NCT03335462

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

November 2, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
Last Updated

January 3, 2018

Status Verified

January 1, 2018

Enrollment Period

2 months

First QC Date

October 31, 2017

Last Update Submit

January 2, 2018

Conditions

Lumbar Plexus Block

Outcome Measures

Primary Outcomes (1)

  • Injection spread

    Demonstrate spread of injected material in the lumbar plexus area according to different number of injections confirmed by CT guidance

    5 minutes after the procedure

Secondary Outcomes (1)

  • Distance between injections and kidney

    5 minutes after the procedure

Study Arms (1)

Paravertebral injections

EXPERIMENTAL

Lumbar paravertebral injections containing contrast will be performed. The needles are kept in their position and afterwards followed by CT scan.

Other: Paravertebral injectionsOther: CT scan

Interventions

Paravertebral injectionsOTHER

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

Paravertebral injections
CT scanOTHER

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

Paravertebral injections

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older than 18 years
  • Scheduled for hernia repair

You may not qualify if:

  • Patients
  • with coagulation disorders,
  • with infection at the injection site,
  • with allergy to contrast
  • receiving opioids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

Location

Study Officials

  • Zoher Naja, MD

    Makassed General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairperson of Anesthesia and Pain Management Department

Study Record Dates

First Submitted

October 31, 2017

First Posted

November 7, 2017

Study Start

November 2, 2017

Primary Completion

December 30, 2017

Study Completion

December 30, 2017

Last Updated

January 3, 2018

Record last verified: 2018-01

Locations

LE(1)