Efficacy of Local Anesthesic on Diaphragmatic Function After Upper Abdominal Surgery (CATPAR)

April 23, 2026 updated by: University Hospital, Rouen

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76031
        • Rouen University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Pregnant women or breasting women
  • Patients under guardianship
  • Contraindication to use of ropivacaine
  • Inclusion in another clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Infusion of Ropivacaine during 48 hours

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)
Drug: NaCl
Procedure: Sniff test
Evaluation of diaphragmatic function by sniff test after continuous parietal infusion of ropivacaine or placebo
Drug: Infusion of Ropivacaine during 48 hours

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 %.

Device: Continuous parietal infusion with parietal catheter
Continuous parietal infiltration of Ropivacaine or placebo
Placebo Comparator: Infusion of placebo during 48 hours

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 %)
Drug: NaCl
Procedure: Sniff test
Evaluation of diaphragmatic function by sniff test after continuous parietal infusion of ropivacaine or placebo
Device: Continuous parietal infusion with parietal catheter
Continuous parietal infiltration of Ropivacaine or placebo
Drug: Infusion of placebo during 48 hours

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 6 post surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximal buccal inspiratory pression (IPmax) using sniff test
Time Frame: Day 6 after surgical procedure
Evaluation of maximal buccal inspiratory pression (IPmax) using sniff test
Day 6 after surgical procedure
Maximal buccal expiratory pression (EPmax) using sniff test
Time Frame: Day 6 after surgical procedure
Evaluation of maximal buccal expiratory pression (EPmax) using sniff test
Day 6 after surgical procedure
Oxygen saturation rate
Time Frame: Day 6 after surgical procedure
Evaluation of Oxygen saturation
Day 6 after surgical procedure
medical complication outcome (pneumonia)
Time Frame: week 6 after surgical procedure
Medical pulmonary complications outcome : pneumonia
week 6 after surgical procedure
medical complication outcome (atelectasis)
Time Frame: week 6 after surgical procedure
Medical pulmonary complications outcome : atelectasis
week 6 after surgical procedure
medical complication outcome (pleural effusions)
Time Frame: week 6 after surgical procedure
Medical pulmonary complications outcome : pleural effusions
week 6 after surgical procedure
Morphine consummation (Measurement of Morphine consummation since surgery)
Time Frame: week 6 after surgical procedure
week 6 after surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Rouen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michel SCOTTE, Pr, University Hospital, Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2012/176/HP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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