Indication for Renal and/or Adrenal SurgeryBPVNCT01023854
Merits of Continuous Paravertebral Block in the Management of Renal/Adrenal Surgery by Laparotomy
A study testing Continuous Paravertebral block in people with Indication for Renal and/or Adrenal Surgery, run by University Hospital, Brest at 1 site in France.
Trial summary
The paravertebral block is an alternative in the analgesia epidural the major interest of which lives in the catheterisation of the paravertébral space allowing to assure/insure an one-sided continuous analgesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Indication for Renal and/or Adrenal Surgery
- What is being tested?
- Continuous Paravertebral block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2009to Sep 2013
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Patient scheduled for renal and/or adrenal surgery
- American Society of Anesthesiologists score ASA I, II, III
- Written informed consent given by the patient
Who cannot join
- Contraindication in the loco-regional anesthesia in the products of local anesthetic
- Surgery as a matter of urgency
- Pregnancy
- Congestive Cardiac insufficiency
- Severe hepatic Incapacity
- Disturbs of the coagulation
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- Age < 18 years
- ASA IV
- Patient already participating in a study or deadline 3-month-old subordinate since the end of a previous study
- Under guardianship Patient
- Psychiatric pathology or limitation of the intellectual abilities making difficult the understanding of the subjective questions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Consideration of the Merits of Continuous Paravertebral Block in the Management of Renal and/or Adrenal Surgery by Laparotomy in Adults
The paravertebral block is an alternative in the analgesia epidural the major interest of which lives in the catheterisation of the paravertébral space allowing to assure/insure an one-sided continuous analgesia.
The main objective of the study is to bring to light the superiority of the continuous paravertébral block, as a supplement to analgesia, in the care of the renal and\or adrenal surgery by laparotomy at the adult in terms of consumption of morphine, with regard to the classic analgesia classic.
The main assessment criterion is the consumption of morphine within first 24 postoperative hours at the patients benefiting from a paravertébral continuous block besides the classic systematic analgesia.
- Being tested
- Continuous Paravertebral block
- Keywords
- Paravertebral block, loco regional anesthesia, renal surgery, PCA morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Paravertebral blockProcedure or surgery
The paravertébral block is a peripheral block which gets an one-sided continuous analgesia by infiltration of the spinal nerves which appear from the intervertebral foramen.
Its realization consists of a draining in 2-3 cm of the thorny apophyses ( T6-T8). During the perception of the osseous contact (cross-functional process of the vertebra), the needle is redirected in cephalic direction until a loss of resistance corresponding to the passage of the upper costo-cross-functional ligament that is in the entrance to the paravertébral space. A catheter is then inserted into the paravertébral space.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Paravertebral block | Experimental | Continuous Paravertebral block Receives: Procedure: Continuous Paravertebral block |
| Placebo | Placebo comparator | Placebo Receives: Procedure: Continuous Paravertebral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption during the first 24 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2012
- Study completionSep 2013
Why it stopped: No more potentiel patients for study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indication for Renal and/or Adrenal SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François LION, Doctor, Principal investigator, Brest, Hospital University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023854
- Sponsor's protocol ID
- BPV
- Other IDs
- RB 09.011
- Acronym
- BPV
- Status last verified
- Jul 2014
- First submitted
- 1 Dec 2009
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consideration of the Merits of Continuous Paravertebral Block in the Management of Renal and/or Adrenal Surgery by Laparotomy in Adults
- ClinicalTrials.gov ID
- NCT01023854
- Acronym / sponsor ID
- BPV / BPV
- Keywords
- Paravertebral block, loco regional anesthesia, renal surgery, PCA morphine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No more potentiel patients for study
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 2 Dec 2009 (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.
The paravertebral block is an alternative in the analgesia epidural the major interest of which lives in the catheterisation of the paravertébral space allowing to assure/insure an one-sided continuous analgesia.
The main objective of the study is to bring to light the superiority of the continuous paravertébral block, as a supplement to analgesia, in the care of the renal and\or adrenal surgery by laparotomy at the adult in terms of consumption of morphine, with regard to the classic analgesia classic.
The main assessment criterion is the consumption of morphine within first 24 postoperative hours at the patients benefiting from a paravertébral continuous block besides the classic systematic analgesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Paravertebral block | Experimental | Procedure: Continuous Paravertebral blockContinuous Paravertebral block |
| Placebo | Placebo comparator | Procedure: Continuous Paravertebral blockPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Patient scheduled for renal and/or adrenal surgery
- American Society of Anesthesiologists score ASA I, II, III
- Written informed consent given by the patient
Key exclusion criteria (11 listed)
- Contraindication in the loco-regional anesthesia in the products of local anesthetic
- Surgery as a matter of urgency
- Pregnancy
- Congestive Cardiac insufficiency
- Severe hepatic Incapacity
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 |
|---|---|---|
| Continuous Paravertebral blockThe paravertébral block is a peripheral block which gets an one-sided continuous analgesia by infiltration of the spinal nerves which appear from the intervertebral foramen. Its realization consists of a draining in 2-3 cm of the thorny apophyses ( T6-T8). During the perception of the osseous contact (cross-functional process of the vertebra), the needle is redirected in cephalic direction until a loss of resistance corresponding to the passage of the upper costo-cross-functional ligament that is in the entrance to the paravertébral space. A catheter is then inserted into the paravertébral space. | Procedure or surgery | Continuous Paravertebral block, Placebo |
Primary outcome
morphine consumption during the first 24 hours
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: No more potentiel patients for study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2014.
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.
François LION, Doctor principal investigator
Brest, Hospital University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Paravertebral block in people with Indication for Renal and/or Adrenal Surgery, run by University Hospital, Brest 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 4 inclusion and 11 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 30 Jul 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: No more potentiel patients for study). 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?
morphine consumption during the first 24 hours (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 30 Jul 2014.