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

Ketamine

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.

Intervention / Treatment

  • Xylocaine (DRUG)
    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 (DRUG)
    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.
  • isotonic saline serum intravenous administration (DRUG)
    N/A

Condition or Disease

  • Pain, Postoperative

Phase

  • Phase 2
  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 135 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Jan 01, 2011
    Primary Completion: Sep 01, 2017 ACTUAL
    Completion Date: Sep 01, 2017 ACTUAL
    Study First Posted: Nov 21, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Sep 11, 2017

    Sponsors / Collaborators

    Lead Sponsor: University Hospital, Lille
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Lille, Hauts-de-France, France

    Participant Groups

    • intravenous administration

    • intravenous administration

    • isotonic saline serum intravenous administration

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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
    • Morphine consumption During the first 24 postoperative hours.
    Secondary Outcomes
    • 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

    • evaluation with validated scores for chronic and neuropathic pains

    • evaluation with validated scores for chronic and neuropathic pains

    • Ability to drink, to eat, to urinate, to walk

    • Duration of hospital stay At 5 days after postoperative

    More Details

    NCT Number: NCT02969733
    Acronym: KETALIDO
    Other IDs: 2009_05/0943
    Study URL: https://clinicaltrials.gov/study/NCT02969733
    Last updated: Sep 29, 2023