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

Sponsor

University Hospital, Rouen (Other)

Overall Status

Completed

CT.gov ID

NCT02353702

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatectomy	Procedure: Sniff test Drug: Infusion of Ropivacaine during 48 hours Device: Continuous parietal infusion with parietal catheter Drug: Infusion of placebo during 48 hours Drug: NaCl	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

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)	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: NaCl
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 %)	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 Drug: NaCl

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)

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: NaCl

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 %)

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

Drug: NaCl

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rouen University Hospital	Rouen		France	76031

Sponsors and Collaborators

University Hospital, Rouen

Investigators

Principal Investigator: Michel SCOTTE, Pr, Rouen University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Rouen

ClinicalTrials.gov Identifier:

NCT02353702

Other Study ID Numbers:

2012/176/HP

First Posted:

Feb 3, 2015

Last Update Posted:

Aug 22, 2017

Last Verified:

Aug 1, 2017

Keywords provided by University Hospital, Rouen

Diaphragmatic function

sniff-test

pulmonary complications

upper abdominal surgery

Additional relevant MeSH terms:

Ropivacaine

Study Results

No Results Posted as of Aug 22, 2017