Efficacy of Local Anesthesic on Diaphragmatic Function After Upper Abdominal Surgery

NCT02353702 | Terminated Phase 3

• 1 other identifier: 2012/176/HP
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatectomy

Keywords

Diaphragmatic function; sniff-test; pulmonary complications; upper abdominal surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Maximal buccal inspiratory pression (IPmax) using sniff test

  Day 6 after surgical procedure

• Maximal buccal expiratory pression (EPmax) using sniff test

  Day 6 after surgical procedure

• Oxygen saturation rate

  Day 6 after surgical procedure

• medical complication outcome (pneumonia)

  week 6 after surgical procedure

• medical complication outcome (atelectasis)

  week 6 after surgical procedure

Study Arms (2)

Infusion of Ropivacaine during 48 hours

EXPERIMENTAL

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; Drug: Infusion of Ropivacaine during 48 hours; Device: Continuous parietal infusion with parietal catheter; Drug: NaCl

Infusion of placebo during 48 hours

PLACEBO COMPARATOR

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; Device: Continuous parietal infusion with parietal catheter; Drug: Infusion of placebo during 48 hours; Drug: NaCl

Interventions

Sniff test PROCEDURE

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

Infusion of Ropivacaine during 48 hours; Infusion of placebo during 48 hours

Infusion of Ropivacaine during 48 hours 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 %.

Infusion of Ropivacaine during 48 hours

NaCl DRUG

Infusion of Ropivacaine during 48 hours; Infusion of placebo during 48 hours

Continuous parietal infusion with parietal catheter DEVICE

Continuous parietal infiltration of Ropivacaine or placebo

Infusion of Ropivacaine during 48 hours; Infusion of placebo during 48 hours

Infusion of placebo during 48 hours DRUG

Infusion of placebo during 48 hours

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• BMI more than 30 kg/m2
• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, 76031, France

Location

Study Officials

• Michel SCOTTE, Pr

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: February 3, 2015
• Study Start: July 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: April 29, 2026

Record last verified: 2017-08

Locations

FR (1)