Skip to main content
OpenTrials
Completed

NCT Number: NCT03335462

Spread of Paravertebral Injections in the Lumbar Plexus Area

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Makassed General Hospital

Beirut, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paravertebral injections

Other

Paravertebral injections will be performed in the thoraco-lumbar plexus area under CT guidance

CT scan

Other

CT scan will be performed as the needles are kept in their position after injecting the contrast

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Makassed General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 7, 2017
Registry last updated
Jan 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.