Thoracotomy SurgeryPhase 2BPV échoguidéNCT01842698
Ultrasound-guided PVB
A Phase 2 study testing ultrasoundguided paravertebral catheter in people with Thoracotomy Surgery and Anesthesia, run by Centre Jean Perrin at 1 site in France.
Trial summary
Thoracotomy, is a surgical procedure performed routinely in connection with pulmonary surgery. Pain induced by thoracotomy is considered as the most severe post-operative pain. Control of the pain is essential in the perioperative management. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thoracotomy Surgery, Anesthesia, Ultrasound-guided PVB
- What is being tested?
- ultrasoundguided paravertebral catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to Dec 2013
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing programmed lateral or posterolateral thoracotomy, regardless of indication,
- Aged 18 to 80 years
Who cannot join
- Surgery performed in the emergency;
- Specific clinical contexts including neoplasia in terminal phase or palliative phase;
- Contraindications to the products of the study
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de lautte contre le cancer - Centre Jean Perrin
Clermont-Ferrand, 63000
About this study
Official title: Feasibility of the Use of Ultrasound-guided Paravertebral Catheterisation for the Analgesic Management of Thoracotomy
Thoracotomy, is a surgical procedure performed routinely in connection with pulmonary surgery. Pain induced by thoracotomy is considered as the most severe post-operative pain. Control of the pain is essential in the perioperative management.
Nowadays, there are several strategies to support this pain, including regional anesthesia techniques in the context of multimodal analgesia. Epidural analgesia reduces pain scores and respiratory complications significantly. ParaVertebral Block (PVB) is a technique as effective as epidural analgesia in the treatment of pain after thoracotomy and could present a more limited number of complications. However, there is no consensus on the best technique for realisation of PVB.
Read more
Para-vertebral catheterisation can be performed by posterior approach in seeking a strength loss after bone contact of transverse vertebral process using the technique of Eason and Wyatt, but it is a blind technique. The ultrasonographic control, developed in the context of all puncture invasive actions, is an effective contribution to the realisation of a BPV, but still insufficiently validated. First used to measure the distance skin - posterior costo-transverse ligament and skin - parietal pleura before procedure, the ultrasonography has recently led to the publication of echo-guided techniques combining recognition of structures defining the space para- vertebral, viewing the progression of the needle and the spread of the local anesthetic. The handling of the ultrasonographic probe associated with the puncture requires additional learning.
The objective of this project is to study the feasibility of para-vertebral catheter insertion under ultrasonographic control. The appearance like "pigtail" of the catheter, the most recently proposed, seems the more attractive in terms of safety. The aim of this pilot prospective study is accurately quantify all qualitative parameters related to the technique in order to achieve a future validation with a medico-economic component.
Ultrasound-guided technique will correspond to a technique with a puncture of the lateral to medial space described by Shibata, after spotting of the first rib proposed by Bouzinac.
This study will be proposed to patients undergoing thoracotomy for total or partial pulmonary resection in Thoracic Surgery service of Centre Jean Perrin, the number of patients required is 60 patients over a period of inclusion of 12 months.
Read the detailed description
Prospective followed of cohort including consecutive patients, all receiving the same technique of anesthesia and analgesia:
- Preoperative para-vertebral catheterisation on the surgery side.
- Preoperative test of the efficiency of para-vertebral block.
- Conventional general anesthesia.
- Conventional rescue postoperative analgesia.
- Systematic radiographic control with injection of contrast product into the para-vertebral catheter.
- Conventional postoperative monitoring.
- Being tested
- ultrasoundguided paravertebral catheter
- Keywords
- Thoracotomy surgery, Anesthesia, Ultrasound-guided PVB, Post-operative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundguided paravertebral catheterDevice
Also called ultrasound-guided paravertebral catheterisation
| Study group | Role | What they receive |
|---|---|---|
| ultrasoundguided paravertebral catheter | Experimental | ultrasoundguided paravertebral catheter Receives: Device: ultrasoundguided paravertebral catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall failure rate of the para-vertebral block
The overall failure rate of the para-vertebral block ( failed installation or efficiency)
Measured: 24 hours
Secondary outcomes (5)
The time (in minutes) between the start of the installation and the effective para-vertebral block obtaining
Effective para-vertebral block obtaining
Measured: 24 hours
Paravertebral block catheterisation
•Paravertebral catheterisation efficiency
Measured: 24 hours
Paravertebral block efficiency
Paravertebral block efficiency
Measured: 24 hours
Pain evaluation
•Pain evaluation with Analogic Visual Scale
Measured: H0+30 min, +1h, +1h30, +2h, +4h, +8h, +12h, +16h, +20h, +24h, +32h, +40h, +48h
Tolerance hemodynamic, nausea and vomiting
Tolerance hemodynamic, nausea and vomiting reporting
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: The study was stopped because there was a technical problem with the ultrasound used in the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracotomy SurgeryStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hammou TAHERI, PhD, Principal investigator, Centre de lutte contre le cancer - Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842698
- Sponsor's protocol ID
- BPVéchoguidé
- Acronym
- BPV échoguidé
- Status last verified
- Mar 2014
- First submitted
- 14 Feb 2013
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the Use of Ultrasound-guided Paravertebral Catheterisation for the Analgesic Management of Thoracotomy
- ClinicalTrials.gov ID
- NCT01842698
- Acronym / sponsor ID
- BPV échoguidé / BPVéchoguidé
- Keywords
- Thoracotomy surgery, Anesthesia, Ultrasound-guided PVB, Post-operative pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped because there was a technical problem with the ultrasound used in the trial.
