Liposome Bupivacaine
Conditions
Brief summary
Acute postoperative pain is a common postoperative adverse reaction. It refers to acute pain that occurs immediately after surgery and usually lasts no longer than 3-7. Among the craniotomy approaches, patients undergoing supratentorial craniotomy with temporal approach had a higher incidence of moderate to severe pain within 24 hours. In the management of postoperative acute pain, multimodal analgesia is recommended. Liposomal bupivacaine was encapsulated by liposomal vesicles and released slowly, lasting up to 72 hours. The long action time also makes the time window of postoperative acute pain completely covered, thus helping patients better control pain. At present, there is an obvious lack of clinical studies on the effectiveness and specific duration of liposome bupivacaine for postoperative acute pain, especially in neurosurgical craniotomy population with transtemporal incision approach, which is a high-risk group for postoperative pain in neurosurgery.
Interventions
DRUGLiposome bupivacaine group
After standardized anesthesia induction, bilateral scalp nerve block (supprorbital nerve, auriculotemporal nerve, major occipital nerve, minor occipital nerve) was performed with liposome bupivacaine stock solution, and 1-2ml was injected into each block site.
After standardized anesthesia induction, bilateral scalp nerve block (supraorbital nerve, auriculotemporal nerve, major occipital nerve, minor occipital nerve) was administered with 0.5% ropivacaine, and 1-2ml was injected into each block site.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-65 years old; * Patients undergoing craniotomy tumor resection via frontotemporal approach, temporal base approach or temporal occipital approach; * ASA grade I \ III; * Sign informed consent.
Exclusion criteria
* Previous history of combined drug allergy; * Patients with a history of severe chronic pain; * Long-term history of analgesic drug use; * Patients with aphasia and other inability to cooperate with the scale were evaluated; * Patients with mental system diseases; * Patients with incomplete function of vital organs (heart, lung, liver, kidney); * History of drug and drug abuse; * BMI≥35kg/m2; * Pregnant or lactating patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time of first incision pain within 72 hours after surgery | 72 hours after surgery |
Outcome results
None listed