Peripheral nerve block
Conditions
Interventions
Sponsors
The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects who can understand the procedures and methods of this clinical trial (including pain intensity assessment method) voluntarily participate in the trial after full informed consent, and the informed consent form is signed by the subjects themselves or their legal guardian; 2. The informed consent of patients aged 18 - 75 years, regardless of gender; 3. In patients with clinical diagnosis of postherpetic neuralgia, the distribution area of herpes zoster was in the innervation area of one thoracic spinal ganglion segment, and the number of involved ganglion segments was less than or equal to 3; 4. Patients with pain intensity score (NRS) >= 4 at screening stage and before enrollment; 5. Female or male subjects of childbearing age should agree to take effective contraceptive measures by themselves and their partners within 30 days after signing the informed consent.
Exclusion criteria
Exclusion criteria: 1. Before screening, the subjects had any of the following disease history or evidence: (1) History of allergy or idiopathic reaction to amide local anesthetics (such as lidocaine, bupivacaine, tetracaine and ropivacaine), opioids or any component of the drugs used in this study, or allergic constitution (such as allergy to two or more drugs, food or pollen); (2) History of respiratory diseases: acute or chronic bronchial asthma, pulmonary heart disease or respiratory depression; (3) History of neuropsychiatric diseases: brain injury, depression, anxiety, epilepsy, other brain diseases or mental state diseases affecting self-evaluation ability; (4) History of circulatory system diseases: history of heart failure (NYHA grade III and IV), or history of acute myocardial infarction or unstable angina pectoris within 6 months before screening; Or they had a history of coronary angioplasty, coronary stent implantation or coronary artery bypass surgery within 6 months before screening or had a recent cardiac surgery plan; (5) They had a history of substance abuse, needle and blood sickness, or could not tolerate venous puncture for blood collection; 2. Subjects have received any of the following treatments: (1) In the first 3 months (90 days) of screening, those who had undergone major surgery, or those who had undergone surgery that might significantly affect the in vivo process or safety evaluation of the test drug; (2) Participated in the clinical trial of drugs or devices within 3 months (90 days) before screening, and had received the treatment of drugs or devices, or had been included in this trial in the past; (3) One month (30 days) before screening, received long-term or repeated intermittent corticosteroid treatment (continuous for more than 2 weeks or repeated course of treatment); (4) Analgesic drugs (such as local anesthetics, non steroidal anti-inflammatory drugs, oxycodone, ketorolac, diclofenac or pregabalin, etc.) were used 48 hours or 5 half lives before administration; 3. At the time of screening, any of the laboratory test results of the subjects met the following criteria: (1) Hemoglobin content (Hgb) = 2 times of the upper limit of normal value; (4) Serum creatinine (CR) >= 1.5 times of the upper limit of normal value; (5) Creatinine clearance rate was less than 50 ml / min (Cockcroft Gault formula was used); (6) 8 mmol / L; (7) Prothrombin time (PT) > upper limit of normal value + 3S or APTT > upper limit of normal value + 10s. 4. In addition to herpes zoster pain, there were pain diseases or causes in the herpes zoster area or other local areas, which affected the evaluation of pain perception in this trial; 5. There were concurrent infection foci in the site of puncture administration; 6. Positive results of virological examination (hepatitis B e antigen, hepatitis C virus antibody, Treponema pallidum antibody or human immunodeficiency virus antibody) before or during screening; 7. Subjects with poor blood pressure control at screening (systolic blood pressure >= 160mmhg or diastolic blood pressure >= 100mmhg); 8. QTCF interval was significantly prolonged during screening (QTCF interval > 450ms); Other risk factors for TDP (such as heart failure, hypokalemia, bradycardia, inherited long QT syndrome) existed; At the same time, the drugs leading to the prolongation of QT / QTc i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NRS was used to evaluate pain intensity scores within 72 hours after treatment; | — |
Countries
China
Contacts
Public ContactYaping Wang
The Second Xiangya Hospital of Central South University
Outcome results
None listed