Anesthesia and Postoperative Outcome in Colorectal Cancer Patients

Study Overview
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Brief Summary
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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
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Main goals Comparative evaluation of the incidence of recurrences after TIVA vs sevoflurane anesthesia 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 Evaluation of the influence of lidocaine on postoperative outcome in patients with colorectal cancer Evaluation of the influence of lidocaine on postoperative inflammatory response Evaluation of the influence of lidocaine on the incidence and severity of postoperative pain and outcome in patients with colorectal cancer

Official Title
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The Influence of Anesthesia on Postoperative Outcome and Complications in Colorectal Cancer Patients

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: TIVA+lidocaine
* Drug: Sevoflurane+lidocaine
* Drug: TIVA+placebo
* Drug: Sevoflurane+placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TIVA + lidocaine<br>TIVA-L. Patients allocated to receive TIVA (propofol-fentanyl) with lidocaine infusion. Interventions: TIVA+lidocaine | Drug: TIVA+lidocaine<br>* Patients will be subjected to total intravenous anesthesia with propofol-fentanyl+i.v. lidocaine infusion for the first 48 h postoperatively<br>* Other names: TIVA-L;|
| Placebo Comparator: TIVA+placebo<br>TIVA-P. Patients allocated to receive TIVA without lidocaine (placebo). Intervention: TIVA+placebo (saline infusion) | Drug: TIVA+placebo<br>* Patients will be subjected to TIVA with propofol-fentanyl + saline infusion for the first 48 h postoperatively<br>* Other names: TIVA-P;|
| Placebo Comparator: Sevoflurane+placebo<br>Sevo-P. Patients allocated to receive Sevoflurane anesthesia without lidocaine infusion (placebo). Intervention: sevoflurane anesthesia +placebo (saline infusion) | Drug: Sevoflurane+placebo<br>* Patients will be subjected to anesthesia with sevoflurane-fentanyl + saline infusion for the first 48 h postoperatively<br>* Other names: Sevo-P;|
| Active Comparator: Sevoflurane+lidocaine<br>Sevo-L. Patients allocated to receive sevoflurane anesthesia with lidocaine infusion for the first 48 h postoperatively. Intervention: sevoflurane anesthesia+ lidocaine infusion | Drug: Sevoflurane+lidocaine<br>* Patients will be subjected to anesthesia with sevoflurane- fentanyl + lidocaine infusion for the first 48 h postoperatively.<br>* Other names: Sevo-L;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival after TIVA vs sevoflurane anesthesia in patients operated for colorectal cancer | Survival at 5 years will be recorded | 5 years | 
| Incidence of recurrences: | The incidence of recurrences will be registered annually and reported from the first year to 5 years respectively in all 4 groups of patients. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption during the first 24 postoperative hours | Total morphine consumption during the first 24h after surgery will be recorded | 0- 24 h | 
| 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 | The severity of postoperative pain will be recorded along with morphine consumption.Pain intensity will be followed during the first 48 h postoperatively. | 0- 48 h | 
| Resumption of bowel function | Time to first flatus will be registered and compared between groups. | 0-72 h | 
| Length of hospital stay | LOS will be registered and compared between study groups. | 0-10 days | 
| Postoperative chronic pain | 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 | 1 year | 
| Postoperative imflamation | 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. | Day 1 | 
| Rate of postoperative complications after intravenous lidocaine infusion versus placebo | Monitoring the incidence of some common perioperative complications: pulmonary embolism, pulmonary edema, acute kidney injury, anastomosis leak, myocardial infarction, stroke, pneumonia | 0-30 days | 
| Rate of postoperative complications after TIVA versus inhalation anaesthesia | Monitoring the incidence of some common perioperative complications: pulmonary embolism, pulmonary edema, acute kidney injury, anastomosis leak, myocardial infarction, stroke, pneumonia | 0-30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TIVA, colorectal cancer, sevoflurane, lidocaine