HepatectomyPhase 3CATPARNCT02353702
Efficacy of Local Anesthesic on Diaphragmatic Function After Upper Abdominal Surgery
A Phase 3 study testing Sniff test, Infusion of Ropivacaine during 48 hours and Continuous parietal infusion with parietal catheter in people with Hepatectomy, run by University Hospital, Rouen at 1 site in France.
Trial summary
Upper abdominal surgery is known to induce such pulmonary complications as pneumonia, atelectasis, pleural effusion. The post operative diaphragmatic dysfunction participates to these complications and lasts for 7 days after upper abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatectomy
- What is being tested?
- Sniff test, Infusion of Ropivacaine during 48 hours and Continuous parietal infusion with parietal catheter
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2014to Jun 2017
- Phase
- Phase 3
- 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
- Surgical Indication for Upper abdominal surgery through subcostal incision
- More than 18 years old , less than 80 years old
- ASA score between 1 and 3
- Effective contraception for more than 3 months in women of childbearing age
- Patients signed an informed consent
- Affiliation to a social security regimen
Who cannot join
- BMI more than 30 kg/m2
- Nasal obstruction during inclusion
- Preoperative treatment with morphine
- Need for a postoperative nasogastric tube
- Difficulty to understand the use of the PCA and/or the sniff-test
- Impossibility to place the catheter in preperitoneal position
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- Pregnant women or breasting women
- Patients under guardianship
- Contraindication to use of ropivacaine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Parietal Continuous Infiltration of Local Anesthesic on Diaphragmatic Function After Upper Abdominal Surgery Through a Subcostal Incision
Upper abdominal surgery is known to induce such pulmonary complications as pneumonia, atelectasis, pleural effusion. The post operative diaphragmatic dysfunction participates to these complications and lasts for 7 days after upper abdominal surgery. The sniff-test is a recognized tool for measuring the diaphragmatic function.The purpose of this study is to evaluate the effectiveness of parietal analgesia with continuous infiltration of local anesthesic on diaphragmatic function after upper abdominal surgery through a subcostal incision. Our main outcome is to measure the diaphragmatic function with the sniff test in 44 patients with parietal infiltration of ropivacaine and in 44 patients with placebo. Our secondary outcomes are the evaluation of the effect of continuous parietal analgesia with ropivacaine on IPmax and EPmax, oxygen saturation, post operative pulmonary complications and post operative recovery. This prospective study will determine if the pre peritoneal local infiltration of ropivacaine is useful to decrease post operative diaphragmatic dysfunction.
- Conditions
- Hepatectomy
- Being tested
- Sniff test, Infusion of Ropivacaine during 48 hours, Continuous parietal infusion with parietal catheter, Infusion of placebo during 48 hours, NaCl
- Keywords
- Diaphragmatic function, sniff-test, pulmonary complications, upper abdominal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sniff testProcedure or surgery
Evaluation of diaphragmatic function by sniff test after continuous parietal infusion of ropivacaine or placebo
Infusion of Ropivacaine during 48 hoursDrug
20 ml Bolus (7,5 mg/ml) then continuous administration of 10 ml per hour (2 mg/ml) during 48 hours of Ropivacaine.
20 ml Bolus (NaCl 0.9 %) then continuous administration of 10 ml per hour, during 48 hours of NaCl 0.9 %.
Continuous parietal infusion with parietal catheterDevice
Continuous parietal infiltration of Ropivacaine or placebo
Infusion of placebo during 48 hoursDrug
NaClDrug
| Study group | Role | What they receive |
|---|---|---|
| Infusion of Ropivacaine during 48 hours | Experimental | Evaluation of diaphragmatic function with Sniff test after 48h continuous parietal infiltration of Ropivacaine using parietal catheter at the following dose :
20 ml Bolus (7,5 mg/ml) then continuous administration of 10 ml per hour (2 mg/ml) Receives: Procedure: Sniff test; Drug: Infusion of Ropivacaine during 48 hours; Device: Continuous parietal infusion with parietal catheter; Drug: NaCl |
| Infusion of placebo during 48 hours | Placebo comparator | Evaluation of diaphragmatic function with Sniff test after 48h continuous parietal infiltration of placebo using parietal catheter at the following dose :
20 ml Bolus (NaCl 0.9 %) then continuous administration of 10 ml per hour (NaCl 0.9 %) Receives: Procedure: Sniff test; Device: Continuous parietal infusion with parietal catheter; Drug: Infusion of placebo during 48 hours; Drug: NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Buccal Inspiratory Pression (IP) Evaluation of diaphragmatic function using sniff test.
Evaluation of diaphragmatic function using sniff test. The measured value is buccal inspiratory pression.
Measured: Day 6 post surgery
Secondary outcomes (7)
Maximal buccal inspiratory pression (IPmax) using sniff test
Evaluation of maximal buccal inspiratory pression (IPmax) using sniff test
Measured: Day 6 after surgical procedure
Maximal buccal expiratory pression (EPmax) using sniff test
Evaluation of maximal buccal expiratory pression (EPmax) using sniff test
Measured: Day 6 after surgical procedure
Oxygen saturation rate
Evaluation of Oxygen saturation
Measured: Day 6 after surgical procedure
medical complication outcome (pneumonia)
Medical pulmonary complications outcome : pneumonia
Measured: week 6 after surgical procedure
medical complication outcome (atelectasis)
Medical pulmonary complications outcome : atelectasis
Measured: week 6 after surgical procedure
medical complication outcome (pleural effusions)
Medical pulmonary complications outcome : pleural effusions
Measured: week 6 after surgical procedure
Morphine consummation (Measurement of Morphine consummation since surgery)
Measured: week 6 after surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startJul 2014
- Primary completionJun 2017
- Study completionJun 2017
Why it stopped: End of enrollment period, difficulty enrolling patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatectomyStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel SCOTTE, Pr, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353702
- Sponsor's protocol ID
- 2012/176/HP
- Acronym
- CATPAR
- Status last verified
- Aug 2017
- First submitted
- 22 Jan 2015
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Parietal Continuous Infiltration of Local Anesthesic on Diaphragmatic Function After Upper Abdominal Surgery Through a Subcostal Incision
- ClinicalTrials.gov ID
- NCT02353702
- Acronym / sponsor ID
- CATPAR / 2012/176/HP
- Conditions
- Hepatectomy
- Keywords
- Diaphragmatic function, sniff-test, pulmonary complications, upper abdominal surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End of enrollment period, difficulty enrolling patients
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 3 Feb 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.
