Modified LPB and SPB vs Classical LPB and SPB

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia, Local
• Intervention / Treatment: Procedure: Combined anterior lumbar plexus and lateral sacral plexus block in a semi-supine position; Procedure: Combined anterior lumbar plexus and lateral sacral plexus block in a classical position.

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heyu Ji, MD; Phone Number: +8618374808445; Email: jiheyu1929@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Heyu Ji
      • Contact: heyu ji; Phone Number: +8618374808445; Email: jiheyu1929@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A Modified Semi-supine Position of Combined Anterior Lumbar and Lateral Sacral Plexus Block; Patients were placed in a supine position with a small pad put under the upper body at the surgical side, then they received a combined anterior lumbar and lateral sacral plexus block.	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.
Sham Comparator: A classical Position of Combined Anterior Lumbar and Lateral Sacral Plexus Block; Patients received a combined anterior lumbar and lateral sacral plexus block in a lateral position.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Xulei Cui, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2023
• Primary Completion (Estimated): April 10, 2025
• Study Completion (Estimated): June 10, 2025

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: June 4, 2023
• First Posted (Actual): June 13, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: K3105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No