Efficacy of Local Anesthesic on Diaphragmatic Function After Upper Abdominal Surgery (CATPAR)

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatectomy
• Intervention / Treatment: Drug: NaCl; Procedure: Sniff test; Drug: Infusion of Ropivacaine during 48 hours; Device: Continuous parietal infusion with parietal catheter; Drug: Infusion of placebo during 48 hours

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76031
    • ROUEN university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: NaCl; 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
Placebo Comparator: 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 %)	Drug: NaCl; Procedure: Sniff test; Evaluation of diaphragmatic function by sniff test after continuous parietal infusion of ropivacaine or placebo; Device: Continuous parietal infusion with parietal catheter; Continuous parietal infiltration of Ropivacaine or placebo; Drug: Infusion of placebo during 48 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal buccal inspiratory pression (IPmax) using sniff test	Evaluation of maximal buccal inspiratory pression (IPmax) using sniff test	Day 6 after surgical procedure
Maximal buccal expiratory pression (EPmax) using sniff test	Evaluation of maximal buccal expiratory pression (EPmax) using sniff test	Day 6 after surgical procedure
Oxygen saturation rate	Evaluation of Oxygen saturation	Day 6 after surgical procedure
medical complication outcome (pneumonia)	Medical pulmonary complications outcome : pneumonia	week 6 after surgical procedure
medical complication outcome (atelectasis)	Medical pulmonary complications outcome : atelectasis	week 6 after surgical procedure
medical complication outcome (pleural effusions)	Medical pulmonary complications outcome : pleural effusions	week 6 after surgical procedure
Morphine consummation (Measurement of Morphine consummation since surgery)		week 6 after surgical procedure

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Michel SCOTTE, Pr, ROUEN university hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: January 22, 2015
• First Submitted That Met QC Criteria: February 2, 2015
• First Posted (Estimate): February 3, 2015

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 21, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: pulmonary complications; upper abdominal surgery; Diaphragmatic function; sniff-test
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 2012/176/HP