Skip to main content
OpenTrials
Completed

NCT Number: NCT02969733

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

CHRU, Hôpital Claude Huriez

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Morphine consumption

    Time frame: During the first 24 postoperative hours.

Secondary outcomes

  1. Morphine consumption

    Time frame: All 6 hours during the 48 postoperative hours.

  2. Numeric rating scale score

    Time frame: All 2 hours during the first 24 postoperative hours and all 6 hours during the 48 postoperative hours.

  3. 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.

  4. Hyperalgesia of peri-scar (in cm²) with a von Frey filament (pressure of 10 grams

    Time frame: At 2 days after postoperative

  5. Questionnaire Douleur de Saint-Antoine (QDSA) ,

    Time frame: at 3 months, at 6 months

    evaluation with validated scores for chronic and neuropathic pains

  6. Questionnaire d'Evaluation des Douleurs Neuropathiques (QEDN),

    Time frame: at 3 months, at 6 months

    evaluation with validated scores for chronic and neuropathic pains

  7. Time physiological function recovery

    Time frame: During the first 24 postoperative hours

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

  8. Duration of hospital stay

    Time frame: At 5 days after postoperative

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: KETALIDO

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Nov 21, 2016
Registry last updated
Sep 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.