Ultrasound-assisted Shamrock Method for Lumbar Plexus Nerve Block in Elderly Trauma Patients, Revisited.

NCT04346758 | Completed

• 1 other identifier: AttikonH Shamrock 2019
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

A revised ultrasound-guided approach to the lumbar plexus is investigated as for efficacy and safety in elderly trauma patients undergoing operations of the lower extremeties.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• Time required to localize the lumbar plexus

  The time (in secondes) required of this modified Shamrock method to localize the lumbar plexus in the interpsoas compartment in elderly-trauma patients undergoing orthopedic procedures of the lower extremeties. Imaging time will be calculated (time to obtain appropriate imaging of the plexus) as well as needling time (time to obtain appropriate needle placement on the plexus)

  10 minutes (from the begining of imaging procedure) (time in seconds to localize the plexus)

• Complications from lumbar plexus blockade

  Safety of the modified Shamrock method of lumbar plexus blockade in elderly-trauma patients undergoing orthopedic procedures of the lower extremeties. All possible complications will be recorded (i.e. neurological complications, numbness, mobility disorder, haemmorhage, haematoma, e.t.c.)

  1 month

Secondary Outcomes (1)

• Postoperative pain

  4 hours (visual analogue scale 0-10 at 4 hours postoperatively)

Study Arms (1)

Modified Shamrock approach

OTHER

Patients undergoing orthopedic procedures of the lower extremeties are going to be studied. A modified Shamrock approach of the lumbar plexus is going to be used for postoperative analgesia, using an ultrasound-guided technique combined to a nerve stimulatior. The technique is going to be assessed as for accuracy, and safety.

Procedure: lumbar plexus block

Interventions

lumbar plexus block PROCEDURE

Patients undergoing orthopedic procedures of the lower extremeties are going to be studied. A modified Shamrock approach of the lumbar plexus is going to be used for postoperative analgesia, using an ultrasound-guided technique combined to a nerve stimulatior. The technique is going to be assessed as for accuracy, and safety.

Modified Shamrock approach

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients undergoing orthopedic trauma operations of the lower extremeties
• Age \>70 years old

You may not qualify if:

• Preexisting neuropathy of Lumbar plexus
• Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
• Allergy to local anaesthetics
• Prior surgery at the lumbar region

Sponsors & Collaborators

• Attikon Hospital: lead
• University of Athens: collaborator

Study Sites (1)

Attikon Hospital

Athens, Greece

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: April 15, 2020
• Study Start: February 15, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: December 8, 2020

Record last verified: 2020-12

Locations

GR (1)