Clinical Trials Directory

Trials / Completed

CompletedNCT03335462

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Makassed General Hospital · Academic / Other
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
OTHERParavertebral injectionsParavertebral injections will be performed in the thoraco-lumbar plexus area under CT guidance
OTHERCT scanCT scan will be performed as the needles are kept in their position after injecting the contrast

Timeline

Start date
2017-11-02
Primary completion
2017-12-30
Completion
2017-12-30
First posted
2017-11-07
Last updated
2018-01-03

Locations

1 site across 1 country: Lebanon

Source: ClinicalTrials.gov record NCT03335462. Inclusion in this directory is not an endorsement.