Modified LPB and SPB vs Classical LPB and SPB

NCT05901415 | Unknown DMC

• 1 other identifier: K3105
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

A Modified Semi-supine Position of Combined Anterior Lumbar and Lateral Sacral Plexus Block

EXPERIMENTAL

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

A classical Position of Combined Anterior Lumbar and Lateral Sacral Plexus Block

SHAM COMPARATOR

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.

Interventions

Combined anterior lumbar plexus and lateral sacral plexus block in a semi-supine position PROCEDURE

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.

A Modified Semi-supine Position of Combined Anterior Lumbar and Lateral Sacral Plexus Block

Combined anterior lumbar plexus and lateral sacral plexus block in a classical position. PROCEDURE

Patients posed in a classical position and received combined anterior LPB and lateral SPB.

A classical Position of Combined Anterior Lumbar and Lateral Sacral Plexus Block

Eligibility Criteria

• Age: 70 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Heyu Ji

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

• Ji H, Cui X. A modified approach of combined anterior lumbar plexus block with lateral sacral plexus block in a semi lateral supine position for lower limb fracture patients: a case series. BMC Anesthesiol. 2025 Feb 14;25(1):74. doi: 10.1186/s12871-025-02943-0.

  PMID: 39953416 DERIVED

Study Officials

• Xulei Cui, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heyu Ji, MD

CONTACT

+8618374808445; jiheyu1929@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A modified semi-supine position of combined anterior lumbar and lateral sacral plexus block

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: June 13, 2023
• Study Start: August 14, 2023
• Primary Completion: April 10, 2025
• Study Completion: June 10, 2025
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)