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

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Xylocaine
Ketamine
isotonic saline serum intravenous administration
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring postoperative analgesia, PainMatcher

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHRU, Hôpital Claude Huriez

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Xylocaine

Ketamine

isotonic saline serum

Arm Description

intravenous administration

intravenous administration

isotonic saline serum intravenous administration

Outcomes

Primary Outcome Measures

Morphine consumption

Secondary Outcome Measures

Morphine consumption
Numeric rating scale score
Electric nociception threshold measured by PainMatcher
Hyperalgesia of peri-scar (in cm²) with a von Frey filament (pressure of 10 grams
Questionnaire Douleur de Saint-Antoine (QDSA) ,
evaluation with validated scores for chronic and neuropathic pains
Questionnaire d'Evaluation des Douleurs Neuropathiques (QEDN),
evaluation with validated scores for chronic and neuropathic pains
Time physiological function recovery
Ability to drink, to eat, to urinate, to walk
Duration of hospital stay

Full Information

First Posted
November 14, 2016
Last Updated
September 11, 2017
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT02969733
Brief Title
The Interest of the Xylocaine® and Ketamine on the Management of Acute and Chronic Ain After Colectomy by Laparoscopy
Acronym
KETALIDO
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

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
postoperative analgesia, PainMatcher

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Xylocaine
Arm Type
Experimental
Arm Description
intravenous administration
Arm Title
Ketamine
Arm Type
Experimental
Arm Description
intravenous administration
Arm Title
isotonic saline serum
Arm Type
Placebo Comparator
Arm Description
isotonic saline serum intravenous administration
Intervention Type
Drug
Intervention Name(s)
Xylocaine
Intervention Description
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
Intervention Name(s)
Ketamine
Intervention Description
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
Intervention Name(s)
isotonic saline serum intravenous administration
Primary Outcome Measure Information:
Title
Morphine consumption
Time Frame
During the first 24 postoperative hours.
Secondary Outcome Measure Information:
Title
Morphine consumption
Time Frame
All 6 hours during the 48 postoperative hours.
Title
Numeric rating scale score
Time Frame
All 2 hours during the first 24 postoperative hours and all 6 hours during the 48 postoperative hours.
Title
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.
Title
Hyperalgesia of peri-scar (in cm²) with a von Frey filament (pressure of 10 grams
Time Frame
At 2 days after postoperative
Title
Questionnaire Douleur de Saint-Antoine (QDSA) ,
Description
evaluation with validated scores for chronic and neuropathic pains
Time Frame
at 3 months, at 6 months
Title
Questionnaire d'Evaluation des Douleurs Neuropathiques (QEDN),
Description
evaluation with validated scores for chronic and neuropathic pains
Time Frame
at 3 months, at 6 months
Title
Time physiological function recovery
Description
Ability to drink, to eat, to urinate, to walk
Time Frame
During the first 24 postoperative hours
Title
Duration of hospital stay
Time Frame
At 5 days after postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles Lebuffe, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU, Hôpital Claude Huriez
City
Lille
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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