Anesthesia; Adverse Effect, Anesthesia Morbidity
Conditions
Keywords
general anesthesia, sacral plexus block, lumbar plexus block, hip fracture, elderly
Brief summary
Hip fracture is a global public health problem. The postoperative mortality and disability rate of hip fracture is high, and early surgery is still the most effective treatment method, but these patients are often associated with concurrent heart and lung and other organ dysfunction, anesthesia and surgery are extremely risky, mainly associated with high incidence of complications in the pulmonary and cardiovascular system, and anesthesia plays a vital role in ensuring that these patients can safely and effectively get through the perioperative period. The research on the relationship between anesthetic methods and hip fracture surgery prognosis mainly focuses on comparison between neuraxial anesthesia (including spinal anesthesia and epidural anesthesia) and general anesthesia with endotracheal intubation until now. In addition to general anesthesia with endotracheal intubation and neuraxial anesthesia, ultrasound-guided lumbar plexus and sciatic nerve block has been widely used in hip fracture surgery in recent years, especially for some high-risk patients with cardiopulmonary dysfunction. However, it is not clear whether ultrasound-guided combined lumbar plexus and sacral plexus block with sedative anesthesia can improve the prognosis of elderly patients with hip fracture, and in this study, we plan to make a prospective, multicenter, randomized controlled clinical trial to compare the effects of general anesthesia with endotracheal intubation and ultrasound-guided combined lumbar plexus and sacral plexus block with sedative anesthesia on the prognosis of elderly patients with hip fracture to clarify the clinical value of combined lumbar plexus and sacral plexus block with sedative anesthesia in elderly patients with hip fracture.
Interventions
PROCEDUREanesthesia
in this study, we plan to make a prospective, multicenter, randomized controlled clinical trial to compare the effects of general anesthesia with endotracheal intubation and ultrasound-guided combined lumbar plexus and sacral plexus block with sedative anesthesia on the prognosis of elderly patients with hip fracture to clarify the clinical value of combined lumbar plexus and sacral plexus block with sedative anesthesia in elderly patients with hip fracture.
Sponsors
Shanghai 6th People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
77 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥77 years old; 2. First unilateral surgery for hip fracture including femoral neck, intertrochanteric or subtrochanteric fracture; 3. Patient with planned hip fracture surgery within 24-72 h; 4. Patient without peripheral nerve block within 24 h prior to surgery; 5. The ability to receive written informed consent from the patient or patient's legal representative.
Exclusion criteria
1. Refuse to participate; 2. Unable to perform nerve block; 3. Multiple trauma, multiple fractures or other fractures outside the inclusion criteria, such as pathological fractures, pelvic fractures, femur fractures; 4. Prosthetic fracture; 5. Scheduled for bilateral hip fracture surgery; 6. Usage of bone-cement fixation in the surgery; 7. With recent cerebral stroke (\<3 months); 8. Combined with active heart disease (unstable angina, acute myocardial infarction, recent myocardial infarction; decompensated heart failure; symptomatic arrhythmia; severe mitral or aortic stenotic heart disease); 9. Patient with known severe lung and/or airway disease, acute respiratory failure, acute pulmonary infection, and acute attack of bronchial asthma; 10. Current enrolment in another clinical trial; 11. Contraindication for general endotracheal anesthesia(drug allergies to general anesthesia, difficult airway); 12. Contraindication for lumbar and sacral plexus block(infection at the site of needle insertion, coagulopathy, allergy to local anesthetics).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mortality | month 1 | Telephone follow-up will be performed to confirm whether the patient survival or not after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SOFA score(sequential organ failure assessment score) | within 3 days after surgery | Sepsis-related organ failure assessment score, also known as sequential organ failure assessment score (SOFA score), is used to track a person's status during the stay in an intensive care unit (ICU) to determine the extent of a person's organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems.Both the mean and highest SOFA scores are predictors of outcome. An increase in SOFA score during the first 24 to 48 hours in the ICU predicts a mortality rate of at least 50% up to 95%. Scores less than 9 give predictive mortality at 33% while above 11 can be close to or above 95%. |
| the Confusion Assessment Method(CAM) | within 3 days after surgery | The Confusion Assessment Method includes an instrument and diagnostic algorithm for identification of delirium.The CAM instrument assesses the presence, severity, and fluctuation of 9 delirium features:acute onset, inattention, disorganized thinking, altered level of consciousness, disorientation, memory impairment, perceptual disturbances, psychomotor agitation or retardation, and altered sleep-wake cycle. |
| MMSE(Mini-mental State Examination) | within 3 days after surgery | The Mini-Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used in medicine and allied health to screen for dementia. It is also used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time; thus making it an effective way to document an individual's response to treatment. The MMSE test includes simple questions and problems in a number of areas: the time and place of the test, repeating lists of words, arithmetic such as the serial sevens, language use and comprehension, and basic motor skills. |
| High-sensitivity cardiac troponin T(hs-cTnT) | 1 day before surgery,1 and 3 days after surgery | Cardiac troponin is the preferred biomarker for the diagnosis of acute myocardial infarction. A high-sensitivity cardiac troponin T(hs-cTnT) assay permits detection of very low levels of cTnT. |
| Duration of surgery | from the start to the end of the surgery | The time spent on the surgery will be recorded. |
| Intraoperative complications | Intraoperative | 1. Intraoperative hypotension and vasopressor dosage 2. Intraoperative arrhythmia, myocardial ischemia, myocardial infarction, massive hemorrhage, pulmonary embolism and hypoxemia 3. Intraoperative blood loss and blood transfusion volume |
| Incidence of various complications and comprehensive complication index during hospitalization after surgery | up to 8 weeks after the surgery | — |
| Length of stay in ICU and hospital | up to 8 weeks after the surgery | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Barthel Activities of Daily Living Index | on day 30 after discharge and surgery | Functional recovery on day 30 after discharge and surgery, evaluated by Barthel Activities of Daily Living Index. Assesses functional independence, generally in stroke patients. |
| Economic parameters | on day 1 after discharge | Economic parameters including total cost in hospital and expenditure for anesthesia |
| Bauer Patient Satisfaction Questionnaire | on day 3 after surgery | Satisfaction with anesthesia care will be assessed on postoperative day 3 via the Bauer Patient Satisfaction Questionnaire. The questionnaire enables a consistent, reliable and valid evalution of patient satisfaction with anesthesia care. |
Countries
China
Outcome results
None listed