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

NCT06019754 | Completed

• 1 other identifier: IRB#10892
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Limb Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• (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

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

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

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

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Procedure: one point combined Lumbar and sacral plexus block

Interventional group

ACTIVE COMPARATOR

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

Interventions

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

Also known as: No block intervention in control group

Control group; Interventional group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of Medicine - Zagazig University

Zagazig, 44519, Egypt

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Naglaa Abdelhaleem, MD

  Faculty of medicine, Zagazig University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Randomization assignments will be kept in sealed envelopes until all preprocedural measurements will be completed
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Anesthesia and Surgical Intensive Care department, Faculty of Medicine

Model Details: Using a point puncture approach instead of two punctures to perform lumbosacral plexuses block in the interventional group.

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 31, 2023
• Study Start: September 10, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 4, 2024
• Last Updated: August 11, 2025

Record last verified: 2023-08

Locations

EG (1)