Liposomal Bupivacaine for Postoperative Pain After Craniotomy

NCT ID: NCT06701539

Last Updated: 2024-12-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-12-31

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.

Conditions

Liposome Bupivacaine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Liposome bupivacaine group

Group Type: EXPERIMENTAL

Liposome bupivacaine group

Intervention Type: DRUG

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.

Ropivacaine group

Group Type: ACTIVE_COMPARATOR

Ropivacaine group

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ruquan Han

Head of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Libu20241120

Identifier Type: -

Identifier Source: org_study_id