Hepatectomy
Conditions
Keywords
Diaphragmatic function, sniff-test, pulmonary complications, upper abdominal surgery
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.
Interventions
PROCEDURESniff test
Evaluation of diaphragmatic function by sniff test after continuous parietal infusion of ropivacaine or placebo
DRUGInfusion 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 %.
DEVICEContinuous parietal infusion with parietal catheter
Continuous parietal infiltration of Ropivacaine or placebo
DRUGInfusion of placebo during 48 hours
DRUGNaCl
Sponsors
University Hospital, Rouen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Buccal Inspiratory Pression (IP) Evaluation of diaphragmatic function using sniff test. | Day 6 post surgery | Evaluation of diaphragmatic function using sniff test. The measured value is buccal inspiratory pression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximal buccal inspiratory pression (IPmax) using sniff test | Day 6 after surgical procedure | Evaluation of maximal buccal inspiratory pression (IPmax) using sniff test |
| Maximal buccal expiratory pression (EPmax) using sniff test | Day 6 after surgical procedure | Evaluation of maximal buccal expiratory pression (EPmax) using sniff test |
| Oxygen saturation rate | Day 6 after surgical procedure | Evaluation of Oxygen saturation |
| medical complication outcome (pneumonia) | week 6 after surgical procedure | Medical pulmonary complications outcome : pneumonia |
| medical complication outcome (atelectasis) | week 6 after surgical procedure | Medical pulmonary complications outcome : atelectasis |
| medical complication outcome (pleural effusions) | week 6 after surgical procedure | Medical pulmonary complications outcome : pleural effusions |
| Morphine consummation (Measurement of Morphine consummation since surgery) | week 6 after surgical procedure | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORMichel SCOTTE, Pr
University Hospital, Rouen
Outcome results
None listed