Liposomal Bupivacaine for Postoperative Pain After Craniotomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Liposome bupivacaine group, Ropivacaine group.
- Who it may be relevant to
- Registry conditions: Liposome Bupivacaine. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Nerve Block With Liposome Bupivacaine for Postoperative Pain After Craniotomy: A Randomized Control Trial
Overview
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
- Drug Liposome 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. - Drug Ropivacaine group
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.
Primary outcome measures
- Time of first incision pain within 72 hours after surgery [Time frame: 72 hours after surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06701539 · Libu20241120