pain) to 10 (worst pain)
Postoperative pain score on the numeric rating scale (NRS) at 48 hours	48 hours after hemorrhoidectomy	NRS ranges from 0 (no pain) to 10 (worst pain)
Quality of recovery at baseline	Baseline	Quality of recovery-15 questionnaire measures the baseline quality of recovery
Opioid consumption at 12 hours	12 hours after hemorrhoidectomy	Morphine equivalent dose
Opioid consumption at 7 days	7 days after hemorrhoidectomy	Morphine equivalent dose
Quality of recovery at 48 hours	48 hours after hemorrhoidectomy	Quality of recovery-15 questionnaire measures the quality of recovery after surgery
Pain score on the numeric rating scale (NRS) at baseline	Baseline	NRS ranges from 0 (no pain) to 10 (worst pain)
Postoperative pain score on the numeric rating scale (NRS) at 24 hours	24 hours after hemorrhoidectomy	NRS ranges from 0 (no pain) to 10 (worst pain)
Opioid consumption at 6 hours	6 hours after hemorrhoidectomy	Morphine equivalent dose
Postoperative pain score on the numeric rating scale (NRS) at 6 hours	6 hours after hemorrhoidectomy	NRS ranges from 0 (no pain) to 10 (worst pain)
Opioid consumption at 24 hours	24 hours after hemorrhoidectomy	Morphine equivalent dose
Quality of recovery at 7 days	7 days after hemorrhoidectomy	Quality of recovery-15 questionnaire measures the quality of recovery after surgery
Postoperative pain score on the numeric rating scale (NRS) at 7 days	7 days after hemorrhoidectomy	NRS ranges from 0 (no pain) to 10 (worst pain)
Opioid consumption at 48 hours	48 hours after hemorrhoidectomy	Morphine equivalent dose
Quality of recovery at 24 hours	24 hours after hemorrhoidectomy	Quality of recovery-15 questionnaire measures the quality of recovery after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Taipei Medical University Hospital; 🇨🇳 Taipei, Taiwan