Ultrasound-guided Pudendal Nerve Block for Pain After Hemorrhoidectomy

Study Overview
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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.

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

Conditions
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Hemorrhoids, Postoperative Pain

Intervention / Treatment
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* Procedure: Pudendal nerve block
* Procedure: Placebo block


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |