A Multicenter, Single-blind, Randomized Controlled Study on the Analgesic Effect of Scalp Nerve Block Using Bupivacaine Liposomes for Postoperative Pain Relief After Craniotomy
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 218
- Locations
- 1
- Primary Endpoint
- Resting Area Under the Curve - Numerical Rating Scale score within 48 hours after surgery
Study Overview
Brief Summary
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. Poor pain management can lead to complications such as restlessness, nausea, hypertension, increased intracranial pressure, and prolonged recovery, potentially resulting in chronic headaches.
Opioids are commonly used to manage this pain but can cause significant side effects like sedation, nausea, and increased intracranial pressure, which can mask serious conditions. Non-opioid medications and scalp infiltration techniques can help but may not provide sufficient pain relief for the duration needed.
Currently, multimodal analgesia, particularly scalp nerve blocks, is advocated in neurosurgical recovery practices. These blocks are effective and simpler to perform, but the effects of long-acting local anesthetics, like bupivacaine, typically last only 24 hours. Since pain often persists longer than that, there is a need for better pain management strategies.
Liposome bupivacaine is a new long-acting local anesthetic approved by the FDA, offering pain relief for up to 72 hours compared to regular bupivacaine's 8-hour duration. Its effectiveness has been confirmed in various nerve block procedures, but it has not been reported for scalp nerve blocks. This study aims to investigate whether liposome bupivacaine scalp nerve blocks can provide long-lasting postoperative pain relief, promote quicker recovery, and reduce complications in neurosurgery patients.
Detailed Description
This study aims to compare the analgesic efficacy and safety of hydrochloride bupivacaine versus liposomal bupivacaine in patients undergoing elective cranial surgery. The protocol is designed to rigorously assess pain management outcomes, recovery quality, and potential complications through a randomized, single-blind, controlled trial.
Study Design and Methodology After a comprehensive screening process, eligible patients are randomized into two groups: the control group receiving hydrochloride bupivacaine and the experimental group receiving a combination of hydrochloride bupivacaine and liposomal bupivacaine. Randomization was implemented using a pre-generated data list to ensure allocation concealment and minimize selection bias. The single-blind design ensures that patients are unaware of their group assignment, while clinicians administering the drugs are informed to ensure proper preparation and delivery.
Preoperative Assessment
Prior to surgery, all subjects undergo a thorough evaluation, including:
- Neurological Assessment: Consciousness levels are assessed using the Glasgow Coma Scale (GCS).
- Laboratory Testing: Electrocardiograms, routine blood tests (e.g., RBC, WBC, hemoglobin, platelet count), and liver/kidney function tests (e.g., ALT, AST, serum creatinine, BUN) are performed to confirm eligibility and detect any underlying conditions.
- Pain and Recovery Familiarization： Patients are introduced to the Numeric Rating Scale (NRS) for pain, the Objective Pain Assessment Scale (OBAS), and the Quality of Recovery-15 (QoR15) scale to standardize postoperative data collection.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years
- •ASA I-III
- •Scheduled for elective cranial surgery
- •Informed consent from the patient or legal representative
Exclusion Criteria
- •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
Arms & Interventions
scalp nerve block with 0.50% hydrochloride bupivacaine
In this group, patients use 0.50% hydrochloride bupivacaine for scalp nerve block
Intervention: scalp nerve block with 0.50% hydrochloride bupivacaine (Drug)
scalp nerve block with 0.25% hydrochloride bupivacaine and 0.67% bupivacaine liposome solution
In this group, patients use 0.25% hydrochloride bupivacaine and 0.67% bupivacaine liposome solution for scalp nerve block
Intervention: scalp nerve block with 0.25% hydrochloride bupivacaine and 0.67% bupivacaine liposome solution (Drug)
Outcomes
Primary Outcomes
Resting Area Under the Curve - Numerical Rating Scale score within 48 hours after surgery
Time Frame: 2 hours post-operation, 4 hours post-operation, 8 hours post-operation, postoperative day 1 8:30, postoperative day 12:00, postoperative day 1 16:00
The Numerical Rating Scale (NRS) is a widely used tool for assessing the intensity of pain. It is a self-reported scale where patients are asked to rate their pain on a numerical scale ranging from 0 to 10. Minimum Value (0): Indicates "No Pain" or the complete absence of pain. This is the best possible outcome for the patient. Maximum Value (10): Indicates "Worst Pain Imaginable" or the most severe pain the patient can conceive. This is the worst possible outcome for the patient.
Secondary Outcomes
- Analgesic use within 48 hours after surgery(within 48 hours after surgery)
- Area Under the Curve - Numerical Rating Scale score during coughing within 48 hours after surgery(within 48 hours after surgery)
- Numerical Rating Scale score during coughing after discharge from Post-Anesthesia Care Unit on Postoperative Day 1 to Postoperative Day 3(Postoperative Day 1 to Day 3)
- Numerical Rating Scale score at rest after discharge from Post-Anesthesia Care Unit on Postoperative Day 1 to Day 3(Postoperative Day 1 to Day 3)
- Overall Benefit Assessment Score for Analgesia within 48 Hours after Surgery(within 48 Hours after Surgery)
- Postoperative Day 5 Quality of Recovery (Quality of Recovery 15)(Postoperative Day 5)
- Nausea and Vomiting within 48 Hours after Surgery(within 48 Hours after Surgery)
Investigators
Diansan Su
Chair of the Department of Anesthesiology
Zhejiang University