Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| opioid | Active Comparator | remifentanil 0,15-0,25 mcg/kg/h |
|
| opioid free | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil | Drug | continuous infusion intraop |
| |
| Ketamine |
| Measure | Description | Time Frame |
|---|---|---|
| analgesic consumption | morphine mg by PCA (Patient Controlled Analgesia) | 24 HOURS |
| Measure | Description | Time Frame |
|---|---|---|
| side effects | nausea and vomiting, ileus, itching, shiver, hypotension, bradycardia, sedation | 4 days after surgery |
| Pain Score on the Visual Analog Scale | VAS (Visual Analog Scale) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bugada Dario, MD | Contact | +390521703567 | dariobugada@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Recruiting | Parma | Parma | 43100 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| D007649 | Ketamine |
| D008012 | Lidocaine |
| D003000 | Clonidine |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
randomized double blind trial
Not provided
Not provided
Not provided
| Drug |
bolus 0,5 mg/kg + infusion 0,25 mg/kg/h |
|
| Lidocaine | Drug | lidocaine bolus 1 mg/kg + infusion 1 mg/kg/h |
|
| Clonidine | Drug | clonidine 4 mcg/kg |
|
| 3 months |
| peripheral sensitization | assessment of primary hyperalgesia by Von Frey Filaments at 24 hours | 24 hours |
| central sensitization | assessment of secondary hyperalgesia by pin-prick test at 24 hours | 24 hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |