Spread of Paravertebral Injections in the Lumbar Plexus Area

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

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Plexus Block
• Intervention / Treatment: Other: Paravertebral injections; Other: CT scan

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Makassed General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paravertebral injections; Lumbar paravertebral injections containing contrast will be performed. The needles are kept in their position and afterwards followed by CT scan.	Other: Paravertebral injections; Paravertebral injections will be performed in the thoraco-lumbar plexus area under CT guidance; Other: CT scan; CT scan will be performed as the needles are kept in their position after injecting the contrast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance between injections and kidney	Measure the distance between the injections and kidney to assess safety of the procedure	5 minutes after the procedure

Collaborators and Investigators

• Sponsor: Makassed General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2017
• Primary Completion (Actual): December 30, 2017
• Study Completion (Actual): December 30, 2017

Study Registration Dates

• First Submitted: October 31, 2017
• First Submitted That Met QC Criteria: November 4, 2017
• First Posted (Actual): November 7, 2017

Study Record Updates

• Last Update Posted (Actual): January 3, 2018
• Last Update Submitted That Met QC Criteria: January 2, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 12112008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No