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TERMINATED
NCT02353702
PHASE3

Efficacy of Local Anesthesic on Diaphragmatic Function After Upper Abdominal Surgery

Sponsor: University Hospital, Rouen

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

31

Start Date

2014-07

Completion Date

2017-06

Last Updated

2026-04-29

Healthy Volunteers

No

Conditions

Interventions

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

Infusion of placebo during 48 hours

DRUG

NaCl

Locations (1)

Rouen University Hospital

Rouen, France