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

Pain, Postoperative Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02969733
• Other study ID #: 2009_05/0943
• Secondary ID: 2009-017682-33
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 14, 2016
• Last updated: September 11, 2017
• Start date: January 2011
• Est. completion date: September 2017

Study information

• Verified date: September 2017
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• 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.
• 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.
• isotonic saline serum intravenous administration

Locations

Country	Name	City	State
France	CHRU, Hôpital Claude Huriez	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption		During the first 24 postoperative hours.
Secondary	Morphine consumption		All 6 hours during the 48 postoperative hours.
Secondary	Numeric rating scale score		All 2 hours during the first 24 postoperative hours and all 6 hours during the 48 postoperative hours.
Secondary	Electric nociception threshold measured by PainMatcher		All 2 hours during the first 24 postoperative hours and all 6 hours during the 48 postoperative hours.
Secondary	Hyperalgesia of peri-scar (in cm²) with a von Frey filament (pressure of 10 grams		At 2 days after postoperative
Secondary	Questionnaire Douleur de Saint-Antoine (QDSA) ,	evaluation with validated scores for chronic and neuropathic pains	at 3 months, at 6 months
Secondary	Questionnaire d'Evaluation des Douleurs Neuropathiques (QEDN),	evaluation with validated scores for chronic and neuropathic pains	at 3 months, at 6 months
Secondary	Time physiological function recovery	Ability to drink, to eat, to urinate, to walk	During the first 24 postoperative hours
Secondary	Duration of hospital stay		At 5 days after postoperative