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

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ClinicalTrials.gov Identifier: NCT02353702
Recruitment Status : Completed
First Posted : February 3, 2015
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Hepatectomy Procedure: Sniff test Drug: Infusion of Ropivacaine during 48 hours Device: Continuous parietal infusion with parietal catheter Drug: Infusion of placebo during 48 hours Drug: NaCl Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Parietal Continuous Infiltration of Local Anesthesic on Diaphragmatic Function After Upper Abdominal Surgery Through a Subcostal Incision
Actual Study Start Date : July 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Arm Intervention/treatment
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)

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

Drug: NaCl
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 %)

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
Drug: NaCl



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Oxygen saturation rate [ Time Frame: Day 6 after surgical procedure ]
    Evaluation of Oxygen saturation

  4. medical complication outcome (pneumonia) [ Time Frame: week 6 after surgical procedure ]
    Medical pulmonary complications outcome : pneumonia

  5. medical complication outcome (atelectasis) [ Time Frame: week 6 after surgical procedure ]
    Medical pulmonary complications outcome : atelectasis

  6. medical complication outcome (pleural effusions) [ Time Frame: week 6 after surgical procedure ]
    Medical pulmonary complications outcome : pleural effusions

  7. Morphine consummation (Measurement of Morphine consummation since surgery) [ Time Frame: week 6 after surgical procedure ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353702


Locations
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France
Rouen University Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: Michel SCOTTE, Pr Rouen University Hospital
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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02353702    
Other Study ID Numbers: 2012/176/HP
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Keywords provided by University Hospital, Rouen:
Diaphragmatic function
sniff-test
pulmonary complications
upper abdominal surgery
Additional relevant MeSH terms:
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Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents