Liposomal Bupivacaine for Postoperative Pain After Craniotomy

NCT06701539 | Not Yet Recruiting

• 1 other identifier: Libu20241120
• Study Type: interventional
• Target: 106
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Time of first incision pain within 72 hours after surgery

  72 hours after surgery

Study Arms (2)

Liposome bupivacaine group

EXPERIMENTAL

Drug: Liposome bupivacaine group

Ropivacaine group

ACTIVE COMPARATOR

Drug: Ropivacaine group

Interventions

Liposome bupivacaine group 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.

Liposome bupivacaine group

Ropivacaine group 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.

Ropivacaine group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Anesthesiology

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 22, 2024
• Study Start: December 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 31, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12