Clinical trial NCT02786329: Anesthesia and Postoperative Outcome in Colorectal Cancer Patients
Official title: The Influence of Anesthesia on Postoperative Outcome and Complications in Colorectal Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Colorectal Cancer
Keywords: colorectal cancer
TIVA
sevoflurane
lidocaine
Lead sponsor: Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Sponsor class: OTHER
Collaborators: name: Prof. Dr. I. Chiricuta Institute of Oncology
First posted: 2016-06-01
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Survival after TIVA vs sevoflurane anesthesia in patients operated for colorectal cancer
timeFrame: 5 years
measure: Incidence of recurrences:
timeFrame: 5 years
Secondary outcomes:
measure: Morphine consumption during the first 24 postoperative hours
timeFrame: 0- 24 h
measure: 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
timeFrame: 0- 48 h
measure: Resumption of bowel function
timeFrame: 0-72 h
measure: Length of hospital stay
timeFrame: 0-10 days
measure: Postoperative chronic pain
timeFrame: 1 year
measure: Postoperative imflamation
timeFrame: Day 1
measure: Rate of postoperative complications after intravenous lidocaine infusion versus placebo
timeFrame: 0-30 days
measure: Rate of postoperative complications after TIVA versus inhalation anaesthesia
timeFrame: 0-30 days
Other outcomes:
measure: Rate of local anaesthetics systemic toxicity incidence
timeFrame: 0-48 hours
Locations:
city: Cluj-napoca
country: Romania
facility: Clinica ATI, str Croitorilor nr 19-21
state: Cluj
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic Prof Dr Ion Chiricuta
state: Cluj
Study officials:
affiliation: Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca
name: Daniela Ionescu, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca
name: Alexandru Alexa, Assist Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fodale V, D'Arrigo MG, Triolo S, Mondello S, La Torre D. Anesthetic techniques and cancer recurrence after surgery. ScientificWorldJournal. 2014 Feb 6;2014:328513. doi: 10.1155/2014/328513. eCollection 2014.
citation: Heaney A, Buggy DJ. Can anaesthetic and analgesic techniques affect cancer recurrence or metastasis? Br J Anaesth. 2012 Dec;109 Suppl 1:i17-i28. doi: 10.1093/bja/aes421.
citation: Mao L, Lin S, Lin J. The effects of anesthetics on tumor progression. Int J Physiol Pathophysiol Pharmacol. 2013;5(1):1-10. Epub 2013 Mar 8.
citation: Cakmakkaya OS, Kolodzie K, Apfel CC, Pace NL. Anaesthetic techniques for risk of malignant tumour recurrence. Cochrane Database Syst Rev. 2014 Nov 7;2014(11):CD008877. doi: 10.1002/14651858.CD008877.pub2.
citation: Cassinello F, Prieto I, del Olmo M, Rivas S, Strichartz GR. Cancer surgery: how may anesthesia influence outcome? J Clin Anesth. 2015 May;27(3):262-72. doi: 10.1016/j.jclinane.2015.02.007. Epub 2015 Mar 11.
citation: Divatia JV, Ambulkar R. Anesthesia and cancer recurrence: What is the evidence? J Anaesthesiol Clin Pharmacol. 2014 Apr;30(2):147-50. doi: 10.4103/0970-9185.129990. No abstract available.
citation: Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.
citation: McCarthy GC, Megalla SA, Habib AS. Impact of intravenous lidocaine infusion on postoperative analgesia and recovery from surgery: a systematic review of randomized controlled trials. Drugs. 2010 Jun 18;70(9):1149-63. doi: 10.2165/10898560-000000000-00000.
citation: Alexa AL, Tat TF, Ionescu D. The influence of TIVA or inhalation anesthesia with or without intravenous lidocaine on postoperative outcome in colorectal cancer surgery: a study protocol for a prospective clinical study. Trials. 2022 Mar 18;23(1):219. doi: 10.1186/s13063-022-06157-4.