osteoporotic vertebralcompression fracture,OVCF
Conditions
Interventions
Osselidine group:Intravenous oxelidine
Remifentanil group (control group):Intravenous remifentanil
Saline placebo group (blank control):Intravenous saline
Sponsors
Mindong Hospital of Ningde City
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Those diagnosed with osteoporotic vertebral fracture and need to be treated with local anesthesia strengthened vertebral (kyphoplasty) surgery, gender and age are not limited; Indications for minimally invasive vertebral body enhancement surgery include the acute phase (6 weeks post-injury) in which the pain is severe and immobile despite refractory conservative treatment; Unstable vertebral compression fracture or vertebral fracture that does not heal; cystic changes within the vertebral bodies, vertebral necrosis (osteoporotic Kummell's disease without nerve damage); It is not advisable to stay in bed for a long time; Able to tolerate surgery. Referring to the criteria recommended by the American Society of Interventional Radiology in 2014, "ineffective conservative treatment" is defined as: the pain caused by vertebral compression fracture causes the pain to persist at a level that prevents movement in patients who are unable to exercise after 24 hours of analgesic treatment; The pain caused by vertebral compression fracture was severe to the extent that physical therapy could not relieve it, and the pain continued at a level that prevented movement after 24 hours of analgesic treatment. Pain due to vertebral compression fractures with necessary analgesic treatment can lead to unacceptable adverse effects such as excessive sedation, confusion, or constipation. If an elderly patient chooses surgery, it is recommended to complete it as soon as possible after the injury (age> 65 years, within 6 weeks; age >70 years, within 3 weeks) to shorten the duration of bed rest and reduce complications.
Exclusion criteria
Exclusion criteria: Present with one of the following: painless, old osteoporotic vertebral compression fracture; Patients who cannot tolerate surgery; Patients with bronchial asthma, chronic obstructive pulmonary disease, sleep apnea, severe liver and kidney damage; Patients with substance abuse, opioid dependence, or opioid tolerance; Patients with paralytic ileus, mechanical ileus, cholelithiasis and biliary colic, sinus bradycardia; ASA grade =4; There were serious cardiopulmonary and cerebral systemic diseases before operation, such as severe hypertension (crisis), severe diabetes (ketosis, acidosis), severe coronary heart disease, respiratory failure, pulmonary hypertension, and severe arrhythmia (atrial fibrillation). Grade II and above atrioventricular block, sick sinus syndrome, etc.), severe heart valve disease, heart failure, kidney failure, stroke and myocardial infarction within 6 months, Alzheimer's disease, Parkinson's disease, mental illness, myasthenia gravis, etc. History of chronic pain; Patients with a history of allergy to the drugs used in this study; History of inflammatory bowel disease or peptic ulcer; Abnormal coagulation function; Patients with METs<4; Tumor patients receiving radiotherapy and chemotherapy; Patients who refused or were unable to participate in the study; Patients enrolled in other studies within 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain VAS score; | — |
Countries
China
Contacts
Public ContactChenfang Miao
Mindong Hospital of Ningde City
Outcome results
None listed