Spread of Paravertebral Injections in the Lumbar Plexus Area

Lumbar Plexus Block Clinical Trial

Official title:

The Spread of Paravertebral Injections in the Lumbar Plexus Area and Associated Risk Factors to Adjacent Organs: a CT Scan Based Report

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03335462
• Other study ID #: 12112008
• Status: Completed
• Phase: N/A
• First received: October 31, 2017
• Last updated: January 2, 2018
• Start date: November 2, 2017
• Est. completion date: December 30, 2017

Study information

• Verified date: January 2018
• Source: Makassed General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Lumbar paravertebral block (LPB) has been used for anesthesia in different settings such as in varicocelectomy and inguinal hernia repair in adults and pediatrics. Different studies considered LPB as an alternative to general and spinal anesthesia when contraindications exist, especially in elderly patients. However, the results obtained when using LPB are controversial in terms of number of injections performed and the success rates.

Description:

Patients scheduled for hernia repair who will agree to undergo different number of paravertebral injections in the thoraco-lumbar plexus area under CT guidance.

While the patient is in lateral decubitis position, LPB injections will be made using a 100 mm 22 G nerve stimulator needle (Stimuplex, B.Braun, Melsungen, Germany). The site of injection is determined by manual palpation. The number of injections ranges from one to five and the level of injections ranges from T11 to L3.

The needle is penetrated perpendicular to the skin using the following nerve stimulator settings: 5mA, 9V and 2Hz. The stimulating needle is gently manipulated into a position to allow an adequate muscular response with a stimulating current of 0.4-0.8 mA. At this point, 4-5 ml of the contrast (Telebrix 35, 350 mg/ml, Roissy CDG Cedex, France) is injected. The patients will receive the same amount of contrast, despite the different number of injections. The needles are kept in their position and afterwards followed by CT scan.

A radiologist who is blind to the study will interpret the radiological results and document the level at which the needle tip is found, the distance from the kidney and the spread of the injected contrast. In order to ensure patient's safety, different measures will be taken to keep the radiation as low as reasonably achievable.

Following the radiological practice, patients will be transferred to the operating room to undergo inguinal herniorrhaphy, and will not followed for the purpose of this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 30, 2017
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Older than 18 years

• Scheduled for hernia repair

Exclusion Criteria:

Patients

• with coagulation disorders,

• with infection at the injection site,

• with allergy to contrast

• receiving opioids

Related Conditions & MeSH terms

• Lumbar Plexus Block

Intervention

Other:
• Paravertebral injections
Paravertebral injections will be performed in the thoraco-lumbar plexus area under CT guidance
• CT scan
CT scan will be performed as the needles are kept in their position after injecting the contrast

Locations

Country	Name	City	State
Lebanon	Makassed General Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Makassed General Hospital

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Injection spread	Demonstrate spread of injected material in the lumbar plexus area according to different number of injections confirmed by CT guidance	5 minutes after the procedure
Secondary	Distance between injections and kidney	Measure the distance between the injections and kidney to assess safety of the procedure	5 minutes after the procedure