Ultrasound-guided Pudendal Nerve Block for Pain After Hemorrhoidectomy

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05889962
• Other study ID #: N202303039
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2023
• Est. completion date: September 2024

Study information

• Verified date: June 2023
• Source: Taipei Medical University Hospital
• Contact: Yuan-Wen Lee, MD, PhD
• Phone: +886-2-27372181
• Email: m102093020[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhoids
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Pudendal nerve block
Patients who are randomized in the pudendal block group will receive bilateral pudendal nerve block with ropivacaine.
• Placebo block
Patients who are randomized in the placebo group will receive bilateral pudendal block with normal saline.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score on the numeric rating scale (NRS) at baseline	NRS ranges from 0 (no pain) to 10 (worst pain)	Baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Opioid consumption at 6 hours	Morphine equivalent dose	6 hours after hemorrhoidectomy
Primary	Opioid consumption at 12 hours	Morphine equivalent dose	12 hours after hemorrhoidectomy
Primary	Opioid consumption at 24 hours	Morphine equivalent dose	24 hours after hemorrhoidectomy
Primary	Opioid consumption at 48 hours	Morphine equivalent dose	48 hours after hemorrhoidectomy
Primary	Opioid consumption at 7 days	Morphine equivalent dose	7 days after hemorrhoidectomy
Primary	Quality of recovery at baseline	Quality of recovery-15 questionnaire measures the baseline quality of recovery	Baseline
Primary	Quality of recovery at 24 hours	Quality of recovery-15 questionnaire measures the quality of recovery after surgery	24 hours after hemorrhoidectomy
Primary	Quality of recovery at 48 hours	Quality of recovery-15 questionnaire measures the quality of recovery after surgery	48 hours after hemorrhoidectomy
Primary	Quality of recovery at 7 days	Quality of recovery-15 questionnaire measures the quality of recovery after surgery	7 days after hemorrhoidectomy
Secondary	Time to first rescue analgesics	Time after hemorrhoidectomy	Up to 7 days after hemorrhoidectomy
Secondary	Time to the first urination	Time after hemorrhoidectomy	Up to 48 hours after hemorrhoidectomy
Secondary	Time to the first defecation	Time after hemorrhoidectomy	Up to 48 hours after hemorrhoidectomy
Secondary	Patient satisfaction with pain control	0 (worst) to 10 (Best)	24 hours after hemorrhoidectomy
Secondary	Postoperative complications	Pudendal nerve block related complications	Up to 7 days after hemorrhoidectomy