Efficacy and Safety of Stellate Ganglion Block With Lidocaine Combined Platelet-rich Plasma to Treat Chronic Migraine

Capital Medical University

Status: Enrolling

Conditions: Platelet-rich Plasma; Chronic Migraine

Treatments: Other: Not have interventions; Other: No interventions

Study type: Observational

Funder types: Other

Identifiers

NCT06653218

KY-2023-263-03-06

Details and patient eligibility

About

This is a multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study designed to compare the effectiveness and safety of lidocaine combined Platelet-rich plasma (PRP) acting on SGB versus lidocaine alone acting on SGB in patients with CM.

Full description

Chronic migraine (CM) is a disabling disease that causes serious physical and emotional consequences. Previous studies had suggested the efficacy of stellate ganglion block (SGB) with lidocaine in the treatment of CM. However, the side effects related to repeated procedures limit its applications. Platelet-rich plasma (PRP) as an intervention treatment for chronic pain, has shown promising results to alleviate headache within the distribution range of the greater occipital nerve after trauma. So far, there has not been any report on PRP combined with lidocaine acting on SGB for CM. the investigators will conduct this multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study to evaluate the efficacy and safety of lidocaine combined PRP acting on SGB versus lidocaine alone acting on SGB in patients with CM

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 18 to 75 years;
2. BMI between 15 and 35 kg/m2 ;
3. Diagnosed with CM in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3) criteria (Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211);
4. Visual Analogue Scale (VAS; range, 0-10; 0 = no pain and 10 = worst possible pain; higher scores indicate more severe pain) score≥4;
5. Scheduled for lidocaine acting on SGB treatment for CM；
6. Signed informed consent.

Exclusion criteria

1. Previously received SGB treatment;
2. Combined with other types of headaches;
3. Platelet count <105*109/L, use of anticoagulants or antiplatelet agent, coagulation disorders or bleeding disorders;
4. Infection or mass near the puncture site;
5. A history of other neurological disorders;
6. A history of severe cardiopulmonary, hepatic or renal dysfunction;
7. A history of psychological disorders;
8. A history of narcotic drug abuse;
9. Changes in neck anatomic structure caused by radiotherapy or surgery;
10. A history of allergies to any research drugs;
11. Pregnancy or lactation period.

Trial design

200 participants in 2 patient groups

PRP+Lidocaine group

Description:

Patients will be placed in the supine position, with slightly excessive neck extension to receive stellate ganglion block (SGB). And 2.5 ml of PRP combined with 2.5 ml of 1.0% lidocaine will be injected slowly into the ipsilateral stellate ganglion under the guide of ultrasound visualization technology

Treatment:

Other: No interventions

Lidocaine group

Description:

Patients will be placed in the supine position, with slightly excessive neck extension to receive stellate ganglion block (SGB). And 5 ml of 1.0% lidocaine will be injected slowly into the ipsilateral stellate ganglion under the guide of ultrasound visualization technology

Treatment:

Other: Not have interventions