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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2017-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Xylocaine

intravenous administration

Group Type EXPERIMENTAL

Xylocaine

Intervention Type 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

intravenous administration

Group Type EXPERIMENTAL

Ketamine

Intervention Type 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

isotonic saline serum intravenous administration

Group Type PLACEBO_COMPARATOR

isotonic saline serum intravenous administration

Intervention Type DRUG

Interventions

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Xylocaine

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.

Intervention Type DRUG

Ketamine

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.

Intervention Type DRUG

isotonic saline serum intravenous administration

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No