Pain, Postoperative
Conditions
Keywords
postoperative analgesia, PainMatcher
Brief summary
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.
Interventions
DRUGXylocaine
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.
DRUGKetamine
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.
DRUGisotonic saline serum intravenous administration
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Morphine consumption | During the first 24 postoperative hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Morphine consumption | All 6 hours during the 48 postoperative hours. | — |
| Questionnaire d'Evaluation des Douleurs Neuropathiques (QEDN), | at 3 months, at 6 months | evaluation with validated scores for chronic and neuropathic pains |
| Time physiological function recovery | During the first 24 postoperative hours | Ability to drink, to eat, to urinate, to walk |
| Duration of hospital stay | At 5 days after postoperative | — |
| Questionnaire Douleur de Saint-Antoine (QDSA) , | at 3 months, at 6 months | evaluation with validated scores for chronic and neuropathic pains |
Countries
France
Outcome results
None listed