Breast Cancer PatientsNCT07064317
Catheter Tip Position and Contrast Distribution Following Paravertebral Catheter Insertion: a CT Study
An observational study of Breast Cancer Patients, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial summary
This retrospective study aims to assess the impact of paravertebral catheter insertion depth on the final anatomical position of the catheter tip. Another objective is to characterize the contrast distribution patterns through paravertebral catheters verified to reside within the thoracic paravertebral space. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer Patients
- How many people
- 31 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Jan 2010to 25 Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who received a paravertebral catheter at Clinique Sainte-Anne Saint Rémi, Brussels, Belgium, between January 2010 and January 2012.
Who may be able to join
- Breast surgery patients who received a paravertebral catheter at Clinique Sainte-Anne Saint Rémi, Brussels, Belgium, between January 2010 and January 2012
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
This retrospective study aims to assess the impact of paravertebral catheter insertion depth on the final anatomical position of the catheter tip. Another objective is to characterize the contrast distribution patterns through paravertebral catheters verified to reside within the thoracic paravertebral space.
Read the detailed description
The effectiveness of a continuous thoracic paravertebral block depends on optimal catheter tip placement and adequate distribution of local anesthetic. This study evaluated the relation between the catheter insertion depth and the final anatomical position of the catheter tip. Additionally, contrast distribution patterns were assessed for catheter tips residing within the thoracic paravertebral space.
Ultrasound-guided paravertebral catheters were inserted at multiple catheter insertion depths beyond the needle tip in 31 patients undergoing breast surgery. Post-mobilization computed tomography (CT) imaging was used to determine the catheter tip location. Catheter tips with a confirmed position in the paravertebral space were further analyzed for contrast distribution.
- Conditions
- Breast Cancer Patients
- Keywords
- Thoracic paravertebral catheter, Ultrasound-guided paravertebral block, Catheter depth, Breast cancer patient, CT imaging, Catheter tip position, Mobilization, Contrast distribution, Spread
What is being measured
The primary outcome is the main question the study is designed to answer.
Paravertebral catheter tip position
Postoperatively, patients underwent CT scanning with 0.1 mL of contrast dye (Iomeron, iomeprol, Bracco) to precisely determine the catheter tip position and permit adjustments if needed. Two anesthesiologists independently evaluated the CT images with regards to the insertion level, depth relative to the lamina, and catheter tip location in relation to key anatomical structures. Tip locations were defined as paravertebral or non-paravertebral. Different locations were identified for both the paravertebral and the non-paravertebral spaces.
Paravertebral space locations:
Anterior paravertebral: Between the anterior and posterior borders of the vertebral corpus.
Periforaminal paravertebral: Within 1 cm of the foramen. Posterior paravertebral: From the foramen to the articular process.
Non-paravertebral locations:
Prevertebral: Anterior to the vertebral body. Intramuscular: Posterior to the lamina within the erector spinae muscles. Epidural and Pleural: Standard anatomical definition.
Measured: 1 Day of breast surgery
Secondary outcomes (1)
Paravertebral contrast distribution
Postoperatively, patients received a CT scan with 0.1 mL of contrast dye (Iomeron, iomeprol, Bracco) to evaluate the catheter tip position. Only patients with a catheter in the paravertebral space received a second bolus of 1 mL contrast dye and 9 mL saline 0.9%. Two anesthesiologists independently evaluated the catheter tip position across the different anatomical areas close to the paravertebral space. Additionally, the contrast distribution was assessed in the anteroposterior and craniocaudal direction of catheters with a paravertebral catheter tip position.
Paravertebral space locations:
Anterior paravertebral: Between the anterior and posterior borders of the vertebral corpus.
Posterior paravertebral: From the foramen to the articular process.
Non-paravertebral locations:
Prevertebral: Anterior to the vertebral body. Intramuscular: Posterior to the lamina within the erector spinae muscles. Epidural, Intercostal and Pleural: Standard anatomical definitions applied.
Measured: 1 Day of breast surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start27 Jan 2010
- Primary completion25 Jan 2012
- Study completion25 Jan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Collaborators
- Chirec
- Responsible party
- Principal investigator, Imré Van Herreweghe, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064317
- Sponsor's protocol ID
- 2024/326
- Status last verified
- Jul 2025
- First submitted
- 26 Jun 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter Tip Position and Contrast Distribution Following Paravertebral Catheter Insertion: a CT Study
- ClinicalTrials.gov ID
- NCT07064317
- Acronym / sponsor ID
- 2024/326
- Conditions
- Breast Cancer Patients
- Keywords
- Thoracic paravertebral catheter, Ultrasound-guided paravertebral block, Catheter depth, Breast cancer patient, CT imaging, Catheter tip position, Mobilization, Contrast distribution
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Collaborators
- Chirec
- Study start
- 27 Jan 2010 (actual)
- Primary completion
- 25 Jan 2012 (actual)
- Study completion
- 25 Jan 2012 (actual)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective study aims to assess the impact of paravertebral catheter insertion depth on the final anatomical position of the catheter tip. Another objective is to characterize the contrast distribution patterns through paravertebral catheters verified to reside within the thoracic paravertebral space.
Detailed description
The effectiveness of a continuous thoracic paravertebral block depends on optimal catheter tip placement and adequate distribution of local anesthetic. This study evaluated the relation between the catheter insertion depth and the final anatomical position of the catheter tip. Additionally, contrast distribution patterns were assessed for catheter tips residing within the thoracic paravertebral space.
Ultrasound-guided paravertebral catheters were inserted at multiple catheter insertion depths beyond the needle tip in 31 patients undergoing breast surgery. Post-mobilization computed tomography (CT) imaging was used to determine the catheter tip location. Catheter tips with a confirmed position in the paravertebral space were further analyzed for contrast distribution.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who received a paravertebral catheter at Clinique Sainte-Anne Saint Rémi, Brussels, Belgium, between January 2010 and January 2012.
Key inclusion criteria (1 listed)
- Breast surgery patients who received a paravertebral catheter at Clinique Sainte-Anne Saint Rémi, Brussels, Belgium, between January 2010 and January 2012
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Paravertebral catheter tip position
Time frame: 1 Day of breast surgery
Postoperatively, patients underwent CT scanning with 0.1 mL of contrast dye (Iomeron, iomeprol, Bracco) to precisely determine the catheter tip position and permit adjustments if needed. Two anesthesiologists independently evaluated the CT images with regards to the insertion level, depth relative to the lamina, and catheter tip location in relation to key anatomical structures. Tip locations were defined as paravertebral or non-paravertebral. Different locations were identified for both the paravertebral and the non-paravertebral spaces. Paravertebral space locations: Anterior paravertebral: Between the anterior and posterior borders of the vertebral corpus. Periforaminal paravertebral: Within 1 cm of the foramen. Posterior paravertebral: From the foramen to the articular process. Non-paravertebral locations: Prevertebral: Anterior to the vertebral body. Intramuscular: Posterior to the lamina within the erector spinae muscles. Epidural and Pleural: Standard anatomical definition.
1 secondary outcome
Paravertebral contrast distribution
Time frame: 1 Day of breast surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Patients, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paravertebral catheter tip position (time frame: 1 Day of breast surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.