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Apr 2013 (estimated)
- 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.
Thoracotomy, is a surgical procedure performed routinely in connection with pulmonary surgery. Pain induced by thoracotomy is considered as the most severe post-operative pain. Control of the pain is essential in the perioperative management.
Nowadays, there are several strategies to support this pain, including regional anesthesia techniques in the context of multimodal analgesia. Epidural analgesia reduces pain scores and respiratory complications significantly. ParaVertebral Block (PVB) is a technique as effective as epidural analgesia in the treatment of pain after thoracotomy and could present a more limited number of complications. However, there is no consensus on the best technique for realisation of PVB.
Para-vertebral catheterisation can be performed by posterior approach in seeking a strength loss after bone contact of transverse vertebral process using the technique of Eason and Wyatt, but it is a blind technique. The ultrasonographic control, developed in the context of all puncture invasive actions, is an effective contribution to the realisation of a BPV, but still insufficiently validated. First used to measure the distance skin - posterior costo-transverse ligament and skin - parietal pleura before procedure, the ultrasonography has recently led to the publication of echo-guided techniques combining recognition of structures defining the space para- vertebral, viewing the progression of the needle and the spread of the local anesthetic. The handling of the ultrasonographic probe associated with the puncture requires additional learning.
The objective of this project is to study the feasibility of para-vertebral catheter insertion under ultrasonographic control. The appearance like "pigtail" of the catheter, the most recently proposed, seems the more attractive in terms of safety. The aim of this pilot prospective study is accurately quantify all qualitative parameters related to the technique in order to achieve a future validation with a medico-economic component.
Ultrasound-guided technique will correspond to a technique with a puncture of the lateral to medial space described by Shibata, after spotting of the first rib proposed by Bouzinac.
This study will be proposed to patients undergoing thoracotomy for total or partial pulmonary resection in Thoracic Surgery service of Centre Jean Perrin, the number of patients required is 60 patients over a period of inclusion of 12 months.
Detailed description
Prospective followed of cohort including consecutive patients, all receiving the same technique of anesthesia and analgesia:
- Preoperative para-vertebral catheterisation on the surgery side.
- Preoperative test of the efficiency of para-vertebral block.
- Conventional general anesthesia.
- Conventional rescue postoperative analgesia.
- Systematic radiographic control with injection of contrast product into the para-vertebral catheter.
- Conventional postoperative monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultrasoundguided paravertebral catheter | Experimental | Device: ultrasoundguided paravertebral catheterultrasoundguided paravertebral catheter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing programmed lateral or posterolateral thoracotomy, regardless of indication,
- Aged 18 to 80 years
Key exclusion criteria (3 listed)
- Surgery performed in the emergency;
- Specific clinical contexts including neoplasia in terminal phase or palliative phase;
- Contraindications to the products of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasoundguided paravertebral catheterAlso: ultrasound-guided paravertebral catheterisation | Device | ultrasoundguided paravertebral catheter |
Primary outcome
The overall failure rate of the para-vertebral block
Time frame: 24 hours
The overall failure rate of the para-vertebral block ( failed installation or efficiency)
5 secondary outcomes
The time (in minutes) between the start of the installation and the effective para-vertebral block obtaining
Time frame: 24 hours
Paravertebral block catheterisation
Time frame: 24 hours
Paravertebral block efficiency
Time frame: 24 hours
Pain evaluation
Time frame: H0+30 min, +1h, +1h30, +2h, +4h, +8h, +12h, +16h, +20h, +24h, +32h, +40h, +48h
Tolerance hemodynamic, nausea and vomiting
Time frame: 72 hours
Results and safety
The study was stopped early (reason given: The study was stopped because there was a technical problem with the ultrasound used in the trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2014.
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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.
Hammou TAHERI, PhD principal investigator
Centre de lutte contre le cancer - Centre Jean Perrin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ultrasoundguided paravertebral catheter in people with Thoracotomy Surgery and Anesthesia, run by Centre Jean Perrin at 1 site in France.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 20 Mar 2014. 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was stopped because there was a technical problem with the ultrasound used in the trial.). Results are not available in the source record.
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?
The overall failure rate of the para-vertebral block (time frame: 24 hours). 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 20 Mar 2014.