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Trial registered on ANZCTR


Trial ID
ACTRN12613001197729
Ethics application status
Approved
Date submitted
16/10/2013
Date registered
30/10/2013
Date last updated
30/10/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Targin provide effective analgesia while reducing ileus in postoperative colorectal and upper gastrointestinal surgery?
Scientific title
Does Targin provide effective analgesia while reducing ileus in postoperative colorectal and upper gastrointestinal surgery.
Secondary ID [1] 283405 0
nil
Universal Trial Number (UTN)
U1111-1139-773
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Analgesia for post colorectal and upper gastrointestinal surgery 290313 0
Condition category
Condition code
Anaesthesiology 290707 290707 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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

Intervention code [1] 288128 0
Treatment: Drugs
Comparator / control treatment
This is a single site prospective cohort study on 45 participants, but with the belief that we will go onto a blinded study in the future. We currently have the first 50 Enhanced Recovery After Surgery (ERAS) (1) patients with detailed side-effects and pain scores, who have either had Oxycontin or Fentanyl Patches.
These first 50 ERAS patients time span was from 03 September 2012 to 21 February 2013. All 50 ERAS patients notes, recordings, side-effects, complications and pain relief were reviewed and recorded by the surgical team from the Department of Surgery, Bay of Plenty District health Board, who are responsible for the ERAS project and then reviewed again by the Clinical Pain Service.
Therefore, we will be doing a initial comparison for this study to add strength of the research and provide proof that Targin does or does not provide effective analgesia while reducing ileus.

(1) Varadhan, K.K, Lobo, D.N and Ljungqvist O. Enhanced recovery after surgery: The future of improving surgical care. Crit Car Clin 26 (2010) 527-547
Control group
Historical

Outcomes
Primary outcome [1] 290714 0
Reducing post-operative ileus with oral opioid analgesia

Clinical Pain Service visit twice a day from post-operative day one to day 5 and the following questions asked and
Pain Scores at rest and on movement
Bowel sounds, Passed flatus,bowel movement, nausea, vomiting and other adverse effects.
All analgesics and anti-emetics recorded.
All Vital signs recorded.
Patient will also have a five day diary to complete. These are the same questions that the CPS ask but we believe it is important to to reduce placebo effect.
Timepoint [1] 290714 0
Five days
Secondary outcome [1] 305083 0
Time to oral nutrition

Recorded in Patient diary
Timepoint [1] 305083 0
Five days
Secondary outcome [2] 305102 0
Time to mobilisation

Recorded in patient diary
Timepoint [2] 305102 0
Five days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5518 0
New Zealand
State/province [1] 5518 0
Tauranga

Funding & Sponsors
Funding source category [1] 288128 0
Other
Name [1] 288128 0
Bay of Plenty Medical Research Trust
Address [1] 288128 0
P.O.Box 752
Tauranga 3140
Country [1] 288128 0
New Zealand
Primary sponsor type
Hospital
Name
Bay of Plenty District Health Board
Address
Private Bag 12024
Tauranga 3143
Country
New Zealand
Secondary sponsor category [1] 286846 0
None
Name [1] 286846 0
Address [1] 286846 0
Country [1] 286846 0

Ethics approval
Ethics application status
Approved

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43678 0
Mr Jeremy Rossaak
Address 43678 0
Department of Surgery
Bay of Plenty District Health Board
Private Bag 12024
Tauranga 3143
Country 43678 0
New Zealand
Phone 43678 0
+6475798000
Fax 43678 0
Email 43678 0
jeremy.rossaak@bopdhb.govt.nz
Contact person for public queries
Name 43679 0
Mr Scott Jones
Address 43679 0
Department of Anaesthesia and Pain Management
Bay of Plenty District Health Board
Private Bag 12024
Tauranga 3143
Country 43679 0
New Zealand
Phone 43679 0
+64212730486
Fax 43679 0
Email 43679 0
scott.jones@bopdhb.govt.nz
Contact person for scientific queries
Name 43680 0
Mr Jeremy Rossaak
Address 43680 0
Department of Surgery
Bay of Plenty District Health Board
Private bag 12024
Tauranga 3143
Country 43680 0
New Zealand
Phone 43680 0
+6475798000
Fax 43680 0
Email 43680 0
jeremy.rossaak@bopdhb.govt.nz