OFA - Opioid Free Anesthesia

Postoperative Pain Clinical Trial

— OFA  

Official title:

Study Protocol "OFA: Opioid-Free Anesthesia".

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03124082
• Other study ID #: 34477
• Status: Recruiting
• Phase: Phase 4
• First received: January 22, 2017
• Last updated: April 18, 2017
• Start date: January 4, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: April 2017
• Source: University of Parma
• Contact: Bugada Dario, MD
• Phone: +390521703567
• Email: dariobugada[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: March 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Remifentanil
continuous infusion intraop
• Ketamine
bolus 0,5 mg/kg + infusion 0,25 mg/kg/h
• Lidocaine
lidocaine bolus 1 mg/kg + infusion 1 mg/kg/h
• Clonidine
clonidine 4 mcg/kg

Locations

Country	Name	City	State
Italy	University Hospital	Parma

Sponsors (1)

Lead Sponsor	Collaborator
University of Parma

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	analgesic consumption	morphine mg by PCA (Patient Controlled Analgesia)	24 HOURS
Secondary	side effects	nausea and vomiting, ileus, itching, shiver, hypotension, bradycardia, sedation	4 days after surgery
Secondary	Pain Score on the Visual Analog Scale	VAS (Visual Analog Scale)	3 months
Secondary	peripheral sensitization	assessment of primary hyperalgesia by Von Frey Filaments at 24 hours	24 hours
Secondary	central sensitization	assessment of secondary hyperalgesia by pin-prick test at 24 hours	24 hours