Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001011774
Ethics application status
Approved
Date submitted
17/08/2013
Date registered
11/09/2013
Date last updated
11/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing oral and intravenous patient controlled analgesia for post caesarean section pain relief: A randomised controlled trial.
Scientific title
Comparing oral and intravenous patient controlled analgesia for post caesarean section pain relief: A randomised controlled trial.
Secondary ID [1] 282787 0
nil
Universal Trial Number (UTN)
Trial acronym
CROPP: Controlled released Oxycodone for post ceasarean section pain relief.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain post ceasarean section 289554 0
Condition category
Condition code
Anaesthesiology 289882 289882 0 0
Pain management
Reproductive Health and Childbirth 290311 290311 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral opioid analgesia post ceasarean section in the form of Controlled release Oxycodone 20mg twice daily for a maximum of 4 doses over a period of 48 hours, with Oxycodone immediate release 10 to 15mg orally at a minimum interval of 3 hours between doses as needed over a period of 48 hours post partum.

Drug charts are monitored to monitor drug use over the mentioned period.

Both test and control group will receive additional analgesia in the form of Paracetamol 1 gram oral, Ibuprofen 400mg regularly. Tramadol 50 - 100mg IV or oral is available as a rescue medication in case of poor pain control despite maximum use of the trial regimen.

The anaesthetic for the caesarean section is standardised to a single shot spinal anaesthetic with a combination of Heavy Bupivavaine 0.5% and Fentanyl 15 - 25mcg, Paracetamol 1g and Diclofenac 100mg PR
Intervention code [1] 287467 0
Treatment: Drugs
Comparator / control treatment
Opioid Post caesarean section pain relief in the form of intravenous morphine patient controlled analgesia.

The regimen is as follows: Morphine 1 mg per ml in 100ml Saline (0.9%). Every successful push of the button will administer a dose of 1 ml (1mg) of morphine followed by a lockout of 5 minutes and no hourly limit.

Patient controlled devices are monitored daily for 48 hours to note the doses of morphine being used.
Both test and control group will receive additional analgesia in the form of Paracetamol 1 gram oral, Ibuprofen 400mg regularly. Tramadol 50 - 100mg IV or oral was available as a rescue medication in case of poor pain control despite maximum use of the trial regimen.

The anaesthetic for the caesarean section is standardised to a single shot spinal anaesthetic with a combination of Heavy Bupivavaine 0.5% and Fentanyl 15 - 25 mcg, Paracetamol 1 g and Diclofenac 100 mg PR
Control group
Active

Outcomes
Primary outcome [1] 289942 0
Comparing the pain scores, averaged per 24 hours for a 48 hours, between the test (Oxydone) and control (Morphine) group. Patients are asked to use a numerical pain score ranging from 0 (no pain) to 10 (worst pain imaginable) to rate their pain. A pain score difference of 2 has been chosen to correlate with clinical significance.
Timepoint [1] 289942 0
Observations are done 6 hourly over a period of 48 hours, Patient’s sleep is not interrupted for observations. Pain scores done on a 6 hourly basis are averaged using an area under the curve of a pain score time diagram to process the multiple observations from a single patient into a single numerical value for every 24 hours for a period of 48 hours.
Secondary outcome [1] 303621 0
Comparing the incidence of pruritis between the control (morphine) and the test (Oxycodone) group. The outcome is assesesed by the patient subjective reporting either the presence or absence of of pruritis. Nursing staff note the presence on an observations sheet.
Timepoint [1] 303621 0
Observations are done 6 hourly over a period of 48 hours, Patient’s sleep is not interrupted for observations.
Secondary outcome [2] 303622 0
Nausea: incidence and severity (based on antiemtic use) comparing the control (morphine) and the test (Oxycodone) group. The outcome is assesesed by the patient subjective reporting either the presence or absence of of Nausea. Nursing staff note the presence on an observations sheet. The severity scale used is mild: Nausea present, no treatment required, moderate: Nausea present, treatment required, Severe: Vomiting
Timepoint [2] 303622 0
Observations are done 6 hourly over a period of 48 hours, Patient’s sleep is not interrupted for observations.
Secondary outcome [3] 303623 0
Comparing the incidence of sedation between the control (morphine) and the test (Oxycodone) group. Using sedation score from 1 to 5: 1 no sedation, 2 sedation present, but not problematic for patient, 3 sedation present enough to be a problem for the patient, 4 (Clinical significant sedation): patient difficult to wake, 5 coma. The outcome is assesesed by the patient subjective reporting either the presence or absence of of sedation and by the clinical assesment by the bursing staff. Nursing staff note the level of sedation on an observations sheet.
Timepoint [3] 303623 0
Observations are done 6 hourly over a period of 48 hours, Patient’s sleep is not interrupted for observations. '
Secondary outcome [4] 303624 0
Patient satisfaction is compared between the test and control group. Using a questionnaire which the patient has to complete: How would you rate your analgesia: 1 very bad, 2 bad, 3 reasonable, 4 good, 5 very good. Will they use it again and will they recommend it to a friend?
Timepoint [4] 303624 0
Once off Questionnaire the morning of the second day after caesarean section.
Secondary outcome [5] 303625 0
The incidence of a change in protocol required for patient or clinical reasons. The drug chart adn clincal notes are reviewed to identify a change to the randomised protocol. All efforts are made to identify the reason for the change, by reviewing chart, talking to patient, nursing and medical staff. A short summary of the events leading to the change in protocol is made on the assesment form.
Timepoint [5] 303625 0
48 hours post caesarean section
Secondary outcome [6] 303626 0
Use of rescue analgesia medication above true trial protocol. This is assesed by reviewing the drug charts and noting the times and doses resque medication has been accessed on the as needed part of the chart.
Timepoint [6] 303626 0
Every 24 hours for 2 days post caesarean section

Eligibility
Key inclusion criteria
Elective ceasarean section patients
Spinal anaesthetic for caesarean section
No contraindication to use trial medication
Able to consent
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
General anaesthesia
Contraindication to trial medication
Unable to consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Contact is made with patients at the pre anaesthetic clinic prior to their Caesarean section. Patients are screened for exclusion criteria and are given verbal and written information about the trial. After informed consent patients are randomly assigned to either test or control group.

