Modified LPB and SPB vs Classical LPB and SPB

• Sponsor: Peking Union Medical College Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05901415
• Collaborator: (none)
• Enrollment: 30
• Arms: 2
• Anticipated Duration (Months): 24.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, Local	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.	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A modified semi-supine position of combined anterior lumbar and lateral sacral plexus blockA modified semi-supine position of combined anterior lumbar and lateral sacral plexus block
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Jun 7, 2023
• Anticipated Primary Completion Date: Apr 10, 2025
• Anticipated Study Completion Date: Jun 10, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Visual Analogue Scale Score [up to 3 months]

   Compared VAS score of two approaches in patients undergoing anesthesia（VAS from the minimum 0 to the maximum 10 scores）

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Peking Union Medical College Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT05901415
• Other Study ID Numbers: K3105
• First Posted: Jun 13, 2023
• Last Update Posted: Jun 13, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 13, 2023