OFA - Opioid Free Anesthesia (OFA)
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Remifentanil
Ketamine
Lidocaine
Clonidine
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
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
Sites / Locations
- University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
opioid
opioid free
Arm Description
remifentanil 0,15-0,25 mcg/kg/h
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
Outcomes
Primary Outcome Measures
analgesic consumption
morphine mg by PCA (Patient Controlled Analgesia)
Secondary Outcome Measures
side effects
nausea and vomiting, ileus, itching, shiver, hypotension, bradycardia, sedation
Pain Score on the Visual Analog Scale
VAS (Visual Analog Scale)
peripheral sensitization
assessment of primary hyperalgesia by Von Frey Filaments at 24 hours
central sensitization
assessment of secondary hyperalgesia by pin-prick test at 24 hours
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03124082
Brief Title
OFA - Opioid Free Anesthesia
Acronym
OFA
Official Title
Study Protocol "OFA: Opioid-Free Anesthesia".
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 4, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Anticipated)
Study Completion Date
March 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Parma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
randomized double blind trial
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
opioid
Arm Type
Active Comparator
Arm Description
remifentanil 0,15-0,25 mcg/kg/h
Arm Title
opioid free
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Intervention Description
continuous infusion intraop
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
bolus 0,5 mg/kg + infusion 0,25 mg/kg/h
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
lidocaine bolus 1 mg/kg + infusion 1 mg/kg/h
Intervention Type
Drug
Intervention Name(s)
Clonidine
Intervention Description
clonidine 4 mcg/kg
Primary Outcome Measure Information:
Title
analgesic consumption
Description
morphine mg by PCA (Patient Controlled Analgesia)
Time Frame
24 HOURS
Secondary Outcome Measure Information:
Title
side effects
Description
nausea and vomiting, ileus, itching, shiver, hypotension, bradycardia, sedation
Time Frame
4 days after surgery
Title
Pain Score on the Visual Analog Scale
Description
VAS (Visual Analog Scale)
Time Frame
3 months
Title
peripheral sensitization
Description
assessment of primary hyperalgesia by Von Frey Filaments at 24 hours
Time Frame
24 hours
Title
central sensitization
Description
assessment of secondary hyperalgesia by pin-prick test at 24 hours
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bugada Dario, MD
Phone
+390521703567
Email
dariobugada@gmail.com
Facility Information:
Facility Name
University Hospital
City
Parma
ZIP/Postal Code
43100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bugada Dario, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
OFA - Opioid Free Anesthesia
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