Efficacy of Local Anesthesic on Diaphragmatic Function After Upper Abdominal Surgery (NCT02353702) | Clinical Trial Compass
TerminatedPhase 3
Efficacy of Local Anesthesic on Diaphragmatic Function After Upper Abdominal Surgery
Stopped: End of enrollment period, difficulty enrolling patients
France31 participantsStarted 2014-07
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Buccal Inspiratory Pression (IP) Evaluation of diaphragmatic function using sniff test.