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

University Hospital, Lille

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pain, Postoperative

Treatments: Drug: Ketamine; Drug: Xylocaine; Drug: isotonic saline serum intravenous administration

Study type: Interventional

Funder types: Other

Identifiers

NCT02969733

2009-017682-33 (EudraCT Number)

2009_05/0943

Details and patient eligibility

About

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.

Enrollment: 135 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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135 participants in 3 patient groups, including a placebo group

Xylocaine

Experimental group

Description:

intravenous administration

Treatment:

Drug: Xylocaine

Ketamine

Experimental group

Description:

intravenous administration

Treatment:

Drug: Ketamine

isotonic saline serum

Placebo Comparator group

Description:

isotonic saline serum intravenous administration

Treatment:

Drug: isotonic saline serum intravenous administration