Efficacy of Local Anesthesic on Diaphragmatic Function After Upper Abdominal Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Parietal Continuous Infiltration of Local Anesthesic on Diaphragmatic Function After Upper Abdominal Surgery Through a Subcostal Incision

Conditions
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Hepatectomy

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infusion of Ropivacaine during 48 hours<br>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<br>* Evaluation of diaphragmatic function by sniff test after continuous parietal infusion of ropivacaine or placebo<br>Drug: Infusion of Ropivacaine during 48 hours<br>* 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 %.<br>Device: Continuous parietal infusion with parietal catheter<br>* Continuous parietal infiltration of Ropivacaine or placebo<br>Drug: NaCl<br> <br> |
| Placebo Comparator: Infusion of placebo during 48 hours<br>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<br>* Evaluation of diaphragmatic function by sniff test after continuous parietal infusion of ropivacaine or placebo<br>Device: Continuous parietal infusion with parietal catheter<br>* Continuous parietal infiltration of Ropivacaine or placebo<br>Drug: Infusion of placebo during 48 hours<br> <br> Drug: NaCl<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 6 post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal buccal inspiratory pression (IPmax) using sniff test | Evaluation of maximal buccal inspiratory pression (IPmax) using sniff test | Day 6 after surgical procedure | 
| Maximal buccal expiratory pression (EPmax) using sniff test | Evaluation of maximal buccal expiratory pression (EPmax) using sniff test | Day 6 after surgical procedure | 
| Oxygen saturation rate | Evaluation of Oxygen saturation | Day 6 after surgical procedure | 
| medical complication outcome (pneumonia) | Medical pulmonary complications outcome : pneumonia | week 6 after surgical procedure | 
| medical complication outcome (atelectasis) | Medical pulmonary complications outcome : atelectasis | week 6 after surgical procedure | 
| medical complication outcome (pleural effusions) | Medical pulmonary complications outcome : pleural effusions | week 6 after surgical procedure | 
| Morphine consummation (Measurement of Morphine consummation since surgery) |  | week 6 after surgical procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diaphragmatic function, sniff-test, pulmonary complications, upper abdominal surgery