Clinical trial NCT03318133: Comparison of CLSB With Sedation Versus General Endotracheal Anesthesia on Postoperative Outcomes in Elderly Patients Undergoing Hip Fracture Surgery
Official title: Comparison of Combined Lumbar and Sacral Plexus Block With Sedation Versus General Endotracheal Anesthesia on Postoperative Outcomes in Elderly Patients Undergoing Hip Fracture Surgery(CLSB-HIPELD): Rationale and Design of a Prospective, Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia Morbidity
Anesthesia; Adverse Effect
Keywords: general anesthesia
sacral plexus block
lumbar plexus block
hip fracture
elderly
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 1086
Sex: ALL
Minimum age (years): 77
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: mortality
timeFrame: month 1
measure: mortality
timeFrame: months 3
measure: mortality
timeFrame: month 6
measure: mortality
timeFrame: month 12
Secondary outcomes:
measure: Duration of surgery
timeFrame: from the start to the end of the surgery
measure: Intraoperative complications
timeFrame: Intraoperative
measure: Incidence of various complications and comprehensive complication index during hospitalization after surgery
timeFrame: up to 8 weeks after the surgery
measure: SOFA score(sequential organ failure assessment score)
timeFrame: within 3 days after surgery
measure: Length of stay in ICU and hospital
timeFrame: up to 8 weeks after the surgery
measure: the Confusion Assessment Method(CAM)
timeFrame: within 3 days after surgery
measure: MMSE(Mini-mental State Examination)
timeFrame: within 3 days after surgery
measure: High-sensitivity cardiac troponin T(hs-cTnT)
timeFrame: 1 day before surgery,1 and 3 days after surgery
Other outcomes:
measure: Bauer Patient Satisfaction Questionnaire
timeFrame: on day 3 after surgery
measure: Economic parameters
timeFrame: on day 1 after discharge
measure: Barthel Activities of Daily Living Index
timeFrame: on day 30 after discharge and surgery
Locations:
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
Study officials:
References:
citation: Zhang J, Wang X, Zhang H, Shu Z, Jiang W. Comparison of combined lumbar and sacral plexus block with sedation versus general anaesthesia on postoperative outcomes in elderly patients undergoing hip fracture surgery (CLSB-HIPELD): study protocol for a prospective, multicentre, randomised controlled trial. BMJ Open. 2019 Mar 30;9(3):e022898. doi: 10.1136/bmjopen-2018-022898.