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Comparison of Bupivacaine Liposome and Modified Cocktail Formulation for Local Infiltration Anesthesia and Analgesia in Promoting Rapid Recovery after Anal Fistula Surgery: A Prospective, Double-Blind, Randomized Controlled Clinical Study Protocol

Comparison of Bupivacaine Liposome and Modified Cocktail Formulation for Local Infiltration Anesthesia and Analgesia in Promoting Rapid Recovery after Anal Fistula Surgery: A Prospective, Double-Blind, Randomized Controlled Clinical Study Protocol

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116519
Enrollment
Unknown
Registered
2026-01-12
Start date
2026-01-15
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

anal fistula

Interventions

Bupivacaine Liposome Group:266 mg of bupivacaine liposome injection in 20 ml is divided into 6 equal doses, with 3 ml administered per injection site, for a total of 18 ml
Modified Cocktail Formulation Group:The Modified Cocktail Formulation group receives a mixture consisting of 1% ropivacaine 10 ml (100 mg/10 ml), dexamethasone 2 mg (5 mg/1 ml), magnesium sulfate inje

Sponsors

Sichuan University, West China Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients suitable for anal atresia surgery. 2. Preoperative ASA classification I–III; 3. Age 15–75 years; no gender restriction; 4. BMI 18–28 kg/m^2; 5. Complete medical records; 6. Both the patient and their family are aware of this study, and the patient voluntarily participates in this experiment and signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Allergic to the medications used in this study, or to local anesthetics or opioids; 2. Have severe heart disease, significant liver or kidney dysfunction, or coagulation disorders; 3. Received analgesic treatment within 24 hours before surgery; 4. Underwent multiple surgical procedures; 5. History of long-term opioid use or drug abuse.

Design outcomes

Primary

MeasureTime frame
Numerical Rating Scale (NRS) Score;—

Secondary

MeasureTime frame
Serum inflammatory marker levels;Assessment of early bowel function recovery;recovery of sphincter function;QOR-15 questionnaire;Wound healing status;complete postoperative pain resolution;adverse reactions;—

Countries

China

Contacts

Public ContactHanlin Gong

Sichuan University, West China Hospital

ncghl999@163.com+86 138 8091 2113

Outcome results

None listed

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