Opioid Consumption, Postoperative Pain
Conditions
Keywords
Lidocaine, Postoperative Pain, Opioid consumption, Laparoscopic cholecystectomy
Brief summary
The purpose of this study is to evaluate how effective is the intraoperative use of lidocaine to attenuate postoperative pain and opioids consumption after laparoscopic cholecystectomy
Detailed description
Acute postoperative pain may predict the development of chronic pain.Recently, the analgesic effect of lidocaine, as a part of a multimodal analgesia, has been evaluated in many studies. They have shown that lidocaine may have a role in the postoperative pain management, as an adjunct. Acute postoperative pain after laparoscopic cholecystectomy is complex in nature. Postoperative pain is the main complaint and the primary reason for delay discharge after laparoscopic cholecystectomy.The study includes patients undergoing laparoscopic cholecystectomy.
Interventions
DRUGLidocaine
Intraoperative administration of lidocaine
DRUGPlacebo
Intraoperative administration of normal saline
Sponsors
Larissa University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ASA physical status I-II * Age ≥ 18 years old * BMI ≤ 35
Exclusion criteria
* Allergy in local anesthetics * History of liver, kidney or heart failure * Existence of chronic pain history or daily analgesics * Psychiatric disorders * Inability to understand pain assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative opioid consumption | 24 hours after the procedure | The total dose of tramadol is calculated as mg and administered intravenously. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Nausea and Vomiting | 24 hours | The percentage of patients who had nausea and vomiting during the first 24 hours |
| Incidence of sedation and respiratory depression | 24 hours | The percentage of patients who had sedation and respiratory depression during the first 24 hours |
| Incidence of shoulder pain | 24 hours | The percentage of patients who had shoulder pain during the first24 hours |
| Incidence of headache and dizziness | 24 hours | The percentage of patients who had headache and dizziness during the first 24 hours |
| Postoperative pain | Departure of the patient from the recovery room (0hrs) | Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain) |
| Change from Baseline Heart Rate | Intraoperative | Bradycardia, tachycardia during the procedure |
| Change in depth of anesthesia | Intraoperative | Maintenance of Bispectral index (BIS) values of 40 to 50 |
| Side effect related to administration of lidocaine | 24 hours | The percentage of patients who had tremor, dizziness, dysarthria, agitation, hallucinations and drowsiness during the first 24 hours |
| Change from baseline Mean Blood Pressure | Intraoperative | Non-invasive blood pressure measurement by using sphygmomanometer cuff |
Countries
Greece
Outcome results
None listed