Anesthesia, LocalNCT05901415
Modified LPB and SPB vs Classical LPB and SPB
A study testing Combined anterior lumbar plexus and lateral sacral plexus block in a semi-supine position and Combined anterior lumbar plexus and lateral sacral plexus block in a classical position. in people with Anesthesia, Local, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 70 to 100 years
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Combined anterior lumbar plexus and lateral sacral plexus block in a semi-supine position and Combined anterior lumbar plexus and lateral sacral plexus block in a classical position.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 14 Aug 2023to 10 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients over 70 years of age. ASA classification grades II-IV. Patients with hip fractures requiring surgery (intramedullary nailing of intertrochanteric fractures).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Heyu Ji
Beijing, Beijing Municipality, 100730
heyu ji, +8618374808445, jiheyu1929@163.com
About this study
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
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.
Read the 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.
- Conditions
- Anesthesia, Local
- Being tested
- Combined anterior lumbar plexus and lateral sacral plexus block in a semi-supine position, Combined anterior lumbar plexus and lateral sacral plexus block in a classical position.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined anterior lumbar plexus and lateral sacral plexus block in a semi-supine positionProcedure or surgery
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.Procedure or surgery
Patients posed in a classical position and received combined anterior LPB and lateral SPB.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Combined anterior lumbar plexus and lateral sacral plexus block in a classical position. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale Score
Compared VAS score of two approaches in patients undergoing anesthesia（VAS from the minimum 0 to the maximum 10 scores）
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start14 Aug 2023
- Primary completion10 Apr 2025 (estimated)
- Study completion10 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A modified semi-supine position of combined anterior lumbar and lateral sacral plexus block
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xulei Cui, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901415
- Sponsor's protocol ID
- K3105
- Status last verified
- Dec 2023
- First submitted
- 17 Apr 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39953416
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05901415
- Acronym / sponsor ID
- K3105
- Conditions
- Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 10 Apr 2025 (estimated)
- Study completion
- 10 Jun 2025 (estimated)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- A modified semi-supine position of combined anterior lumbar and lateral sacral plexus block
| Arm | Type | Receives |
|---|---|---|
| A Modified Semi-supine Position of Combined Anterior Lumbar and Lateral Sacral Plexus Block | Experimental | Procedure: Combined anterior lumbar plexus and lateral sacral plexus block in a semi-supine positionPatients 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. |
| A classical Position of Combined Anterior Lumbar and Lateral Sacral Plexus Block | Sham comparator | Procedure: Combined anterior lumbar plexus and lateral sacral plexus block in a classical position.Patients received a combined anterior lumbar and lateral sacral plexus block in a lateral position. |
Who may qualify
- Ages
- 70 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients over 70 years of age. ASA classification grades II-IV. Patients with hip fractures requiring surgery (intramedullary nailing of intertrochanteric fractures).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined anterior lumbar plexus and lateral sacral plexus block in a semi-supine positionWe 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. | Procedure or surgery | 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.Patients posed in a classical position and received combined anterior LPB and lateral SPB. | Procedure or surgery | A classical Position of Combined Anterior Lumbar and Lateral Sacral Plexus Block |
Primary outcome
Visual Analogue Scale Score
Time frame: up to 3 months
Compared VAS score of two approaches in patients undergoing anesthesia（VAS from the minimum 0 to the maximum 10 scores）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Derived from this study: PubMed 39953416Ji 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xulei Cui, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined anterior lumbar plexus and lateral sacral plexus block in a semi-supine position and Combined anterior lumbar plexus and lateral sacral plexus block in a classical position. in people with Anesthesia, Local, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heyu Ji, MD (+8618374808445, jiheyu1929@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale Score (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05901415, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.