Liposomal Bupivacaine for Postoperative Pain After Craniotomy

Not Applicable

Not yet recruiting

• Conditions: Liposome Bupivacaine
• Interventions: Drug: Liposome bupivacaine group; Drug: Ropivacaine group

• Registration Number: NCT06701539
• Lead Sponsor: Beijing Tiantan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-11-20
• Study First Posted: 2024-11-22
• Status Verified: 2024-12
• Study Start: 2024-12-01
• Last Update Submitted: 2024-12-07
• Last Update Posted: 2024-12-12
• Primary Completion: 2025-06-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liposome bupivacaine group	Liposome bupivacaine group	-
Ropivacaine group	Ropivacaine group	-

Primary Outcome Measures

Name	Time	Method
Time of first incision pain within 72 hours after surgery	72 hours after surgery