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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04346758
• Other study ID #: AttikonH Shamrock 2019
• Status: Completed
• Phase: N/A
• Start date: February 15, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: December 2020
• Source: Attikon Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A modified ultrasound-guided Shamrock approach combined to nerve stimulation of the lumbar plexus is going to be investigated, in elderly trauma patients undergoing procedures of the lower extremities. The technique is going to be assessed as for its safety and its accuracy in localization of the plexus, by multiple measurements of the imaging time and needling time, In addition, efficacy and complications will be recorded and assessed during the immediate postoperative period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• lumbar plexus block
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.

Locations

Country	Name	City	State
Greece	Attikon Hospital	Athens

Sponsors (2)

Lead Sponsor	Collaborator
Attikon Hospital	University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Postoperative pain	Postoperative pain relief 4 hours after completion of the block (visual analogue scale 0-10). A VAS score <4 is considered adequate.	4 hours (visual analogue scale 0-10 at 4 hours postoperatively)