A Phase 2/3 interventional study of Xylocaine and Ketamine in Pain, Postoperative, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-12.
Sponsored by University Hospital, Lille · Phase 2/3, Interventional, and Treatment
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.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 135 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →University Hospital, Lille is the lead sponsor of 630 studies on the registry; 141 are open to participants now.
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Exclusion Criteria:
intravenous administration
Drug: Xylocaine
intravenous administration
Drug: Ketamine
isotonic saline serum intravenous administration
Drug: isotonic saline serum intravenous administration
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.
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.
Morphine consumption
Time frame: During the first 24 postoperative hours.
Morphine consumption
Time frame: All 6 hours during the 48 postoperative hours.
Numeric rating scale score
Time frame: All 2 hours during the first 24 postoperative hours and all 6 hours during the 48 postoperative hours.
Electric nociception threshold measured by PainMatcher
Time frame: 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
Time frame: At 2 days after postoperative
Questionnaire Douleur de Saint-Antoine (QDSA) ,
evaluation with validated scores for chronic and neuropathic pains
Time frame: at 3 months, at 6 months
Questionnaire d'Evaluation des Douleurs Neuropathiques (QEDN),
evaluation with validated scores for chronic and neuropathic pains
Time frame: at 3 months, at 6 months
Time physiological function recovery
Ability to drink, to eat, to urinate, to walk
Time frame: During the first 24 postoperative hours
Duration of hospital stay
Time frame: At 5 days after postoperative
Plan to share: No
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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Lidocaine · Ketamine