Spread of Paravertebral Injections in the Lumbar Plexus Area
|ClinicalTrials.gov Identifier: NCT03335462|
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : January 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lumbar Plexus Block||Other: Paravertebral injections Other: CT scan||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Spread of Paravertebral Injections in the Lumbar Plexus Area and Associated Risk Factors to Adjacent Organs: a CT Scan Based Report|
|Actual Study Start Date :||November 2, 2017|
|Actual Primary Completion Date :||December 30, 2017|
|Actual Study Completion Date :||December 30, 2017|
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
- Injection spread [ Time Frame: 5 minutes after the procedure ]Demonstrate spread of injected material in the lumbar plexus area according to different number of injections confirmed by CT guidance
- Distance between injections and kidney [ Time Frame: 5 minutes after the procedure ]Measure the distance between the injections and kidney to assess safety of the procedure
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335462
|Makassed General Hospital|
|Principal Investigator:||Zoher Naja, MD||Makassed General Hospital|