Skip to content

Evaluation of efficacy and safety of Bupivacaine liposomes for accelerated recovery after anal fistula surgery —— A multicenter randomized double-blind controlled study

Evaluation of efficacy and safety of Bupivacaine liposomes for accelerated recovery after anal fistula surgery —— A multicenter randomized double-blind controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106104
Enrollment
Unknown
Registered
2025-07-17
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Anal fistula

Interventions

Control group:After anal fistula surgery, local infiltration anesthesia with a concentration of 0.75% and a dose of 10ml of ropivacaine was used.
Experimental Group 1:Bupivacaine liposomes after anal fistula surgery (20ml
266mg + 10ml of normal saline for local infiltration anesthesia.
Experimental Group 2:After anal fistula surgery, ropivacaine was used for vaginal nerve block at a concentration of 0.75% and a dose of 10ml
Experimental Group 3:Bupivacaine liposomes under ultrasound guidance after anal fistula surgery (20ml
Vaginal nerve block was performed using 266mg + 10ml of normal saline

Sponsors

Affiliated Hospital of Guizhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.The age should be between 18 and 65 years old; 2. Meet the diagnostic criteria for high anal fistula and require surgical treatment; 3. No serious diseases of important organs such as the heart, liver and kidneys (such as NYHA classification of cardiac function grade III-IV, Child-Pugh classification of liver function grade C, chronic renal failure, etc.); 4. No history of allergy to anesthetic drugs; 5. The patient signed the informed consent form and was able to cooperate throughout the entire research process; 6. The operation requires suture treatment.

Exclusion criteria

Exclusion criteria: 1. Patients with severe organ diseases, tumors, or coagulation disorders are not eligible for subarachnoid anesthesia; 2. Pregnant and breastfeeding women; 3. Individuals with mental health conditions; 4. Those currently involved in other research or treatments; 5. Pain caused by other factors besides mixed hemorrhoids; 6. Abnormal inflammatory responses due to physical, chemical, foreign body, necrotic tissue, or allergic reactions; 7. Individuals who have suffered trauma within the past month; 8. Individuals who do not agree to participate in the study.

Design outcomes

Primary

MeasureTime frame
visual analogue scale,VAS;Remedial analgesia rate;

Secondary

MeasureTime frame
Wound healing time;Levels of inflammatory factors;Growth factor level;Wound healing rate;Patient satisfaction score;Incidence of adverse reactions;Safety index;

Countries

China

Contacts

Public ContactZhan Wei

Department of Anorectal Surgery, Affiliated Hospital of Guizhou Medical University

zw16799507@163.com+86 138 8502 3122

Outcome results

None listed

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