Continuous Preperitoneal Infusion of Ropivacaine After Open Liver Resection: Effect on Post-operative Recovery and Morbidity.

NCT ID: NCT01890408

Last Updated: 2014-06-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-02-28

Brief Summary

Intravenous morphine Patient-Controlled analgesia is gold standard on post - operative liver resection. But, opioids tend to be ineffective for pain that is associated with movement and have significant short-term side effects including nausea, vomiting, sedation, pruritus, constipation, urinary, retention, and respiratory depression, which are factors that often hinder a patient's recovery. Prospective randomized trials has found continuous wound catheter analgesia as an accepted alternative to IV morphine PCA.

The researchers will investigate whether ropivacaine, administered through a wound catheter placed by the surgeon, will reduce morbidity and provide a better recovery.

Detailed Description

This study is a prospective, double blind, randomized study. Subjects will be randomized using a computer-generated table of random numbers into 2 groups. The patients scheduled to undergo open liver resection will be randomly allocated to receive a continuous wound infusion of either 0.2% ropivacaine (ropivacaine group A) or 0.9% saline (control group B). The patients will be thereafter randomly assigned to receive through the catheter either 0.2% ropivacaine (study group) (10-ml bolus followed by an infusion of 10 ml/h during 48 h) or the same protocol with 0.9% NaCl (control group), thanks to a elastomeric pump (500ml), set to deliver a 10-ml/h connected with the catheter. In addition, all patients will receive patient-controlled intravenous morphine analgesia. The primary endpoint : the opioid-related symptom distress scale (SDS) will be performed at 48 hours after surgery. Secondary endpoints will be pain intensity on a visual analog scale at rest, and on coughing, morphine consumption, respiratory dysfunction, transit recovery and side effects at 48 hours, 5 days after surgery.

Conditions

Laparotomy; Hepatic Resection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ropivacaine

patients scheduled to undergo open liver resection Age \> 18 years Free from pain in preoperative period

Group Type: EXPERIMENTAL

wound infusion ropivacaine

Intervention Type: DRUG

Laparotomy Hepatic surgery :

Bolu of 10 ml de ropivacaine 0,2% + infusion with elastomeric pump with ropivacaine 0,2% at a 10ml/h during 48 hours.

placebo

patients scheduled to undergo open liver resection Age \> 18 years Free from pain in preoperative period

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

wound infusion ropivacaine

Laparotomy Hepatic surgery :

Bolu of 10 ml de ropivacaine 0,2% + infusion with elastomeric pump with ropivacaine 0,2% at a 10ml/h during 48 hours.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• ASA I-III
• Scheduled for open hepatic resection
• Patients must be able to understand the IV morphine PCA
• Written informed consent
• Free from pain in preoperative period

Exclusion Criteria

• Age < 18 years
• Severe hepatic
• Renal impairment
• Pregnancy or lactation
• Allergy to one of the specific drugs under study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thibault Camus, Dr

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique

Locations

Département anesthésie-réanimation

Paris, , France

Countries

France

Other Identifiers

P111101

Identifier Type: -

Identifier Source: org_study_id