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

University Hospital, Rouen

Status and phase: Completed; Phase 3

Conditions: Hepatectomy

Treatments: Drug: Infusion of placebo during 48 hours; Drug: NaCl; Drug: Infusion of Ropivacaine during 48 hours; Procedure: Sniff test; Device: Continuous parietal infusion with parietal catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT02353702

2012/176/HP

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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31 participants in 2 patient groups, including a placebo group

Infusion of Ropivacaine during 48 hours

Experimental group

Description:

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)

Treatment:

Drug: NaCl

Drug: Infusion of Ropivacaine during 48 hours

Device: Continuous parietal infusion with parietal catheter

Procedure: Sniff test

Infusion of placebo during 48 hours

Placebo Comparator group

Description:

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 %)

Treatment:

Drug: NaCl

Drug: Infusion of placebo during 48 hours

Device: Continuous parietal infusion with parietal catheter

Procedure: Sniff test