Colorectal Cancer
Conditions
Keywords
colorectal cancer, TIVA, sevoflurane, lidocaine
Brief summary
Study aims to compare the influence of TIVA and sevoflurane anesthesia with or without lidocaine on postoperative short and long term outcome in patients with colorectal cancer undergoing surgery. As short term endpoints postoperative pain and opioid consumption, resumption of bowel function, PONV, LOS will be registered. Long term outcome parameters include: the incidence of chronic pain, 1 and 5 years cancer recurrences incidence and mortality.
Detailed description
Main goals 1. Comparative evaluation of the incidence of recurrences after TIVA vs sevoflurane anesthesia 2. Evaluation of the effect of lidocaine infusion associated with TIVA/sevoflurane on the incidence of chronic pain and of cancer recurrences and survival. Secondary objectives 1. Evaluation of the influence of lidocaine on postoperative outcome in patients with colorectal cancer 2. Evaluation of the influence of lidocaine on postoperative inflammatory response 3. Evaluation of the influence of lidocaine on the incidence and severity of postoperative pain and outcome in patients with colorectal cancer
Interventions
DRUGTIVA+lidocaine
Patients will be subjected to total intravenous anesthesia with propofol-fentanyl+i.v. lidocaine infusion for the first 48 h postoperatively
DRUGSevoflurane+lidocaine
Patients will be subjected to anesthesia with sevoflurane- fentanyl + lidocaine infusion for the first 48 h postoperatively.
DRUGTIVA+placebo
Patients will be subjected to TIVA with propofol-fentanyl + saline infusion for the first 48 h postoperatively
DRUGSevoflurane+placebo
Patients will be subjected to anesthesia with sevoflurane-fentanyl + saline infusion for the first 48 h postoperatively
Sponsors
Prof. Dr. I. Chiricuta Institute of Oncology
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Elective surgery
Exclusion criteria
* • persistent chronic pain * chronic medication that may interfere with pain: antiepileptics, NSAID, corticoids * Contraindications for any of the study medications * Significant psychiatric disorders (Axa I) (major depression, bipolar disorders, schizophrenia, etc.) * Significant hepatic (ALAT and/or ASAT \> 2 normal values) or renal (plasma creatinine \> 2 mg/dl) disorders * Convulsive disorders requiring medication during the last 2 years * Planned regional analgesia/anesthesia (spinal or epidural) * Corticoid dependent asthma * Autoimmune disorders * Anti-arrhythmic medication (verapamil, propafenone, amiodarone) that may interfere with lidocaine's anti-arrhythmic effects * Refusal for study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of recurrences: | 5 years | The incidence of recurrences will be registered annually and reported from the first year to 5 years respectively in all 4 groups of patients. |
| Survival after TIVA vs sevoflurane anesthesia in patients operated for colorectal cancer | 5 years | Survival at 5 years will be recorded |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of postoperative pain - verbal response pain (VRPS) score 1-10, (1=no pain, 10=worst pain) in recovery room and during the first 48 hrs postoperatively. Target verbal response pain score ≤3 | 0- 48 h | The severity of postoperative pain will be recorded along with morphine consumption.Pain intensity will be followed during the first 48 h postoperatively. |
| Resumption of bowel function | 0-72 h | Time to first flatus will be registered and compared between groups. |
| Length of hospital stay | 0-10 days | LOS will be registered and compared between study groups. |
| Postoperative imflamation | Day 1 | Evaluation of the influence of lidocaine on 24-hour postoperative inflammatory response; All patients will have leukocytes count and c protein reactive (PCR) so an analysis can be made. |
| Rate of postoperative complications after intravenous lidocaine infusion versus placebo | 0-30 days | Monitoring the incidence of some common perioperative complications: pulmonary embolism, pulmonary edema, acute kidney injury, anastomosis leak, myocardial infarction, stroke, pneumonia |
| Rate of postoperative complications after TIVA versus inhalation anaesthesia | 0-30 days | Monitoring the incidence of some common perioperative complications: pulmonary embolism, pulmonary edema, acute kidney injury, anastomosis leak, myocardial infarction, stroke, pneumonia |
| Postoperative chronic pain | 1 year | Chronic pain at 6 month and 1 year respectively will be assessed with McGill questionnaire by telephone interview. Scores range from 0 (no pain) to 78 (severe pain), patients with high scores need to seek medical advice |
| Morphine consumption during the first 24 postoperative hours | 0- 24 h | Total morphine consumption during the first 24h after surgery will be recorded |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of local anaesthetics systemic toxicity incidence | 0-48 hours | An investigator will note any signs of local anaesthetics systemic toxicity at the bed site of patient |
Countries
Romania
Contacts
Primary ContactDaniela IONESCU, Prof
Backup ContactAlexandru Alexa, Assist Prof
Outcome results
None listed