Liver Cancer, AdultBLOC-TAPNCT02527577
Analgesia by Transversus Abdominis Plane Nerve Block in Patients Undergoing Liver Resection.
A study testing RopivacaIne chlorhydrate in people with Liver Cancer, Adult, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The indications liver cancer surgery currently booming due to the increase in surgical techniques and instruments for a more secure resection of liver tissue with a significant reduction in bleeding or surgical complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Adult
- What is being tested?
- RopivacaIne chlorhydrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2010to Feb 2015
- 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
- hepatectomy or segmentectomy
Who cannot join
- Sepsis uncontrolled current
- Overdose in anticoagulant during general anesthesia
- Thrombocytopenia <50 g / dl
- Severe renal impairment: Cockcroft <30 ml / min
- history of ventricular arrhythmia serious unexplained .*
- Allergy to local anesthetics of the amide
- Contraindication to remifentanil and morphine
- Hypovolemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesia by Transversus Abdominis Plane Nerve Block in Patients Undergoing Liver Resection
The indications liver cancer surgery currently booming due to the increase in surgical techniques and instruments for a more secure resection of liver tissue with a significant reduction in bleeding or surgical complications. This allowed to expand surgical indications in the most fragile patients so assuming optimized anesthetic care.
So far, the technique of analgesia reference to this surgery remains administration of morphine analgesia via a device controlled by the patient (PCA) for epidural analgesia is against-indicated because of induced bleeding disorders by surgery.
Read more
Rafi then McDonnell in 2007 have described a new technique of loco regional anesthesia, the abdomen of the Transversus Abdominis Plane (TAP) nerve block(TAP), which allows selective anesthesia of the abdominal wall. But parietal pain related muscular and nervous sagging surgical approach represent a significant share of post operative pain.
This study proposes an evaluation of the abdomen transverse blocks in hepatectomy.
- Conditions
- Liver Cancer, Adult
- Being tested
- RopivacaIne chlorhydrate, Placebo
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaIne chlorhydrateDrug
Also called 3mg/kg
3mg/kg injection Hour (H) 0, H12 ; H24, H36 ; H48
PlaceboDrug
Also called NaCl 0,9%
injection Hour (H) 0, H12 ; H24, H36 ; H48
| Study group | Role | What they receive |
|---|---|---|
| ropivacaïne chlorhydrate monohydrate | Experimental | Not described Receives: Drug: RopivacaIne chlorhydrate |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
consumption of morphine over the first 48 hours postoperative.
Measured: at 48 hours postoperative
Secondary outcomes (1)
pharmacokinetic of ropivacaine (plasma concentrations)
Measured: 1, 2, 3, 6, 10, 24, 36, 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startApr 2010
- Primary completionSep 2014
- Study completionFeb 2015
Why it stopped: difficulties to recruit patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Cancer, AdultStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- carine.labruyere@chu-st-etienne.fr MOLLIEX, MD PhD, Principal investigator, CHU de SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527577
- Sponsor's protocol ID
- 0908127
- Other IDs
- 2009-017768-18, A100140-28, 2009
- Acronym
- BLOC-TAP
- Status last verified
- Jul 2015
- First submitted
- 14 Aug 2015
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia by Transversus Abdominis Plane Nerve Block in Patients Undergoing Liver Resection
- ClinicalTrials.gov ID
- NCT02527577
- Acronym / sponsor ID
- BLOC-TAP / 0908127
- Conditions
- Liver Cancer, Adult
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulties to recruit patients
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 19 Aug 2015 (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 indications liver cancer surgery currently booming due to the increase in surgical techniques and instruments for a more secure resection of liver tissue with a significant reduction in bleeding or surgical complications. This allowed to expand surgical indications in the most fragile patients so assuming optimized anesthetic care.
So far, the technique of analgesia reference to this surgery remains administration of morphine analgesia via a device controlled by the patient (PCA) for epidural analgesia is against-indicated because of induced bleeding disorders by surgery.
Rafi then McDonnell in 2007 have described a new technique of loco regional anesthesia, the abdomen of the Transversus Abdominis Plane (TAP) nerve block(TAP), which allows selective anesthesia of the abdominal wall. But parietal pain related muscular and nervous sagging surgical approach represent a significant share of post operative pain.
This study proposes an evaluation of the abdomen transverse blocks in hepatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ropivacaïne chlorhydrate monohydrate | Experimental | Drug: RopivacaIne chlorhydrate |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- hepatectomy or segmentectomy
Key exclusion criteria (8 listed)
- Sepsis uncontrolled current
- Overdose in anticoagulant during general anesthesia
- Thrombocytopenia <50 g / dl
- Severe renal impairment: Cockcroft <30 ml / min
- history of ventricular arrhythmia serious unexplained .*
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 |
|---|---|---|
| RopivacaIne chlorhydrateAlso: 3mg/kg3mg/kg injection Hour (H) 0, H12 ; H24, H36 ; H48 | Drug | ropivacaïne chlorhydrate monohydrate |
| PlaceboAlso: NaCl 0,9%injection Hour (H) 0, H12 ; H24, H36 ; H48 | Drug | placebo |
Primary outcome
consumption of morphine over the first 48 hours postoperative.
Time frame: at 48 hours postoperative
1 secondary outcome
pharmacokinetic of ropivacaine (plasma concentrations)
Time frame: 1, 2, 3, 6, 10, 24, 36, 48 hours post-dose
Results and safety
The study was stopped early (reason given: difficulties to recruit patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
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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.
carine.labruyere@chu-st-etienne.fr MOLLIEX, MD PhD principal investigator
CHU de SAINT-ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RopivacaIne chlorhydrate in people with Liver Cancer, Adult, run by Centre Hospitalier Universitaire de Saint Etienne 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 1 inclusion and 8 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 19 Aug 2015. 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: difficulties to recruit patients). 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?
consumption of morphine over the first 48 hours postoperative. (time frame: at 48 hours postoperative). 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 19 Aug 2015.