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Efficacy of parietal continous infiltration of local anesthesic on diaphragmatic function after upper abdominal surgery through a subcostal incision

Efficacy of parietal continous infiltration of local anesthesic on diaphragmatic function after upper abdominal surgery through a subcostal incision - CATPAR

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-002184-26-FR
Enrollment
Unknown
Registered
2015-09-28
Start date
2014-01-20
Completion date
Unknown
Last updated
2015-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaphragmatic function after upper abdominal surgery through a subcostal incision MedDRA version: 18.0 Level: HLT Classification code 10012706 Term: Diaphragmatic disorders System Organ Class: 100000004855

Interventions

Trade Name: NAROPEINE Product Name: NAROPEINE Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: ANHYDROUS ROPIVACAINE HYDROCHLORIDE CAS Number: 98717-15-8 Concentration unit: m

Sponsors

CHU de Rouen
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Upper abdominal surgery through subcostal incision - More than 18 years old , less tha 80 years old - ASA 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 28

Exclusion criteria

Exclusion criteria: - BMI more than 30 kg/m2 - Functionnal state of total dependence - Nasal obstruction during inclusion - Preoperative treatment with morphin - 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

Design outcomes

Primary

MeasureTime frame
Main Objective: Evaluation by the sniff test of the effect of continous parietal analgesia with ropivacaine on diaphragmatic function after upper abdominal surgery;Secondary Objective: Evaluation of the effect of continous parietal analgesia with ropivacaine on : - IPmax and EPmax - Oxygen saturation - Post operative pulmonary complications (pneumonia, atelectasis, pleural effusions) - Morphin consommation - Post operative recovery ;Primary end point(s): Measure of diaphragmatic function with the sniff-test;Timepoint(s) of evaluation of this end point: V1 (inclusion), V2 (after surgery (H0) : H24, H48, H72, H96, H120, Day 6), V3 (day 7) and V4 (6 weeks)—

Secondary

MeasureTime frame
Secondary end point(s): - Measure of diaphragmatic function with maximal buccal inspiratory pression (IPmax) and maximal buccal expriratory pression (EPmax) - Oxygen saturation - Pulmonary complications : pneumonia, atlectasia, pleural effusions - Morphin consommation and associated complications (nausea, vomiting, somnolence) ;Timepoint(s) of evaluation of this end point: V1 (inclusion), V2 (after surgery (H0) : H6, H24, H48, H72, H96, H120, Day 6), V3 (day 7) and V4 (6 weeks) PEmax and PImax are not performed at V2 (H6)—

Countries

France

Contacts

Public ContactPatrice TESTUT

CHU de Rouen

patrice.testut@chu-rouen.fr+33232888265

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026