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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Laparotomy, Hepatic Resection

Intervention / Treatment
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* Drug: wound infusion ropivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ropivacaine<br>patients scheduled to undergo open liver resection Age > 18 years Free from pain in preoperative period | Drug: wound infusion ropivacaine<br>* 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.<br>|
| Placebo Comparator: placebo<br>patients scheduled to undergo open liver resection Age > 18 years Free from pain in preoperative period | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the opioid-related symptom distress scale (SDS) |  | 48 h postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragmatic function | Sniff-test and Peak-flow | 48 h, 5 days postoperatively and discharge | 
| total morphine consumption |  | 48 h, 5 days postoperatively and discharge | 
| Recovery after surgery | It is defined as the time to first flatus and recovery of bowel activity after surgery | 48 h, 5 days postoperatively and discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post operative recovery, Laparotomy, Hepatic resection, continuous wound catheter analgesia, morphine