Efficacy of Local Anesthesic on Diaphragmatic Function After Upper Abdominal Surgery

NCT ID: NCT02353702

Last Updated: 2017-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Group Type EXPERIMENTAL

Sniff test

Intervention Type PROCEDURE

Evaluation of diaphragmatic function by sniff test after continuous parietal infusion of ropivacaine or placebo

Infusion of Ropivacaine during 48 hours

Intervention Type DRUG

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 %.

Continuous parietal infusion with parietal catheter

Intervention Type DEVICE

Continuous parietal infiltration of Ropivacaine or placebo

NaCl

Intervention Type DRUG

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 %)

Group Type PLACEBO_COMPARATOR

Sniff test

Intervention Type PROCEDURE

Evaluation of diaphragmatic function by sniff test after continuous parietal infusion of ropivacaine or placebo

Continuous parietal infusion with parietal catheter

Intervention Type DEVICE

Continuous parietal infiltration of Ropivacaine or placebo

Infusion of placebo during 48 hours

Intervention Type DRUG

NaCl

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sniff test

Evaluation of diaphragmatic function by sniff test after continuous parietal infusion of ropivacaine or placebo

Intervention Type PROCEDURE

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 %.

Intervention Type DRUG

Continuous parietal infusion with parietal catheter

Continuous parietal infiltration of Ropivacaine or placebo

Intervention Type DEVICE

Infusion of placebo during 48 hours

Intervention Type DRUG

NaCl

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michel SCOTTE, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rouen University Hospital

Rouen, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2012/176/HP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.