Anesthesia and Postoperative Outcome in Colorectal Cancer Patients

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02786329
• Other study ID #: 53/14.03.2016
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 2016
• Est. completion date: December 2022

Study information

• Verified date: January 2022
• Source: Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
• Contact: Daniela IONESCU, Prof
• Phone: +40744771209
• Email: dionescuati[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• TIVA+lidocaine
Patients will be subjected to total intravenous anesthesia with propofol-fentanyl+i.v. lidocaine infusion for the first 48 h postoperatively
• Sevoflurane+lidocaine
Patients will be subjected to anesthesia with sevoflurane- fentanyl + lidocaine infusion for the first 48 h postoperatively.
• TIVA+placebo
Patients will be subjected to TIVA with propofol-fentanyl + saline infusion for the first 48 h postoperatively
• Sevoflurane+placebo
Patients will be subjected to anesthesia with sevoflurane-fentanyl + saline infusion for the first 48 h postoperatively

Locations

Country	Name	City	State
Romania	Clinica ATI, str Croitorilor nr 19-21	Cluj-napoca	Cluj
Romania	Institutul Oncologic Prof Dr Ion Chiricuta	Cluj-Napoca	Cluj

Sponsors (2)

Lead Sponsor	Collaborator
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor	Prof. Dr. I. Chiricuta Institute of Oncology

Country where clinical trial is conducted

Romania, 

References & Publications (8)

Cakmakkaya OS, Kolodzie K, Apfel CC, Pace NL. Anaesthetic techniques for risk of malignant tumour recurrence. Cochrane Database Syst Rev. 2014 Nov 7;(11):CD008877. doi: 10.1002/14651858.CD008877.pub2. Review. — View 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. Review. — View 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. — View 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. Review. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of local anaesthetics systemic toxicity incidence	An investigator will note any signs of local anaesthetics systemic toxicity at the bed site of patient	0-48 hours
Primary	Survival after TIVA vs sevoflurane anesthesia in patients operated for colorectal cancer	Survival at 5 years will be recorded	5 years
Primary	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	Morphine consumption during the first 24 postoperative hours	Total morphine consumption during the first 24h after surgery will be recorded	0- 24 h
Secondary	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
Secondary	Resumption of bowel function	Time to first flatus will be registered and compared between groups.	0-72 h
Secondary	Length of hospital stay	LOS will be registered and compared between study groups.	0-10 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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