Cranial and brain tumor
Conditions
Interventions
Bupivacaine Liposome Group:133 mg bupivacaine liposome 10 ml normal saline for incision infiltration
Bupivacaine Hydrochloride Group:20ml of 0.25% Bupivacaine Hydrochloride for incision infiltration
Sponsors
Northern Theater General Hospital of the Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 80 years; 2.ASA classification I–III; 3.Incision size within the range of 15–20 cm; 4.Patients with a clear preoperative diagnosis and imaging-confirmed supratentorial tumor, planned to undergo supratentorial craniotomy for tumor resection under general anesthesia.
Exclusion criteria
Exclusion criteria: 1.Confirmed or suspected allergy or intolerance to local anesthetics; 2.Unable to understand or use a visual analog scale; 3. Postoperative coma or impaired consciousness; 4.Previous scalp incision or intracranial hypertension; 5.Patients receiving long-term (i.e., more than 2 weeks) anesthetic treatment; 6.History of neurological diseases such as stroke or epilepsy; 7.Hematoma or infection at the incision site; 8. Planned postoperative sedation or GCS (Glasgow Coma Scale) < 14; 9. Participation in another clinical trial involving investigational drugs within 6 months prior to randomization; 10. Diabetic neuropathy, hypertension, coagulation or bleeding disorders, severe peripheral vascular disease, renal insufficiency, liver dysfunction, or other contraindications; 11. Currently pregnant, breastfeeding, or planning pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative 72h resting NRS area under the curve; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean arterial pressure (MAP) and heart rate (HR) before and after each time point: after anesthesia induction (T0), skin incision (T1), bone flap removal (T2), dura mater separation (T3), dura mater suturing (T4), and skin suturing (T5);Timing and dosage of rescue analgesics within 72 hours postoperatively.;Incidence of adverse reactions such as nausea, vomiting, fever, and local anesthetic toxicity in patients;Patient satisfaction;Wound healing status at 2 weeks and 1 month postoperatively.;Incision length;Duration of tracheal tube removal, duration of transfer out of the intensive care unit, length of hospital stay, duration of surgery, etc.;Patient's age, height, weight, and medical conditions;Intraoperative and postoperative adverse events; | — |
Countries
China
Contacts
Public ContactCao Huijuan
The General Hospital of the PLA Northern Theater Command
Outcome results
None listed