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Efficacy and safety of bupivacaine liposomal injection for acute pain after hemorrhoidectomy

Efficacy and safety of bupivacaine liposomal injection for acute pain after hemorrhoidectomy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094525
Enrollment
Unknown
Registered
2024-12-24
Start date
2024-12-31
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Hemorrhoids

Interventions

Control group:Administer a local infiltration injection of 10 ml of 0.75% ropivacaine diluted to a total volume of 30 ml at the incision site
Study Group:Administer a 30 ml diluted solution of bupivacaine liposome for local infiltration injection at the incision site

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Male or female, age >=18 years; 2) Patients with clinical diagnosis of III.~IV. internal hemorrhoids, external hemorrhoids or mixed hemorrhoids combined with prolapse; 3) ASA Grades I-III; 4) 18.5kg/m2<=body mass index (BMI)<=28kg/m^2; 5) Have a full understanding of the purpose and significance of this trial, voluntarily participate in this clinical trial, and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with psychiatric diseases and cognitive dysfunction; 2) Patients with sensory impairments such as hyperalgesia, or other somatic pain that affects postoperative pain assessment; 3) History of myocardial infarction or unstable angina pectoris within half a year, or history of severe arrhythmia (if there is atrioventricular block of grade II or above); 4) patients with diabetic peripheral neuropathy; 5) abnormal liver function: aspartate aminotransferase (AST) or/and alanine aminotransferase (ALT) and/or total bilirubin (TBIL) >=1.5×ULN; 6) Those who are known to be allergic to bupivacaine or other amide local anesthetics; 7) Pregnant and lactating female patients, as well as patients who have a birth plan within half a year and are unwilling or unable to take effective contraceptive measures; 8) Patients with any other factors that, in the opinion of the investigator, are not suitable for participation in this trial.

Design outcomes

Primary

MeasureTime frame
The Area Under the Curve of the Pain Intensity Score on the Numerical Rating Scale;

Secondary

MeasureTime frame
Resting and movement state NRS scores ;

Countries

China

Contacts

Public ContactGang Liu

Tianjin Medical University General Hospital

lg1059@tmu.edu.cn+86 133 8909 8101

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026