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Completed

NCT Number: NCT06019754

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

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.

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Key information

Conditions

Lower Limb Fracture

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine - Zagazig University

Zagazig, 44519, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

one point combined Lumbar and sacral plexus block

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

Other names: No block intervention in control group

Primary outcomes

  1. Total intraoperative and postoperative opioid consumption

    Time frame: Total fentanyl used intraoperative and total morphine consumed up to 24 hours postoperative

    The total fentanyl doses consumed in the entire operative procedure and morphine consumed for 24 hours postoperative will be calculated.

Secondary outcomes

  1. (NRS) score assessment pre-block, 30 min post-block , and postoperatively in the recovery room, and then it will be repeated 3 h, 6h, 12h, and 24, hours

    Time frame: preoperative and postoperatively pain (NRS) score assessment for 24 hours

    Numerical Pain Score (NRS) ranges from 0 to 10, where 0 is no pain, and 10 is the worst pain imaginable. Adequate pain control will be considered at Numerical Pain Score (NRS) < 4.

    Pain will be assessed using (the NRS) score preoperatively before the block and 30 min post-block, then postoperatively in the recovery room, 3 h, 6h, 12h, and 24 hours.

  2. Block success assessment using perfusion index (PI) before and after performing the block

    Time frame: Recording Perfusion index readings at baseline and 10, 20, 30 min. post block

    Perfusion index (PI) values rise with successful peripheral nerve blocks. If PI is not changed, this means block failure

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

The One-Point Puncture Anterior Approach of the Combined Lumbar and Sacral Plexuses Block for Analgesia of Lower Limb Orthopedic Surgeries

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 31, 2023
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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