Efficacy of Local Anesthesic on Diaphragmatic Function After Upper Abdominal Surgery

Phase 3

Completed

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

• Registration Number: NCT02353702
• Lead Sponsor: University Hospital, Rouen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2015-01-22
• Study First Submitted QC: 2015-02-02
• Study First Posted: 2015-02-03
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-21
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infusion of placebo during 48 hours	NaCl	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 %)
Infusion of Ropivacaine during 48 hours	NaCl	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)
Infusion of placebo during 48 hours	Continuous parietal infusion with parietal catheter	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 %)
Infusion of Ropivacaine during 48 hours	Sniff test	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)
Infusion of placebo during 48 hours	Infusion of placebo during 48 hours	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 %)
Infusion of Ropivacaine during 48 hours	Infusion of Ropivacaine during 48 hours	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)
Infusion of Ropivacaine during 48 hours	Continuous parietal infusion with parietal catheter	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)
Infusion of placebo during 48 hours	Sniff test	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 %)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France