Efficacy of Local Anesthesic on Diaphragmatic Function After Upper Abdominal Surgery

Hepatectomy Clinical Trial

— CATPAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02353702
• Other study ID #: 2012/176/HP
• Status: Completed
• Phase: Phase 3
• First received: January 22, 2015
• Last updated: August 21, 2017
• Start date: July 2014
• Est. completion date: June 2017

Study information

• Verified date: August 2017
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatectomy

Intervention

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

• NaCl

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Buccal Inspiratory Pression (IP) Evaluation of diaphragmatic function using sniff test.	Evaluation of diaphragmatic function using sniff test. The measured value is buccal inspiratory pression.	Day 6 post surgery
Secondary	Maximal buccal inspiratory pression (IPmax) using sniff test	Evaluation of maximal buccal inspiratory pression (IPmax) using sniff test	Day 6 after surgical procedure
Secondary	Maximal buccal expiratory pression (EPmax) using sniff test	Evaluation of maximal buccal expiratory pression (EPmax) using sniff test	Day 6 after surgical procedure
Secondary	Oxygen saturation rate	Evaluation of Oxygen saturation	Day 6 after surgical procedure
Secondary	medical complication outcome (pneumonia)	Medical pulmonary complications outcome : pneumonia	week 6 after surgical procedure
Secondary	medical complication outcome (atelectasis)	Medical pulmonary complications outcome : atelectasis	week 6 after surgical procedure
Secondary	medical complication outcome (pleural effusions)	Medical pulmonary complications outcome : pleural effusions	week 6 after surgical procedure
Secondary	Morphine consummation (Measurement of Morphine consummation since surgery)		week 6 after surgical procedure