Upper abdominal surgery is known to induce such pulmonary complications as pneumonia, atelectasis, pleural effusion. The post operative diaphragmatic dysfunction participates to these complications and lasts for 7 days after upper abdominal surgery. The sniff-test is a recognized tool for measuring the diaphragmatic function.The purpose of this study is to evaluate the effectiveness of parietal analgesia with continuous infiltration of local anesthesic on diaphragmatic function after upper abdominal surgery through a subcostal incision. Our main outcome is to measure the diaphragmatic function with the sniff test in 44 patients with parietal infiltration of ropivacaine and in 44 patients with placebo. Our secondary outcomes are the evaluation of the effect of continuous parietal analgesia with ropivacaine on IPmax and EPmax, oxygen saturation, post operative pulmonary complications and post operative recovery. This prospective study will determine if the pre peritoneal local infiltration of ropivacaine is useful to decrease post operative diaphragmatic dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infusion of Ropivacaine during 48 hours | Experimental | Procedure: Sniff test, Drug: Infusion of Ropivacaine during 48 hours, Device: Continuous parietal infusion with parietal catheter, Drug: NaClEvaluation of diaphragmatic function with Sniff test after 48h continuous parietal infiltration of Ropivacaine using parietal catheter at the following dose : 20 ml Bolus (7,5 mg/ml) then continuous administration of 10 ml per hour (2 mg/ml) |
| Infusion of placebo during 48 hours | Placebo comparator | Procedure: Sniff test, Device: Continuous parietal infusion with parietal catheter, Drug: Infusion of placebo during 48 hours, Drug: NaClEvaluation of diaphragmatic function with Sniff test after 48h continuous parietal infiltration of placebo using parietal catheter at the following dose : 20 ml Bolus (NaCl 0.9 %) then continuous administration of 10 ml per hour (NaCl 0.9 %) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Surgical Indication for Upper abdominal surgery through subcostal incision
- More than 18 years old , less than 80 years old
- ASA score between 1 and 3
- Effective contraception for more than 3 months in women of childbearing age
- Patients signed an informed consent
Key exclusion criteria (9 listed)
- BMI more than 30 kg/m2
- Nasal obstruction during inclusion
- Preoperative treatment with morphine
- Need for a postoperative nasogastric tube
- Difficulty to understand the use of the PCA and/or the sniff-test
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 |
|---|---|---|
| Sniff testEvaluation of diaphragmatic function by sniff test after continuous parietal infusion of ropivacaine or placebo | Procedure or surgery | Infusion of Ropivacaine during 48 hours, Infusion of placebo during 48 hours |
| Infusion of Ropivacaine during 48 hours20 ml Bolus (7,5 mg/ml) then continuous administration of 10 ml per hour (2 mg/ml) during 48 hours of Ropivacaine. 20 ml Bolus (NaCl 0.9 %) then continuous administration of 10 ml per hour, during 48 hours of NaCl 0.9 %. | Drug | Infusion of Ropivacaine during 48 hours |
| Continuous parietal infusion with parietal catheterContinuous parietal infiltration of Ropivacaine or placebo | Device | Infusion of Ropivacaine during 48 hours, Infusion of placebo during 48 hours |
| Infusion of placebo during 48 hours | Drug | Infusion of placebo during 48 hours |
| NaCl | Drug | Infusion of Ropivacaine during 48 hours, Infusion of placebo during 48 hours |
Primary outcome
Buccal Inspiratory Pression (IP) Evaluation of diaphragmatic function using sniff test.
Time frame: Day 6 post surgery
Evaluation of diaphragmatic function using sniff test. The measured value is buccal inspiratory pression.
7 secondary outcomes
Maximal buccal inspiratory pression (IPmax) using sniff test
Time frame: Day 6 after surgical procedure
Maximal buccal expiratory pression (EPmax) using sniff test
Time frame: Day 6 after surgical procedure
Oxygen saturation rate
Time frame: Day 6 after surgical procedure
medical complication outcome (pneumonia)
Time frame: week 6 after surgical procedure
medical complication outcome (atelectasis)
Time frame: week 6 after surgical procedure
medical complication outcome (pleural effusions)
Time frame: week 6 after surgical procedure
Morphine consummation (Measurement of Morphine consummation since surgery)
Time frame: week 6 after surgical procedure
Results and safety
The study was stopped early (reason given: End of enrollment period, difficulty enrolling patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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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.
Michel SCOTTE, Pr principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sniff test, Infusion of Ropivacaine during 48 hours and Continuous parietal infusion with parietal catheter in people with Hepatectomy, run by University Hospital, Rouen 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 6 inclusion and 9 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 29 Apr 2026. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: End of enrollment period, difficulty enrolling 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?
Buccal Inspiratory Pression (IP) Evaluation of diaphragmatic function using sniff test. (time frame: Day 6 post 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 29 Apr 2026.