OFA - Opioid Free Anesthesia (OFA)

Study Protocol "OFA: Opioid-Free Anesthesia".

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Remifentanil; Drug: Ketamine; Drug: Lidocaine; Drug: Clonidine

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Bugada Dario, MD; Phone Number: +390521703567; Email: dariobugada@gmail.com

Study Locations

• Italy
  • Parma, Italy, 43100
    • Recruiting
    • University Hospital
    • Contact: Bugada Dario, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: opioid; remifentanil 0,15-0,25 mcg/kg/h	Drug: Remifentanil; continuous infusion intraop
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
analgesic consumption	morphine mg by PCA (Patient Controlled Analgesia)	24 HOURS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
side effects	nausea and vomiting, ileus, itching, shiver, hypotension, bradycardia, sedation	4 days after surgery
Pain Score on the Visual Analog Scale	VAS (Visual Analog Scale)	3 months
peripheral sensitization	assessment of primary hyperalgesia by Von Frey Filaments at 24 hours	24 hours
central sensitization	assessment of secondary hyperalgesia by pin-prick test at 24 hours	24 hours

Collaborators and Investigators

• Sponsor: University of Parma

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2017
• Primary Completion (Anticipated): December 31, 2017
• Study Completion (Anticipated): March 31, 2018

Study Registration Dates

• First Submitted: January 22, 2017
• First Submitted That Met QC Criteria: April 18, 2017
• First Posted (Actual): April 21, 2017

Study Record Updates

• Last Update Posted (Actual): April 21, 2017
• Last Update Submitted That Met QC Criteria: April 18, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Sympatholytics; Ketamine; Remifentanil; Lidocaine; Clonidine
• Other Study ID Numbers: 34477

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No