The Anterior Approach of the Combined Lumbar and Sacral Plexuses Block for Analgesia of Lower Limb Surgeries

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Lower Limb Fracture
• Intervention / Treatment: Procedure: one point combined Lumbar and sacral plexus block

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.

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Egypt, 44519
    • Faculty of Medicine - Zagazig University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ASA I-II.
• patients diagnosed with lower limb fracture by X-ray or CT examination necessitate intraoperative tourniquet application
• patients with any contraindications to spinal anesthesia
• patients who have severe pain hindering changing their position or patients who have spinal fractures
• 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
• drug abuse
• peripheral vascular insufficiency
• use of alpha or beta blocker agents
• Nerve injury of the affected lower limb

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; patients who will be recruited in the control group will receive general anesthesia only	Procedure: 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; Other Names: No block intervention in control group
Active Comparator: 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	Procedure: 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; Other Names: No block intervention in control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total intraoperative and postoperative opioid consumption	The total fentanyl doses consumed in the entire operative procedure and morphine consumed for 24 hours postoperative will be calculated.	Total fentanyl used intraoperative and total morphine consumed up to 24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(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	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.	preoperative and postoperatively pain (NRS) score assessment for 24 hours
Block success assessment using perfusion index (PI) before and after performing the block	Perfusion index (PI) values rise with successful peripheral nerve blocks. If PI is not changed, this means block failure	Recording Perfusion index readings at baseline and 10, 20, 30 min. post block

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Naglaa Abdelhaleem, MD, Faculty of medicine, Zagazig University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2023
• Primary Completion (Estimated): May 25, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: August 30, 2023
• First Posted (Actual): August 31, 2023

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 23, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: IRB#10892

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No