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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03335462
Enrollment
30
Registered
2017-11-07
Start date
2017-11-02
Completion date
2017-12-30
Last updated
2018-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Plexus Block

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.

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.

Interventions

OTHERParavertebral injections

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

OTHERCT scan

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

Sponsors

Makassed General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Injection spread5 minutes after the procedureDemonstrate spread of injected material in the lumbar plexus area according to different number of injections confirmed by CT guidance

Secondary

MeasureTime frameDescription
Distance between injections and kidney5 minutes after the procedureMeasure the distance between the injections and kidney to assess safety of the procedure

Countries

Lebanon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026