The randomisation process is as follows: a randomisation list is produced using appropriate software. Participants are allocated a sequential number from 1 to 120. The numbers corresponds to randomly assigned test or control group. The recruitment officer is blinded to which group the patient will be randomised to at time of consent. The key to randomisation is held by a staff member not involved in recruitment.

Following randomisation the participant is given written and verbal information relating to their analgesic regimen .
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants are assigned a number from 1 to 120. This numbering process is sequential. The numbers correspond to a randomly allocated test or control analgesic regimen.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The null hypothesis is that there is no difference between pain scores between the 2 groups. A pain score of 2 is clinically significant.

Pain scores are in the form of a non parametric score from 0 to 10. Where 0 corresponds to no pain and 10 the most severe pain imaginable.

Please find the calculation of the sample size underneath:

Goal: Find the sample size
Tests: t-test for two independent samples


Results:

Parameters Results
Power 0.800
alpha 0.05
Mean (Group 1) 4.1
Mean (Group 2) 2.9
Std. deviation (Group 1) 2.5
Std. deviation (Group 2) 1.9
Sample size 1 55
Sample size 2 55
Power (obtained) 0.802


Test interpretation:
H0: The difference between the means is equal to 0.
Ha: The difference between the means is different to 0.
The risk to not reject the null hypothesis H0 while it is false is 0.2.
For the given parameters, for an alpha of 0.05, the necessary sample size to reach a power of 0.8 is 55 observations.

The calculation was conducted using XLSTAT

An extra 10% was added to the sample size to account for patient drop outs.

Leaving the number of patients to be recruited 121.

Dealing with the problem of multiple observations for the same patient: The pain scores for an individual patient for a period of 24 hours are averaged using the area under the curve of the pain time graph for that patient. It is repeated for the first and second 24 hours. The first 24 hours will be used to calculate the primary outcome.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/12/2010
Actual
20/12/2010
Date of last participant enrolment
Anticipated
16/11/2012
Actual
16/11/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1442 0
Toowoomba Hospital - Toowoomba
Recruitment postcode(s) [1] 7273 0
4350 - Toowoomba City

Funding & Sponsors
Funding source category [1] 287783 0
Hospital
Name [1] 287783 0
Toowoomba Hospital Foundation
Country [1] 287783 0
Australia
Primary sponsor type
Individual
Name
Dr. Petrus J Kotze
Address
Toowoomba Hospital

Pechey Street
Toowoomba, QLD 4350
Country
Australia
Secondary sponsor category [1] 286512 0
None
Name [1] 286512 0
Address [1] 286512 0
Country [1] 286512 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289733 0
The Toowoomba & Darlings Downs Health District HREC
Ethics committee address [1] 289733 0
Toowoomba Hospital
Pechey Street
Toowoomba, QLD 4350
Ethics committee country [1] 289733 0
Australia
Date submitted for ethics approval [1] 289733 0
01/07/2010
Approval date [1] 289733 0
16/11/2010
Ethics approval number [1] 289733 0
HREC/10QTDD/29

Summary
Brief summary
The CROPP trial evaluates the hypothesis that 2 drug regimens are equally effective to deliver pain relief after a caesarean section. The drug which we are testing is called Oxycodone. We deliver the Oxycodone to participants in the test group in controlled release form on a regular basis over 2 days. The participant is also able to request immediate release Oxycodone for the breakthrough pain. These tablets are swallowed with water. In the control group the participants will receive Morphine into a vein each time a computer called a Patient controlled analgesic device is activated by the participant. The primary aim of the research project is to see if the 2 types of drugs have the same ability to relieve pain. The secondary aims are to see if these 2 drugs have the same safety profile, nausea, vomiting and pruritis incidence and if patients in both groups are equally satisfied with their treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41242 0
Dr Petrus J Kotze
Address 41242 0
Mater Hospital
Raymond Terrace
South Brisbane
Qld
4101
Country 41242 0
Australia
Phone 41242 0
+61 7 31638111
Fax 41242 0
Email 41242 0
pierrekotze1@gmail.com
Contact person for public queries
Name 41243 0
Dr Petrus J Kotze
Address 41243 0
Mater Hospital
Raymond Terrace
South Brisbane
Qld
4101
Country 41243 0
Australia
Phone 41243 0
+61 7 3163 8111
Fax 41243 0
Email 41243 0
pierrekotze1@gmail.com
Contact person for scientific queries
Name 41244 0
Dr Petrus J Kotze
Address 41244 0
Mater Hospital
Raymond Terrace
South Brisbane
Qld
4101
Country 41244 0
Australia
Phone 41244 0
+61731638111
Fax 41244 0
Email 41244 0
pierrekotze1@gmail.com

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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