The Analgesic Effect of Scalp Nerve Block Using Bupivacaine Liposomes for Postoperative Pain Relief After Craniotomy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
ASA I-III
Scheduled for elective cranial surgery
Informed consent from the patient or legal representative
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
scalp nerve block with 0.25% hydrochloride bupivacaine and 0.67% bupivacaine liposome solution
DrugUsing 0.25% hydrochloride bupivacaine and 0.67% bupivacaine liposome solution for scalp nerve block
scalp nerve block with 0.50% hydrochloride bupivacaine
DrugUsing 0.50% hydrochloride bupivacaine for scalp nerve block
Treatment groups
218 Participants
are divided into 2 treatment groupsGroup A: scalp nerve block with 0.25% hydrochloride bupivacaine and 0.67% bupivacaine liposome solutionExperimental treatment 1 intervention
Group B: scalp nerve block with 0.50% hydrochloride bupivacaineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Resting Area Under the Curve - Numerical Rating Scale score within 48 hours after surgery
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.
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 16:00Secondary outcomes
1
Area Under the Curve - Numerical Rating Scale score during coughing within 48 hours after surgery
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.
Time frame
within 48 hours after surgery2
Numerical Rating Scale score at rest after discharge from Post-Anesthesia Care Unit on Postoperative Day 1 to Day 3
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.
Time frame
Postoperative Day 1 to Day 33
Numerical Rating Scale score during coughing after discharge from Post-Anesthesia Care Unit on Postoperative Day 1 to Postoperative Day 3
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.
Time frame
Postoperative Day 1 to Day 34
Analgesic use within 48 hours after surgery
Time frame
within 48 hours after surgeryOther outcomes
1
Monitoring postoperative adverse events according to the Common Terminology Criteria for Adverse Events version 5.0
Time frame
postoperative day 1 to day 52
Infection and bleeding at the puncture site
Time frame
postoperative day1 to day53
complications of scalp nerve block (ptosis, shallow nasolabial fold, facial asymmetry, speech with air leakage, salivation)
Time frame
postoperative day1 to day5Sponsors and contacts
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Source ClinicalTrials.gov