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

Lower Limb Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06019754
• Other study ID #: IRB#10892
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 10, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2024
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 56
• Est. completion date: June 1, 2024
• Est. primary completion date: May 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Lower Limb Fracture

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine - Zagazig University	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	(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
Secondary	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