NCT02969733

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 12, 2017

Status Verified

September 1, 2017

Enrollment Period

6.7 years

First QC Date

November 14, 2016

Last Update Submit

September 11, 2017

Conditions

Pain, Postoperative

Keywords

postoperative analgesiaPainMatcher

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption

    During the first 24 postoperative hours.

Secondary Outcomes (8)

  • 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.

  • Hyperalgesia of peri-scar (in cm²) with a von Frey filament (pressure of 10 grams

    At 2 days after postoperative

  • Questionnaire Douleur de Saint-Antoine (QDSA) ,

    at 3 months, at 6 months

  • +3 more secondary outcomes

Study Arms (3)

Xylocaine

EXPERIMENTAL

intravenous administration

Drug: Xylocaine

Ketamine

EXPERIMENTAL

intravenous administration

Drug: Ketamine

isotonic saline serum

PLACEBO COMPARATOR

isotonic saline serum intravenous administration

Drug: isotonic saline serum intravenous administration

Interventions

XylocaineDRUG

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.

Xylocaine
KetamineDRUG

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.

Ketamine
isotonic saline serum intravenous administrationDRUG
isotonic saline serum

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Surgery: segmental or total colectomy performed by laparoscopy
  • Anesthesia state 1 and 3

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU, Hôpital Claude Huriez

Lille, France

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

LidocaineKetamine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbons

Study Officials

  • Gilles Lebuffe, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2016

First Posted

November 21, 2016

Study Start

January 1, 2011

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

September 12, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)