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OFA - Opioid Free Anesthesia (OFA)

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ClinicalTrials.gov Identifier: NCT03124082
Recruitment Status : Unknown
Verified April 2017 by Massimo Allegri, University of Parma.
Recruitment status was:  Recruiting
First Posted : April 21, 2017
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):
Massimo Allegri, University of Parma

Tracking Information
First Submitted Date  ICMJE January 22, 2017
First Posted Date  ICMJE April 21, 2017
Last Update Posted Date April 21, 2017
Actual Study Start Date  ICMJE January 4, 2017
Estimated Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2017)
analgesic consumption [ Time Frame: 24 HOURS ]
morphine mg by PCA (Patient Controlled Analgesia)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2017)
  • side effects [ Time Frame: 4 days after surgery ]
    nausea and vomiting, ileus, itching, shiver, hypotension, bradycardia, sedation
  • Pain Score on the Visual Analog Scale [ Time Frame: 3 months ]
    VAS (Visual Analog Scale)
  • peripheral sensitization [ Time Frame: 24 hours ]
    assessment of primary hyperalgesia by Von Frey Filaments at 24 hours
  • central sensitization [ Time Frame: 24 hours ]
    assessment of secondary hyperalgesia by pin-prick test at 24 hours
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE OFA - Opioid Free Anesthesia
Official Title  ICMJE Study Protocol "OFA: Opioid-Free Anesthesia".
Brief Summary

Opioids have been used for analgesia since many years, but despite potent analgesia they are also associated to side effects, including opioid induced Hyperalgesia (OIH).

OIH in the surgical setting is debated, and may predispose patients to higher analgesic consumption in the preoperative period, and peripheral and central sensitization. The aim of the study is to compare remifentanil-based vs non opioid analgesia (clonidine, lidocaine, ketamine) for intraoperative management of patients undergoing laparoscopic left hemicolectomy, with the hypothesis that non- opiod treated patients will have lower morphine consumption in the first 24 hours after surgery. Peripheral and central hyperalgesia will be tested with Von Frey hairs and pin-prick to evaluate acute CNS (Central Nervous System) sensitization after surgery. Acute and persistent (1 and 3 months) pain will be registered, together with any side effect and parameters of surgical rehabilitation.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
randomized double blind trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • Drug: Remifentanil
    continuous infusion intraop
  • Drug: Ketamine
    bolus 0,5 mg/kg + infusion 0,25 mg/kg/h
  • Drug: Lidocaine
    lidocaine bolus 1 mg/kg + infusion 1 mg/kg/h
  • Drug: Clonidine
    clonidine 4 mcg/kg
Study Arms  ICMJE
  • Active Comparator: opioid
    remifentanil 0,15-0,25 mcg/kg/h
    Intervention: Drug: Remifentanil
  • Experimental: opioid free
    ketamine bolus 0,5 mg/kg + infusion 0,25 mg/kg/h lidocaine bolus 1 mg/kg + infusion 1 mg/kg/h clonidine 4 mcg/kg
    Interventions:
    • Drug: Ketamine
    • Drug: Lidocaine
    • Drug: Clonidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 18, 2017)
64
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2018
Estimated Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • left hemicolectomy
  • signed informed consent
  • >18 ys

Exclusion Criteria:

  • >90 ys <18 ys
  • no consent
  • pregnancy
  • psychiatric disease
  • cardiac failure, aortic or mitral valve severe stenosis
  • kidney or hepatic failure
  • atrio-ventricular type II block
  • immunodepression
  • emergency surgery
  • ICU admittance
  • drug or alcohol abuse
  • chronic pain
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03124082
Other Study ID Numbers  ICMJE 34477
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Massimo Allegri, University of Parma
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Parma
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Parma
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP