Combined Lumbar and Sacral Branches Block Through the Ilio-Psoas Muscle Spaces for Analgesia of Lower Limb Surgeries

NCT ID: NCT06019754

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-10

Study Completion Date

2024-09-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

lumbosacral plexus block (LSPB) has been widely applied in orthopedics departments due to its advantages, including reduction in the application of opiates, decreasing the occurrence of acute pain, promoting early activation, and shortening the time of hospital stay. LSPB is a peripheral regional technique of anesthesia and analgesia, that provides a block of the main components of the lumbosacral plexus.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Traditional ultrasound-guided lumbar plexus block combined with sacral plexus block requires separate blocks at different sites, requiring the lateral decubitus or prone position, which may be suboptimal in patients with severe pain. we present an anterior approach for combined lumbar and sacral plexus blocks with a one-point puncture.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lower Limb Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Using a point puncture approach instead of two punctures to perform lumbosacral plexuses block in the interventional group.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors
Randomization assignments will be kept in sealed envelopes until all preprocedural measurements will be completed

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

patients who will be recruited in the control group will receive general anesthesia only

Group Type PLACEBO_COMPARATOR

one point combined Lumbar and sacral plexus block

Intervention Type PROCEDURE

performing an ultrasound-guided one-point combined Lumbar and sacral plexus block using a one-point puncture. Block success will be assessed using the perfusion index (PI) before and after performing the block

Interventional group

Patients who will be recruited in the Interventional will receive one point combined lumbar and sacral plexus block. then they will receive general anesthesia

Group Type ACTIVE_COMPARATOR

one point combined Lumbar and sacral plexus block

Intervention Type PROCEDURE

performing an ultrasound-guided one-point combined Lumbar and sacral plexus block using a one-point puncture. Block success will be assessed using the perfusion index (PI) before and after performing the block

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

one point combined Lumbar and sacral plexus block

performing an ultrasound-guided one-point combined Lumbar and sacral plexus block using a one-point puncture. Block success will be assessed using the perfusion index (PI) before and after performing the block

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

No block intervention in control group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ASA I-II.
* patients scheduled for unilateral femur or tibial surgery necessitate knee joint intervention
* patients who have severe pain hindering changing their position or patients who have spinal fractures or refusing spinal anesthesia.
* patients with the capability of communication

Exclusion Criteria

* puncture site infection
* patients with coagulation disorders
* patients who refuse to participate or withdraw due to personal reasons
* allergy to local anesthetics.
* past surgery at the site of the block
* hip ankylosis
* drug abuse
* Body mass index ≥ 35 kg/m2
* peripheral vascular insufficiency
* use of alpha or beta blocker agents
* Nerve injury or neuropathy of the affected lower limb
* cardiovascular or respiratory decompansation
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Naglaa Fathy Abdelhaleem Abdelhaleem

Lecturer, Anesthesia and Surgical Intensive Care department, Faculty of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Naglaa Abdelhaleem, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of medicine, Zagazig University Hospitals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Medicine - Zagazig University

Zagazig, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB#10892

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Motor Sparing Supraclavicular Block
NCT06074471 RECRUITING NA