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Liposomal bupivacaine for topical analgesia following excisional hemorrhoidectomy:a randomized controlled trial

Liposomal bupivacaine for topical analgesia following excisional hemorrhoidectomy:a randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075276
Enrollment
Unknown
Registered
2023-08-31
Start date
2023-09-01
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

postoperation pain

Interventions

experimental group:Local perianal infiltration with bupivacaine liposomes
control group:Local perianal infiltration with ropivacaine

Sponsors

the Third Affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Elective hemorrhoidectomy; (2) Age of 18-75 years old, male or female; (3) American Society of Anesthesiologists (ASA) grade ?-? or medically stable grade ?

Exclusion criteria

Exclusion criteria: Exclusion criteria: (1) body mass index (BMI) 30kg/m2. Body mass index = weight/height squared in kg/m2. (2) contraindications to intraspinal anesthesia. (3) difficult airway, acute respiratory infection and asthma attack. (4) uncontrolled severe hypertension or hypotension (systolic blood pressure =160 mmHg, diastolic blood pressure =100 mmHg, systolic blood pressure =90 mmHg, diastolic blood pressure =60 mmHg, any one of these can be met), severe arrhythmia, unstable angina pectoris. Preoperative bradycardia (heart rate 2×ULN). (6) A history of drug use and/or heavy alcohol use, defined as drinking an average of more than 2 units of alcohol per day (1 unit =360 mL of beer or 45 mL of 40% liquor or 150 mL of wine) in the 2 years before the screening period. (7) patients with a history of stroke within 6 months or with sequelae of stroke. (8) history of mental illness or long-term use of psychotropic drugs or chronic analgesics. (8) Allergic to ropivacaine hydrochloride injection, bupivacaine liposome and its drug components. (9) Participated in other drug clinical trials as a subject within the past 3 months. (10) Patients who were deemed by the investigator to be ineligible to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Resting NRS pain score;

Secondary

MeasureTime frame
Exercise NRS pain score;The time of first ambulation after Surgery;the pain score of ambulation on the 1st, 2nd and 3rd day after Surgery;pain score during defecation within 72 hours;the proportion of NRS pain score ?4 during ambulation and defecation;total use of rescue analgesics;Proportion of subjects receiving rescue analgesics;Incision evaluation on postoperative day 1, 3, and 7;

Countries

China

Contacts

Public ContactHuang Yanjuan

the Third Affiliated Hospital of Guangxi Medical University

huangyanjuan66@163.com+86 771 480 8260

Outcome results

None listed

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