Clinical trial NCT05889962: Ultrasound-guided Pudendal Nerve Block for Pain After Hemorrhoidectomy
Official title: Effects of Ultrasound-guided Pudendal Nerve Block on Postoperative Pain and Quality of Recovery in Patients Undergoing Hemorrhoidectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemorrhoids
Postoperative Pain
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain score on the numeric rating scale (NRS) at baseline
timeFrame: Baseline
measure: Postoperative pain score on the numeric rating scale (NRS) at 6 hours
timeFrame: 6 hours after hemorrhoidectomy
measure: Postoperative pain score on the numeric rating scale (NRS) at 12 hours
timeFrame: 12 hours after hemorrhoidectomy
measure: Postoperative pain score on the numeric rating scale (NRS) at 24 hours
timeFrame: 24 hours after hemorrhoidectomy
measure: Postoperative pain score on the numeric rating scale (NRS) at 48 hours
timeFrame: 48 hours after hemorrhoidectomy
measure: Postoperative pain score on the numeric rating scale (NRS) at 7 days
timeFrame: 7 days after hemorrhoidectomy
measure: Opioid consumption at 6 hours
timeFrame: 6 hours after hemorrhoidectomy
measure: Opioid consumption at 12 hours
timeFrame: 12 hours after hemorrhoidectomy
measure: Opioid consumption at 24 hours
timeFrame: 24 hours after hemorrhoidectomy
measure: Opioid consumption at 48 hours
timeFrame: 48 hours after hemorrhoidectomy
measure: Opioid consumption at 7 days
timeFrame: 7 days after hemorrhoidectomy
measure: Quality of recovery at baseline
timeFrame: Baseline
measure: Quality of recovery at 24 hours
timeFrame: 24 hours after hemorrhoidectomy
measure: Quality of recovery at 48 hours
timeFrame: 48 hours after hemorrhoidectomy
measure: Quality of recovery at 7 days
timeFrame: 7 days after hemorrhoidectomy
Secondary outcomes:
measure: Time to first rescue analgesics
timeFrame: Up to 7 days after hemorrhoidectomy
measure: Time to the first urination
timeFrame: Up to 48 hours after hemorrhoidectomy
measure: Time to the first defecation
timeFrame: Up to 48 hours after hemorrhoidectomy
measure: Patient satisfaction with pain control
timeFrame: 24 hours after hemorrhoidectomy
measure: Postoperative complications
timeFrame: Up to 7 days after hemorrhoidectomy
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
affiliation: Taipei Medical University Hospital
name: Yuan-Wen Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: