Anesthesia and Postoperative Outcome in Colorectal Cancer Patients

Early Phase 1

• Conditions: Colorectal Cancer
• Interventions: Drug: Sevoflurane+placebo; Drug: Sevoflurane+lidocaine; Drug: TIVA+placebo; Drug: TIVA+lidocaine

• Registration Number: NCT02786329
• Lead Sponsor: Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

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

Study Timeline

• Study First Submitted: 2016-05-23
• Study First Submitted QC: 2016-05-25
• Study Start: 2016-06
• Study First Posted: 2016-06-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-14
• Last Update Posted: 2022-01-20
• Primary Completion: 2022-08
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sevoflurane+placebo	Sevoflurane+placebo	Sevo-P. Patients allocated to receive Sevoflurane anesthesia without lidocaine infusion (placebo). Intervention: sevoflurane anesthesia +placebo (saline infusion)
Sevoflurane+lidocaine	Sevoflurane+lidocaine	Sevo-L. Patients allocated to receive sevoflurane anesthesia with lidocaine infusion for the first 48 h postoperatively. Intervention: sevoflurane anesthesia+ lidocaine infusion
TIVA+placebo	TIVA+placebo	TIVA-P. Patients allocated to receive TIVA without lidocaine (placebo). Intervention: TIVA+placebo (saline infusion)
TIVA + lidocaine	TIVA+lidocaine	TIVA-L. Patients allocated to receive TIVA (propofol-fentanyl) with lidocaine infusion. Interventions: TIVA+lidocaine

Primary Outcome Measures

Name	Time	Method
Survival after TIVA vs sevoflurane anesthesia in patients operated for colorectal cancer	5 years	Survival at 5 years will be recorded
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.

Secondary Outcome Measures

Name	Time	Method
Resumption of bowel function	0-72 h	Time to first flatus will be registered and compared between groups.
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
Morphine consumption during the first 24 postoperative hours	0- 24 h	Total morphine consumption during the first 24h after surgery will be recorded
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
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.
Length of hospital stay	0-10 days	LOS will be registered and compared between study groups.
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
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.

Trial Locations

Locations (2)

Institutul Oncologic Prof Dr Ion Chiricuta; 🇷🇴 Cluj-Napoca, Cluj, Romania

Clinica ATI, str Croitorilor nr 19-21; 🇷🇴 Cluj-napoca, Cluj, Romania