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In this multicenter, randomised, placebo-controlled, double-blind trial, hyperalgesia area around the scarce following colorectal laparoscopic surgery (piece removal) will be assessed in 3 groups of patients : group 1: continuous ropivacaine preperitoneal infusion, group 2 : intravenous lidocaine infusion, or group 3 : control group without local anesthetics. All patients will receive parenteral analgesia combining acetaminophen and morphine.
Besides hyperalgesia assessment, immediate postoperative and long-term pain, morphine consumption, and endocrin-metabolic response will be evaluated in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Patients with continuous ropivacaine preperitoneal infusion |
|
| 2 | Active Comparator | Patients with intravenous lidocaine infusion |
|
| 3 | Placebo Comparator | Patients without local anesthetics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| continuous ropivacaine preperitoneal infusion | Drug | Bolus of 20 mg after the surgery then 20 mg per hour during 48 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pericicatricial hyperalgesia area | 72 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity (rest/mobilization and long-term) | 72 hours, 3 months and 6 months after surgery | |
| Morphine consumption | During 5 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Beaussier, MD PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departement d'Anesthesie-Reanimation, Hopital Saint-Antoine | Paris | 75012 | France |
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| intravenous lidocaine infusion | Drug | Bolus of 60 mg after the surgery then 60 mg per hour during 48 hours |
|
| parenteral analgesia combining acetaminophen and morphine | Drug | parenteral analgesia combining acetaminophen and morphine |
|
| NaCl | Drug | NaCl |
|
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D006930 | Hyperalgesia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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