Clinical trial NCT02969733: The Interest of the Xylocaine® and Ketamine on the Management of Acute and Chronic Ain After Colectomy by Laparoscopy
Official title: The Interest of the Xylocaine® and Ketamine on the Per and Postoperative Management of Acute and Chronic Postoperative Pain After Colectomy by Laparoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pain, Postoperative
Keywords: postoperative analgesia
PainMatcher
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Morphine consumption
timeFrame: During the first 24 postoperative hours.
Secondary outcomes:
measure: Morphine consumption
timeFrame: All 6 hours during the 48 postoperative hours.
measure: Numeric rating scale score
timeFrame: All 2 hours during the first 24 postoperative hours and all 6 hours during the 48 postoperative hours.
measure: Electric nociception threshold measured by PainMatcher
timeFrame: All 2 hours during the first 24 postoperative hours and all 6 hours during the 48 postoperative hours.
measure: Hyperalgesia of peri-scar (in cm²) with a von Frey filament (pressure of 10 grams
timeFrame: At 2 days after postoperative
measure: Questionnaire Douleur de Saint-Antoine (QDSA) ,
timeFrame: at 3 months, at 6 months
measure: Questionnaire d'Evaluation des Douleurs Neuropathiques (QEDN),
timeFrame: at 3 months, at 6 months
measure: Time physiological function recovery
timeFrame: During the first 24 postoperative hours
measure: Duration of hospital stay
timeFrame: At 5 days after postoperative
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU, Hôpital Claude Huriez
Study officials:
affiliation: University Hospital, Lille
name: Gilles Lebuffe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: