Comparison of CLSB With Sedation Versus General Endotracheal Anesthesia on Postoperative Outcomes in Elderly Patients Undergoing Hip Fracture Surgery

NCT ID: NCT03318133

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1086 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-04
• Study Completion Date: 2023-12-31

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.

Conditions

Anesthesia Morbidity; Anesthesia; Adverse Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GA group

general anesthesia(GA) group:

1. Open peripheral vein fluid infusion, radial arterial cannulation under local lidocaine anesthesia and arterial blood pressure monitoring

2. Propofol (1.5-3mg/kg), cis-atracurium(0.1-0.15mg/kg) and sulfentanyl(0.2-0.6μg/kg) anesthesia-induced intubation, mechanical ventilation to maintain normal PETCO2

3. Use sevoflurane, propofol and sulfentanyl to maintain anesthesia, and add cis-atracurium as needed

4. Transfer to ICU after surgery

Group Type: EXPERIMENTAL

anesthesia

Intervention Type: PROCEDURE

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.

CLSB group

combined lumbar plexus and sacral plexus block(CLSB) group:

1. Open peripheral vein fluid infusion

2. In lateral position (affected side upward), ultrasound-guided lumbar plexus block (0.375% ropivacaine, Lumbar 2-3 or/and 3-4vertebral space level, 25ml), then sacral plexus block (0.375% ropivacaine, 20ml)

3. Radial arterial cannulation under local lidocaine anesthesia and arterial blood pressure monitoring, and blockade effectiveness was evaluated 30min after nerve block

4. After reaching satisfactory blockade, target-controlled infusion of propofol was used to maintain Ramsay sedation score between 5-6 points, monitoring PETCO2 through nasopharyngeal airway, maintain autonomous respiration, and add small-dose fentanyl (10-20μg/time) as needed

5. Transfer to ICU after surgery

Group Type: EXPERIMENTAL

anesthesia

Intervention Type: PROCEDURE

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

anesthesia

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.

Intervention Type: PROCEDURE

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.

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).

Exclusion Criteria

1. Refuse to participate;

2. Unable to perform nerve block;

• Minimum Eligible Age: 77 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 6th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiaofeng WANG

Attending doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Xiaofeng XF Wang, MD

Role: primary

240483680@qq.com

+8618930170135

References

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.

Reference Type: DERIVED

PMID: 30928924 (View on PubMed)

Other Identifiers

2016-28(2)

Identifier Type: -

Identifier Source: org_study_id