Modified LPB and SPB vs Classical LPB and SPB

Anesthesia, Local Clinical Trial

Official title:

Combined Anterior Lumbar Plexus and Lateral Sacral Plexus Block in a Semi-supine Position for Hip Fracture Surgery in Elderly Patients: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05901415
• Other study ID #: K3105
• Status: Recruiting
• Phase: N/A
• Start date: August 14, 2023
• Est. completion date: June 10, 2025

Study information

• Verified date: December 2023
• Source: Peking Union Medical College Hospital
• Contact: Heyu Ji, MD
• Phone: +8618374808445
• Email: jiheyu1929[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The timing of surgery for hip fractures is crucial for elderly patients. The mortality rate for elderly patients after hip fracture is high, and anesthetic decisions significantly affect the patient's outcome. Regional anesthesia has been shown to have better outcomes than general anesthesia. We proposed a newly developed modified position for the ultrasound-guided combined anterior lumbar and lateral sacral plexus block technique that offers benefits, including minimizing interference with circulation and anesthesia, avoiding position change and pain, and providing effective postoperative analgesia.

Description:

The increasing proportion of elderly patients requiring surgery, particularly for hip fractures, is common among the elderly. The timing of surgery for hip fractures is crucial and most require surgical treatment. The mortality rate for elderly patients after hip fracture is high, and anesthetic decisions significantly affect the patient's outcome. Elderly patients have decreased physiological function and are more susceptible to postoperative complications, such as delirium, constipation, pressure sores, and catheter-related infections. Regional anesthesia has been shown to have better outcomes than general anesthesia. We proposed a newly developed modified position for the ultrasound-guided combined anterior lumbar and lateral sacral plexus block that offers benefits, including minimizing interference with circulation and anesthesia, avoiding position change and pain, and providing effective postoperative analgesia. The study validates the feasibility and effectiveness of this technique for elderly hip fracture surgery and compares it with a traditional lumbar-sacral plexus nerve block, providing a fresh perspective on anesthesia for this type of surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 10, 2025
• Est. primary completion date: April 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 100 Years

Eligibility

Inclusion Criteria:

Patients over 70 years of age. ASA classification grades II-IV. Patients with hip fractures requiring surgery (intramedullary nailing of intertrochanteric fractures).

Exclusion Criteria:

Peripheral neuropathy or other neurological disorders affecting the nerves involved in the block; Serve coagulopathy or platelet dysfunction; Inability to perform puncture due to infection, wound, or other reasons at the puncture site; Allergy to local anesthetics or any other medications used in the block; Inability to cooperate or communicate with the healthcare provider during the procedure; Patients or their families who cannot understand the conditions and objectives of the study.

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

Procedure:
• Combined anterior lumbar plexus and lateral sacral plexus block in a semi-supine position
We proposed a modified approach of combined anterior LPB and lateral SPB with the patients posed in a semi-supine position aiming to reduce the pain and discomfort induced by position changing effectively.
• Combined anterior lumbar plexus and lateral sacral plexus block in a classical position.
Patients posed in a classical position and received combined anterior LPB and lateral SPB.

Locations

Country	Name	City	State
China	Heyu Ji	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale Score	Compared VAS score of two approaches in patients undergoing anesthesia(VAS from the minimum 0 to the maximum 10 scores)	up to 3 months