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Spread of Paravertebral Injections in the Lumbar Plexus Area

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335462
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Zoher Naja, Makassed General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Lumbar Plexus Block Other: Paravertebral injections Other: CT scan Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335462


Locations
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Lebanon
Makassed General Hospital
Beirut, Lebanon
Sponsors and Collaborators
Makassed General Hospital
Investigators
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Principal Investigator: Zoher Naja, MD Makassed General Hospital
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Responsible Party: Zoher Naja, Chairperson of Anesthesia and Pain Management Department, Makassed General Hospital
ClinicalTrials.gov Identifier: NCT03335462    
Other Study ID Numbers: 12112008
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No