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

Phase 2

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: isotonic saline serum intravenous administration; Drug: Ketamine; Drug: Xylocaine

• Registration Number: NCT02969733
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2016-11-14
• Study First Submitted QC: 2016-11-17
• Study First Posted: 2016-11-21
• Status Verified: 2017-09
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Last Update Submitted: 2017-09-11
• Last Update Posted: 2017-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
isotonic saline serum	isotonic saline serum intravenous administration	isotonic saline serum intravenous administration
Ketamine	Ketamine	intravenous administration
Xylocaine	Xylocaine	intravenous administration

Primary Outcome Measures

Name	Time	Method
Morphine consumption	During the first 24 postoperative hours.

Secondary Outcome Measures

Name	Time	Method
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.
Questionnaire Douleur de Saint-Antoine (QDSA) ,	at 3 months, at 6 months	evaluation with validated scores for chronic and neuropathic pains
Hyperalgesia of peri-scar (in cm²) with a von Frey filament (pressure of 10 grams	At 2 days after postoperative
Time physiological function recovery	During the first 24 postoperative hours	Ability to drink, to eat, to urinate, to walk
Duration of hospital stay	At 5 days after postoperative
Questionnaire d'Evaluation des Douleurs Neuropathiques (QEDN),	at 3 months, at 6 months	evaluation with validated scores for chronic and neuropathic pains

Trial Locations

Locations (1)

CHRU, Hôpital Claude Huriez; 🇫🇷 Lille, France