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The impact of bupivacaine liposome infiltration at the incision site and biliary bed spraying on postoperative pain management and recovery in patients undergoing day-case laparoscopic cholecystectomy

The impact of bupivacaine liposome infiltration at the incision site and biliary bed spraying on postoperative pain management and recovery in patients undergoing day-case laparoscopic cholecystectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101570
Enrollment
Unknown
Registered
2025-04-27
Start date
2025-05-10
Completion date
Unknown
Last updated
2025-05-05

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

Conditions

Pain after laparoscopic cholecystectomy

Interventions

Bupivacaine liposome group:Prior to closing the surgical incision, a 10-mL dose of bupivacaine liposome is slowly and evenly sprayed onto the gallbladder bed using an irrigation device. Additionally,
Ropivacaine group:Before closing the surgical incision, use the irrigation device to slowly and evenly spray 10 mL of 0.5% ropivacaine on the gallbladder bed. Use 9 mL of 0.5% ropivacaine for incision
Saline Solution Group :Prior to closing the surgical incision, the irrigation device is used to slowly and evenly spray 10 mL of normal saline onto the gallbladder bed. Additionally, 9 mL of normal s

Sponsors

The Second Affiliated Hospital of Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Daytime patients scheduled for laparoscopic cholecystectomy; (2) Age 18-65 years old, gender not limited; (3) BMI 18-28 kg/m^2; (4) ASA grade I-III patients; (5) Able to understand the procedures and methods of this study, willing to sign the informed consent form and strictly abide by the experimental protocol to complete this study.

Exclusion criteria

Exclusion criteria: (1) Known or suspected allergy or contraindication to any component of the investigational drug; (2) Currently or previously addicted to drugs; (3) Severe diseases of heart, lung, liver, kidney, etc.; (4) Currently participating in other clinical studies of drugs; (5) Subjects considered by the investigator to have other factors that make them unsuitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
The NRS score for abdominal wall pain at rest 24 hours after surgery;

Secondary

MeasureTime frame
The NRS scores of abdominal wall pain at rest at 6, 12, 48 and 72 hours after surgery;The NRS scores for visceral pain at rest recorded at 6, 12, 24, 48, and 72 hours post-surgery;NRS scores for pain during active coughing at 6, 12, 24, 48, and 72 hours post-surgery;The number of discharged cases within 24 hours after surgery;The types and dosages of postoperative analgesics used;Time to first ambulation after getting out of bed ;Duration from surgery to hospital discharge ;Number of patients experiencing adverse events ;Satisfaction rating;

Countries

China

Contacts

Public ContactChen Zhou

The Second Affiliated Hospital of Kunming Medical University

673871042@qq.com+86 158 0886 6927

Outcome results

None listed

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