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

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: lumbar plexus block

• Registration Number: NCT04346758
• Lead Sponsor: Attikon Hospital

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-11-21
• Study Start: 2020-02-15
• Study First Submitted QC: 2020-04-11
• Study First Posted: 2020-04-15
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Modified Shamrock approach	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.

Primary Outcome Measures

Name	Time	Method
Time required to localize the lumbar plexus	10 minutes (from the begining of imaging procedure) (time in seconds to localize the 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)
Complications from lumbar plexus blockade	1 month	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.)

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	4 hours (visual analogue scale 0-10 at 4 hours postoperatively)	Postoperative pain relief 4 hours after completion of the block (visual analogue scale 0-10). A VAS score \<4 is considered adequate.

Trial Locations

Locations (1)

Attikon Hospital; 🇬🇷 Athens, Greece