Effect of Lignocaine Infusion in Colorectal Cancer Patient Immune Cells

Phase 3

Completed

• Conditions: colon cancer; Cancer - Bowel - Back passage (rectum) or large bowel (colon); Inflammatory and Immune System - Other inflammatory or immune system disorders; Anaesthesiology - Pain management; Surgery - Other surgery

• Registration Number: ACTRN12618000754246
• Lead Sponsor: Hunter New England Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-04
• Study Completion: 2022-11-04
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

All patients with colorectal cancer undergoing elective or semi-elective laparoscopic colon resection at the John Hunter Hospital and Newcastle Private Hospital

Exclusion Criteria

a. are under 18 years of age, or
b. refuse or are unable to give written informed consent to participate in the study, or
c. have had previous abdominal surgery where there is a significant chance of the procedure not being able to be completed in a laparoscopic manner, based in the clinical judgement of the operating surgeon, or
d. have severe renal impairment or
e. receive an epidural, spinal or other neuroaxial anaesthetic as determined by the Anaesthetist on day of surgery, or
f. Have a planned stoma formation or
a. Have received neoadjuvant chemo-radiotherapy or have been on immunosuppressive agents in the preceding 8 weeks including glucocorticoids (not including inhaled steroids), antimetabolites, cytostatics (eg platinum compounds), antimetabolites (eg methotrexate, mercaptopurine, azathioprine, 5FU, anthracyclines, cytotoxic antibiotics eg bleomycin) , TNF bindng proteins (eg infliximab), drugs acting on immunophilins or
b. Have known stage 4 colorectal cancer disease
c. have known immunological disease including leukaemia or
d. have known allergy or adverse reaction to lignocaine or opioid drugs or
e. pregnant or lactating or
f. have a history of arrhythmia or long QT syndrome associated with the drugs used in this trial, or
g. Are taking regular opiate narcotics pre-operatively

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The composite primary outcome will be the difference in baseline natural killer cell function (cytotoxic and secretory) as measured by flow cytometry and phorbol 12-myristate 13-acetate (PMA) stimulation testing.[ 0 (baseline prior to any administration of medication for procedure), end of hour 1 in operating theatre and hour 2 in recovery, 24, 48 and 72 hours.<br><br>]