None listed
Conditions
Brief summary
Shorter hospital stays and early return to work are the hallmarks of modern day post-operative care of the surgical patient. Using Enhanced Recovery After Surgery (ERAS) protocol, hospital stays can be reduced. Early mobilisation, enteral nutrition and good pain control are the components to improve recovery following surgery. Unfortunatley pain control, especially oral opioids can inhibit bowel function that can cause ileus resulting in reduced mobility, nutrition and increased length of stay in hospital. Targin is a combination of Oxycodone (opioid) and Naloxone (opioid antagonist). The action of Naloxone blocks the opioid receptors around the gastrointestinal tract, BUT does not reduce the efficacy of the oxycodone. This prospective study is to determine if Targin provides excellent analgesia and reduces opioid complications such as ileus on patients undergoing colorectal or upper gastrointestinal surgery.
Interventions
Targin (controlled-release oxycodone hydrochloride / controlled-release naloxone hydrochloride) (Trade names:Targinact, Targiniq and Oxynal) is an oral medication that combines Oxycodone (opioid) and Naloxone (opioid antagonist). The action of Naloxone blocks the opioid receptors around the gastrointestinal tract, BUT does not reduce the efficacy of the oxycodone.
This prospective study is to determine if Targin provides excellent analgesia and reduces opioid complications such as ileus on pa
Targin (controlled-release oxycodone hydrochloride / controlled-release naloxone hydrochloride) (Trade names:Targinact, Targiniq and Oxynal) is an oral medication that combines Oxycodone (opioid) and Naloxone (opioid antagonist). The action of Naloxone blocks the opioid receptors around the gastrointestinal tract, BUT does not reduce the efficacy of the oxycodone. This prospective study is to determine if Targin provides excellent analgesia and reduces opioid complications such as ileus on patients undergoing colorectal or upper gastrointestinal surgery. Targin dosage will depend on opioid requirement from their Patient Controlled Analgesia (PCA) pump or from their Epidural infusion. Commencement of Targin will be at 0800 on day two post-operatively and the PCA or epidural will be discontinued two hours post Targin administration. We expect the dosage will be variable between Targin 10/5 (oxycodone 10mg + naloxone 5mg) twice daily and Targin 20/10 (oxycodone 20mg + naloxone 10mg ) twice daily. The patient will be on Targin for three days post-operatively
Sponsors
Bay of Plenty District Health Board
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Having a planned colorectal or upper gastrointestinal surgery Have good general health as evidenced by medical history. (ASA equal or less than 3) Have normal renal function with Creatinine Clearance > 60ml/min an CK levels within normal limits Be willing to comply with all study procedures and be available for the study duration Women of reproductive potential should not be pregnant or intend becoming pregnant and taking adequate contraception during the treatment period Provide signed and dated informed consent.
Exclusion criteria
Taking antidepressants, anticonvulsants, opioids (incuding Tramadol and Codeine) History of ongoing constipation Have an allergy to any opioids, paracetamol, NSAIDs or Cox 2 inhibitors Diabetes Mellitus Chronic Pain Syndromes Has been treated with another investigational medication or other intervention (within 30 days of commencing on study drug) Can not read and write in the English language Having anything that in the opinion of the investigator, would place the participant at increased risk or preclude the subjects full compliance with or completition of the study
Outcome results
None listed