None listed
Conditions
Brief summary
The study aims to find out if giving local anaesthetic (a medication that numbs an area of the body) into the bloodstream and via small plastic tube placed during surgery into the abdomen will improve part of the immune system in patients undergoing surgery for colorectal cancer. Who is it for? You may be eligible to join this study if you aged 18 years or more and are scheduled to undergo a keyhole operation (laparoscopic surgery) for colorectal cancer to remove a section of the bowel (also known as colon). Study details Participants in this study will be randomly allocated (by chance) into one of two groups. Participants in one group will receive a local anaesthetic drug called Lignocaine infused directly into the bloodstream and also into the abdomen using a small plastic tube placed during surgery. Lignocaine is very commonly used to numb areas of skin or muscle before or during an operation. Importantly it has also been shown to help the natural killer cells (NKC) to destroy cancer cells. NKCs are a special type of white blood cell which recognises and destroys cancer cells. Participants in the other group will instead be given a placebo (salty water). Participants will not know which group they are in. All participants will be monitored for up to 30 days post-surgery in order to evaluate safety and also to see if the natural killer cells in the blood work better after lignocaine is used.
Interventions
Prior to surgery commencing, participants will be randomised to Treatment S or Treatment R. At commencement of anaesthesia the study drug will commence as an intravenous infusion of a 1% lignocaine infusion or placebo at a dose of 1.5mg per kg capped at a maximum weight of 100kg. This infusion will continue into recovery for 1 hour, then will be changed to an infusion of same rate via a catheter placed during the operative procedure into a muscular neurovascular plane in the abdominal wall. The
Prior to surgery commencing, participants will be randomised to Treatment S or Treatment R. At commencement of anaesthesia the study drug will commence as an intravenous infusion of a 1% lignocaine infusion or placebo at a dose of 1.5mg per kg capped at a maximum weight of 100kg. This infusion will continue into recovery for 1 hour, then will be changed to an infusion of same rate via a catheter placed during the operative procedure into a muscular neurovascular plane in the abdominal wall. The infusion will continue for a maximum of 3 days post-operatively, there is no minumum duration for infusion. The specific duration will be determined by the post-operative recovery of the individual patient. The study drug will be prescribed on standard continous nerve block prescription charts which will be used to confirm compliance to study intervention.
Sponsors
Hunter New England Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed