OFA - Opioid Free Anesthesia

University of Parma

Status and phase: Unknown; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Clonidine; Drug: Ketamine; Drug: Remifentanil; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03124082

34477

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups

opioid

Active Comparator group

Description:

remifentanil 0,15-0,25 mcg/kg/h

Treatment:

Drug: Remifentanil

opioid free

Experimental group

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

Treatment:

Drug: Ketamine

Drug: Lidocaine

Drug: Clonidine