The Interest of the Xylocaine® and Ketamine on the Management of Acute and Chronic Ain After Colectomy by Laparoscopy

Study Overview
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Brief Summary
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Recent clinical studies in abdominal surgery have shown that the use of Xylocaine® parenterally intraoperative at plasma concentrations below the toxic threshold of 5 .mu.g / ml, had an analgesic effect and decreased postoperative morphine consumption. This study aims to evaluate the activity of Xylocaine® and ketamine separately administered parenterally, in terms of postoperative morphine consumption and decrease incidences of postoperative chronic pain at 3 and 6 months after laparoscopic colectomy compared the placebo group. The evaluation of the intensity of postoperative pain, hyperalgesia perished skin surface scarring) and pain perception threshold by Pain Matcher® confirm or not the predictive nature of these criteria in the occurrence of chronic pain.

Official Title
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The Interest of the Xylocaine® and Ketamine on the Per and Postoperative Management of Acute and Chronic Postoperative Pain After Colectomy by Laparoscopy

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Xylocaine
* Drug: Ketamine
* Drug: isotonic saline serum intravenous administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Surgery: segmental or total colectomy performed by laparoscopy Anesthesia state 1 and 3 Exclusion Criteria: Patients classified Anesthesia state 4 or 5 Allergy or intolerance to any of the products used in the protocol Creatinine clearance calculated by the Cockcroft formula below 50 ml / min Hepatocellular insufficiency Severe heart failure Peptic ulcer Chronic inflammatory bowel disease (IBD) Previous history of epilepsy or seizures Surgery emergency, palliative surgery, revision surgery Chronic pain requiring regular intake of analgesics include opioids Patients treated with lidocaine patch Psychic Disorder Additive Conduct vis-à-vis alcohol or mind-altering substances Pregnant or breastfeeding women

Ages Eligible for Study
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Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xylocaine<br>intravenous administration | Drug: Xylocaine<br>* Xylocaine is administered at a dose of 1.5 mg / kg for induction and then relay by syringe pump at a dose of 1.33 mg / kg / hour will be administered throughout the duration of the intervention and for 24 hours after the end of thereof, to obtain deemed effective plasma concentrations of the order of 0.5 to 5 mcg / mL.<br>|
| Experimental: Ketamine<br>intravenous administration | Drug: Ketamine<br>* Ketamine will be administered at a dose of 0.5 mg / kg and then relay by syringe pump at a dose of 0.05 mg / kg / hour for the duration of surgery and 24 hours after the end thereof.<br>|
| Placebo Comparator: isotonic saline serum<br>isotonic saline serum intravenous administration | Drug: isotonic saline serum intravenous administration<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption |  | During the first 24 postoperative hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption |  | All 6 hours during the 48 postoperative hours. | 
| Numeric rating scale score |  | All 2 hours during the first 24 postoperative hours and all 6 hours during the 48 postoperative hours. | 
| Electric nociception threshold measured by PainMatcher |  | All 2 hours during the first 24 postoperative hours and all 6 hours during the 48 postoperative hours. | 
| Hyperalgesia of peri-scar (in cm²) with a von Frey filament (pressure of 10 grams |  | At 2 days after postoperative | 
| Questionnaire Douleur de Saint-Antoine (QDSA) , | evaluation with validated scores for chronic and neuropathic pains | at 3 months, at 6 months | 
| Questionnaire d'Evaluation des Douleurs Neuropathiques (QEDN), | evaluation with validated scores for chronic and neuropathic pains | at 3 months, at 6 months | 
| Time physiological function recovery | Ability to drink, to eat, to urinate, to walk | During the first 24 postoperative hours | 
| Duration of hospital stay |  | At 5 days after postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative analgesia, PainMatcher