Electroencephalographic Characteristics of Chronic Pain in Patients With Spinal Cord Injury

Capital Medical University

Status: Not yet enrolling

Conditions: Chronic Pain

Treatments: Drug: Flurbiprofen (Single intravenous injection); Other: No intervention; Drug: Esketamine(Continuous infusion); Drug: Remifentanil (Target-Controlled Infusion); Device: Spinal Cord Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06531837

zz20240512

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Patients without pain

Sham Comparator group

Treatment:

Other: No intervention

Patients with chronic pain treated with esketamine

Experimental group

Treatment:

Device: Spinal Cord Stimulation

Drug: Esketamine(Continuous infusion)

Patients with chronic pain treated with remifentanil

Experimental group

Treatment:

Device: Spinal Cord Stimulation

Drug: Remifentanil (Target-Controlled Infusion)

Patients with chronic pain treated with flurbiprofen

Experimental group

Treatment:

Device: Spinal Cord Stimulation

Drug: Flurbiprofen (Single intravenous injection)