Study Protocol "OFA: Opioid-Free Anesthesia".
Overview
- Phase
- Phase 4
- Intervention
- Remifentanil
- Conditions
- Postoperative Pain
- Sponsor
- University of Parma
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- analgesic consumption
- Last Updated
- 9 years ago
Overview
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.
Investigators
Massimo Allegri
MD, Assistant Professor
University of Parma
Eligibility Criteria
Inclusion Criteria
- •left hemicolectomy
- •signed informed consent
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
Arms & Interventions
opioid
remifentanil 0,15-0,25 mcg/kg/h
Intervention: Remifentanil
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
Intervention: Ketamine
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
Intervention: Lidocaine
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
Intervention: Clonidine
Outcomes
Primary Outcomes
analgesic consumption
Time Frame: 24 HOURS
morphine mg by PCA (Patient Controlled Analgesia)
Secondary Outcomes
- peripheral sensitization(24 hours)
- Pain Score on the Visual Analog Scale(3 months)
- side effects(4 days after surgery)
- central sensitization(24 hours)