Postoperative Pain
Conditions
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.
Interventions
DRUGRemifentanil
continuous infusion intraop
DRUGKetamine
bolus 0,5 mg/kg + infusion 0,25 mg/kg/h
DRUGLidocaine
lidocaine bolus 1 mg/kg + infusion 1 mg/kg/h
DRUGClonidine
clonidine 4 mcg/kg
Sponsors
University of Parma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
randomized double blind trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| analgesic consumption | 24 HOURS | morphine mg by PCA (Patient Controlled Analgesia) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| side effects | 4 days after surgery | nausea and vomiting, ileus, itching, shiver, hypotension, bradycardia, sedation |
| Pain Score on the Visual Analog Scale | 3 months | VAS (Visual Analog Scale) |
| peripheral sensitization | 24 hours | assessment of primary hyperalgesia by Von Frey Filaments at 24 hours |
| central sensitization | 24 hours | assessment of secondary hyperalgesia by pin-prick test at 24 hours |
Countries
Italy
Contacts
Primary ContactBugada Dario, MD
Outcome results
None listed