OFA - Opioid Free Anesthesia

Phase 4

• Conditions: Postoperative Pain
• Interventions: Drug: Ketamine; Drug: Remifentanil; Drug: Lidocaine; Drug: Clonidine

• Registration Number: NCT03124082
• Lead Sponsor: University of Parma

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 available

Study Timeline

• Study Start: 2017-01-04
• Study First Submitted: 2017-01-22
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-18
• Last Update Submitted: 2017-04-18
• Study First Posted: 2017-04-21
• Last Update Posted: 2017-04-21
• Primary Completion: 2017-12-31
• Study Completion: 2018-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
opioid free	Ketamine	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
opioid	Remifentanil	remifentanil 0,15-0,25 mcg/kg/h
opioid free	Clonidine	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
opioid free	Lidocaine	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

Primary Outcome Measures

Name	Time	Method
analgesic consumption	24 HOURS	morphine mg by PCA (Patient Controlled Analgesia)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital; 🇮🇹 Parma, Italy