Clinical trial NCT02353702: Efficacy of Local Anesthesic on Diaphragmatic Function After Upper Abdominal Surgery
Official title: Efficacy of Parietal Continuous Infiltration of Local Anesthesic on Diaphragmatic Function After Upper Abdominal Surgery Through a Subcostal Incision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatectomy
Keywords: Diaphragmatic function
sniff-test
pulmonary complications
upper abdominal surgery
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2015-02-03
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Buccal Inspiratory Pression (IP) Evaluation of diaphragmatic function using sniff test.
timeFrame: Day 6 post surgery
Secondary outcomes:
measure: Maximal buccal inspiratory pression (IPmax) using sniff test
timeFrame: Day 6 after surgical procedure
measure: Maximal buccal expiratory pression (EPmax) using sniff test
timeFrame: Day 6 after surgical procedure
measure: Oxygen saturation rate
timeFrame: Day 6 after surgical procedure
measure: medical complication outcome (pneumonia)
timeFrame: week 6 after surgical procedure
measure: medical complication outcome (atelectasis)
timeFrame: week 6 after surgical procedure
measure: medical complication outcome (pleural effusions)
timeFrame: week 6 after surgical procedure
measure: Morphine consummation (Measurement of Morphine consummation since surgery)
timeFrame: week 6 after surgical procedure
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Michel SCOTTE, Pr
role: PRINCIPAL_INVESTIGATOR
References: