Chronic Pain
Conditions
Keywords
Multichannel electroencephalogram, patients with spinal cord injury, Esketamine, Remifentanil, Flurbiprofen, Spinal cord stimulation
Brief summary
The diagnosis of chronic pain currently lacks objective and quantifiable biomarkers. This study aims to observe the EEG characteristics of patients with chronic pain following spinal cord injury and subsequently administer analgesic interventions with remifentanil, esketamine, flurbiprofen, and spinal cord stimulation. The correlation between EEG features and pain intensity will be examined. The research aims to advance the objectification of chronic pain diagnosis and treatment.
Interventions
DRUGEsketamine(Continuous infusion)
Continuous intravenous infusion of esketamine at a dose of 0.2 mg/(kg · h). Collect resting-state EEG data and NRS scores 40 minutes after administration.
The plasma drug concentrations of remifentanil were set at 0.5 ng/ml, 1 ng/ml, and 1.5 ng/ml. After each plasma drug concentration reached a steady state, the NRS scores were assessed, and resting-state EEG was recorded for at least 5 minutes.
DRUGFlurbiprofen (Single intravenous injection)
Single intravenous injection of Flurbiprofen at a dose of 100 mg. Collect resting-state EEG data and NRS scores 10 minutes after administration.
DEVICESpinal Cord Stimulation
Collect resting-state EEG data and NRS scores with the spinal cord stimulator both turned off and on.
OTHERNo intervention
Collect resting-state EEG data and NRS scores.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Spinal Cord Injury Patients With Chronic Pain Inclusion Criteria: * Age 18 - 65 years old; * American Society of Anesthesiologists (ASA) I-III; * Dextromanual; * Chronic Pain following Spinal Cord Injury; * Spinal cord electrical stimulator implantation under general anesthesia; * Signed informed consent.
Exclusion criteria
* People with mental and behavioral disorders. * Previous history of craniocerebral disease; * History of drug and alcohol abuse; * Patients with aphasia or inability to cooperate with the pain assessments; * Previous adverse reaction to esketamine, opioids or NSAIDs; * Known sever insufficiency of vitals(such as heart failure/renal dysfunction/hepatic failure); * Patients with myasthenia gravis, bronchial asthma, or a predisposition to respiratory depression; * Bleeding tendency; * BMI ≥ 35 kg/m²; * Pregnancy or lactation. Spinal Cord Injury Patients Without Pain Inclusion Criteria: * Age 18 - 65 years old; * American Society of Anesthesiologists (ASA) I-III; * Dextromanual; * Spinal Cord Injury Patients Without Pain; * Spinal cord electrical stimulator implantation under general anesthesia; * Signed informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EEG Spectral Characteristics | During the trial(up to 3 hours for each subject). | EEG power spectrum characteristics of chronic pain in patients with spinal cord injury under esketamine, remifentanil, flurbiprofen administration and spinal cord stimulation, including the δ, θ, α, β, and γ frequency bands. administration, including the δ, θ, α, β, and γ frequency bands. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale(NRS) | During the trial(through study completion, 7 days) | Numerical Rating Scale Assessment Pre- and Post-Analgesic Treatment. The NRS ranges from 0 to 10, with 0-3 indicating mild pain, 4-6 indicating moderate pain, and 7-10 indicating severe pain. |
| Generalized Anxiety Disorder(GAD-7) | During the trial(through study completion, 7 days) | The GAD-7 scale ranges from 0 to 21 points, with a higher score indicating a higher level of anxiety. |
| Patient Health Questionnaire-9(PHQ-9) | During the trial(through study completion, 7 days) | The PHQ-9 scale ranges from 0 to 27 points, with a higher score indicating a higher level of depression. |
Countries
China
Contacts
Primary ContactRuquan Han, M.D., Ph D
Outcome results
None listed