Clinical trial NCT06019754: The Anterior Approach of the Combined Lumbar and Sacral Plexuses Block for Analgesia of Lower Limb Surgeries
Official title: The One-Point Puncture Anterior Approach of the Combined Lumbar and Sacral Plexuses Block for Analgesia of Lower Limb Orthopedic Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Limb Fracture
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2023-08-31
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Using a point puncture approach instead of two punctures to perform lumbosacral plexuses block in the interventional group.
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total intraoperative and postoperative opioid consumption
timeFrame: Total fentanyl used intraoperative and total morphine consumed up to 24 hours postoperative
Secondary outcomes:
measure: (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
timeFrame: preoperative and postoperatively pain (NRS) score assessment for 24 hours
measure: Block success assessment using perfusion index (PI) before and after performing the block
timeFrame: Recording Perfusion index readings at baseline and 10, 20, 30 min. post block
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Medicine - Zagazig University
Study officials:
affiliation: Faculty of medicine, Zagazig University Hospitals
name: Naglaa Abdelhaleem, MD
role: PRINCIPAL_INVESTIGATOR
References: