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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ropivacaine | Experimental | patients scheduled to undergo open liver resection Age > 18 years Free from pain in preoperative period |
|
| placebo | Placebo Comparator | patients scheduled to undergo open liver resection Age > 18 years Free from pain in preoperative period |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| wound infusion ropivacaine | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| the opioid-related symptom distress scale (SDS) | 48 h postoperatively |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thibault Camus, Dr | Assistance Publique | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Département anesthésie-réanimation | Paris | 75012 | France |
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| 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 |