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The Impact of Ultrasound-Guided Bupivacaine Liposome Pudendal Nerve Block on Postoperative Pain and Quality of Life After Hemorrhoidectomy

The Impact of Ultrasound-Guided Bupivacaine Liposome Pudendal Nerve Block on Postoperative Pain and Quality of Life After Hemorrhoidectomy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120443
Enrollment
Unknown
Registered
2026-03-13
Start date
2025-07-01
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-hemorrhoidectomy Pain

Interventions

Pudendal nerve block group (normal saline group, NA group):20ml (266mg) of bupivacaine liposome was applied for ultrasound-guided bilateral pudendal nerve block.
Local Infiltration Group (LA Group).:10 ml of normal saline was used to dilute 266 mg (20 ml) of bupivacaine liposome to a total volume of 30 ml, which was divided into 6 equal parts for local infiltr

Sponsors

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients must meet all of the following criteria to be eligible for enrollment in this study: 1.Understand and agree to participate in this trial, and have provided signed informed consent; 2.Aged >=18 and =3 cm); 4. Body weight >=50 kg for males and >=45 kg for females; 5. Body Mass Index (BMI) >=19.0 and<= 30.0 kg/m²; 6. American Society of Anesthesiologists (ASA) Physical Status Classification of I to III.

Exclusion criteria

Exclusion criteria: Patients meeting **any** of the following criteria will be excluded from this study: 1. Patients with concurrent psychiatric disorders or cognitive dysfunction; 2. Patients with sensory disturbances such as hyperalgesia, or those experiencing other somatic pain that may interfere with postoperative pain assessment; 3. Patients with a history of myocardial infarction or unstable angina within the past six months, or a history of severe arrhythmias (e.g., second-degree or higher atrioventricular block); 4. Patients with diabetic peripheral neuropathy; 5. Patients with abnormal liver function: aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and/or total bilirubin (TBIL) >=1.5× the upper limit of normal (ULN); 6. Patients with known allergies to bupivacaine or other amide-type local anesthetics; 7.Pregnant or lactating female patients, as well as patients planning to conceive within the next six months or unwilling/unable to use effective contraception; 8. Patients considered by the investigator to have any other conditions deemed unsuitable for participation in this trial.

Design outcomes

Primary

MeasureTime frame
NRS Score;

Secondary

MeasureTime frame
NRS score for the most intense pain experienced during each bowel movement and dressing change within 3 days postoperatively;

Countries

China

Contacts

Public ContactXu Hua

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

pshhuaxu@163.com+86 21 6516 1782

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026