NCT02353702

Efficacy of Local Anesthesic on Diaphragmatic Function After Upper Abdominal Surgery

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatectomy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-07-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2015-02-03
• Last updated: 2017-08-22

Locations

1 site across 1 country: France