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Comparison of the effects with Liposomal Bupivacaine versus standard Bupivacaine on Anesthesia intrathecal application-A randomized controlled study

Comparison of the effects with Liposomal Bupivacaine versus standard Bupivacaine on Anesthesia intrathecal application-A randomized controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108264
Enrollment
Unknown
Registered
2025-08-27
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-01

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

Conditions

Pain

Interventions

Bupivacaine liposome group:During the skin suturing procedure, 10 ml of a total of 133 mg of bupivacaine liposome was administered via the epidural route.
Bupivacaine hydrochloride group:During the skin suturing procedure, 10 ml of 0.0938% bupivacaine hydrochloride was administered via the epidural route.

Sponsors

Xiamen Hospital Affiliated to Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18~75 years old (male and non-pregnant women); 2. ASA grade I~III; 3. Elective surgery; 4. Voluntarily participate and sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1. Body weight less than 40kg, body mass index greater than or equal to 35kg/m^2; 2. Patients who are known to be allergic to local anesthetics used in this study; 3. History of allergy to opioids or severe allergy to other drugs; 4. History of opioid abuse and long-term use of psychotropic drugs; 5. Preoperative patients with severe heart disease (NYHA cardiac function classification >3), severe renal insufficiency (serum creatinine >1.8mg/dL (159.1µmol/L) or receiving renal function replacement therapy), severe hepatic insufficiency (modified Child-Pugh grade C); 6. History of clinically significant disease (determined by investigation results); 7. Blood donation or massive blood loss within 6 weeks before screening, family history of thrombosis, or participation in drug research within 30 days 8. Epidural puncture is contraindicated; 9. Accompanied by poor preoperative blood glucose control of diabetes (fasting blood glucose control not within the range of 3.9-13.8 mmol/L (68-250 mg/dL)) 10. Pregnant women; 11. Preoperative coagulation dysfunction; 12. Refusing to sign the informed consent form; 13. Those who cannot be selected for any reason in the opinion of the investigator.

Design outcomes

Primary

MeasureTime frame
Total consumption of opioid drugs for patient-controlled analgesia in 48 hours after surgery;

Secondary

MeasureTime frame
The total consumption of opioid drugs for patient-controlled analgesia at 24 hours and 72 hours after surgery;The time from the end of the surgery to the first use of the pain relief pump for emergency pain relief;The incidence of nausea 24 hours and 48 hours after the operation;The incidence of vomiting 24 hours and 48 hours after the operation;The Recovery-15 scores at the time points of before the operation, 24 hours after the operation and 48 hours after the operation;The Numerical Rating Scale scores at 24 hours, 48 hours, and 72 hours after the operation;

Countries

China

Contacts

Public ContactLiang Chao

Zhongshan Hospital Affiliated to Fudan University

Superwm226@126.com+86 159 2167 9955

Outcome results

None listed

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