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New treatment option for Brain Tumor Adult
Official title The Analgesic Effect of Scalp Nerve Block Using Bupivacaine Liposomes for Postoperative Pain Relief After Craniotomy
ClinicalTrials.gov ID: NCT07049094
What this study is testing
What is scalp nerve block with 0.25% hydrochloride bupivacaine and 0.67% bupivacaine liposome solution?
scalp nerve block with 0.25% hydrochloride bupivacaine and 0.67% bupivacaine liposome solution is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for brain tumor adult.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- After undergoing craniotomy, 60% to 84% of neurosurgery patients experience moderate to severe acute pain, primarily in the first 48 hours. This pain is mostly superficial, affecting the muscles and soft tissues around the skull.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- ASA I-III
- Scheduled for elective cranial surgery
- Informed consent from the patient or legal representative
You likely can't join if
- Preoperative Glasgow score \< 15
- Preoperative headache with NRS ≥ 4
- Anticipated postoperative sedation or extubation difficulties requiring mechanical ventilation
- Inability to understand the numerical rating scale (NRS)
- Allergies or contraindications to amide local anesthetics, opioids, or NSAIDs
- Long-term opioid or corticosteroid treatment (\> 2 weeks)
See the full eligibility criteria
- Age ≥ 18 years
- ASA I-III
- Scheduled for elective cranial surgery
- Informed consent from the patient or legal representative
- Preoperative Glasgow score \< 15
- Preoperative headache with NRS ≥ 4
- Anticipated postoperative sedation or extubation difficulties requiring mechanical ventilation
- Inability to understand the numerical rating scale (NRS)
- Allergies or contraindications to amide local anesthetics, opioids, or NSAIDs
- Long-term opioid or corticosteroid treatment (\> 2 weeks)
- History of drug abuse in the past 2 years
- Daily alcohol consumption exceeding 3 standard doses
- Mental or cognitive disorders affecting perioperative assessment
- Contraindications for nerve blocks, including infection or tumors at the puncture site, diagnosed diabetic peripheral neuropathy, or inability to cooperate
- Severe liver dysfunction (Child-Pugh class C), severe renal dysfunction (requiring dialysis preoperatively), or severe heart failure (METS \< 4)
- Pregnant or breastfeeding women
- History of craniotomy or pre-existing pathological pain conditions (e.g., migraines, trigeminal neuralgia)
- Incisions for craniotomy extending beyond the area covered by the scalp nerve blocks
- Participation in other clinical trials
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.