Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001345178
Ethics application status
Approved
Date submitted
3/09/2019
Date registered
1/10/2019
Date last updated
11/02/2020
Date data sharing statement initially provided
1/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Patient controlled oral analgesia (PCOA) following Caesarean delivery.
Scientific title
Patient controlled oral analgesia (PCOA) for women following caesarean section delivery: A Non inferiority study.
Secondary ID [1] 299162 0
None
Universal Trial Number (UTN)
U1111-1189-7396
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute post operative pain 314236 0
Caesarean Delivery 314397 0
Condition category
Condition code
Anaesthesiology 312600 312600 0 0
Pain management
Reproductive Health and Childbirth 312601 312601 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Baseline audit performed looking at quality of recovery after caesarean delivery was completed in 2016 over a 2 month period. Intervention will be the introduction of a standardised analgesic regime using patient controlled oral analgesia (PCOA). A repeat audit will then be preformed to ensure non-inferiority.

Patient controlled oral analgesia (PCOA) following caesarean section.

Women at Hutt hospital who have had a caesearean section and are in a postiion pre-operatively to consent to be in the study may be recruited.
If the woman opts into the study they will be given a 7 day medication pack post caesarean section in the post anaesthetic recovery room which they will keep with them during their stay and can take home with them. During their stay the medication pack will be kept in a lockable bag that is bolted to the wall beside their bed.

The medication pack contains the same medications normally charted at Hutt hospital for pain relief following caesarean section. They will take the medication themselves from the pack at 4-6 hourly intervals.
The medication pack contains:
Paracetamol 2 x 500mg oral tablets to take four times a day
Ibuprofen 2x 200mg oral tablets to take four times a day
Tramadol 1x 50mg oral capsule to take four times a day.

They are shown how to identify tramadol in the packs and if when the medication is due to be taken they do not think they need the tramadol they are instructed to take it out of the pack and leave it in the lockable bag.

All women who have these packs are also charted additional medications for women following caesarean section on our national drug chart which can be brought to them by the midwife as needed including further analgesia, anti-emetics and anti-puretic.

The medication pack will be checked once daily on the pm shift by the maternity staff. Missed doses recorded and discarded.

The women can take their medication packs home with them and they will also be given a discharge script for more oral analgesia from the obstetric team looking after the patient. What is prescribed is determined by obstetric team and is not standardised. It usually contains paracetamol, ibuprofen or diclofenac and tramadol.

The women are followed in hospital with two visits on the post natal ward and one phone call day 10 post caesarean section.

If the woman does not want to participate or are not in a position to consent preoperatively they will recieve their analgesic medication from the maternity staff.
Intervention code [1] 315448 0
Treatment: Other
Intervention code [2] 315548 0
Treatment: Drugs
Comparator / control treatment
We have completed a baseline audit from August 2016- September 2016 of our current practice which we will use as the comparison group for patient controlled oral analgesia.

Our current practice is the anaesthetist prescribes analgesia for the woman following her caesarean section.
The analgesia prescribed is usually oral paracetamol 1g four times a day regularly, a non steroidal antiinflammatory either oral ibuprofen 400mg four times a day regularly or oral diclofenac 75 mg twice a day regularly. Tramadol oral or intravenous 100mg four times a day as required for pain relief and Morphine orally 10-20mg up to 2 hourly as required for pain relief. These are for while the woman is in hospital,

When being discharged from hospital the woman is provided with a discharge script for more oral analgesia from the obstetric team looking after the patient. What is prescribed is determined by obstetric team and is not standardised. It usually contains paracetamol, ibuprofen or diclofenac and tramadol.
Control group
Historical

Outcomes
Primary outcome [1] 321247 0
The quality of recovery assessed using the Quality of recovery -15 score in patients recieving patient controlled oral analgesia packs compared with patients recieving medication dispensed by post natal staff.
Timepoint [1] 321247 0
Assessed day 1, day 2, and day 4 (primary endpoint), Followed up on day 10 for qualitative input from the women.
Secondary outcome [1] 374447 0
Number of patients recieving paracetamol as charted.
Timepoint [1] 374447 0
Reviewed after hospital discharge.
Secondary outcome [2] 374780 0
Number of patients receiving non-steroidal antiinflammatory medication as charted.
Timepoint [2] 374780 0
Reviewed after hospital discharge.

Eligibility
Key inclusion criteria
Women having a caesarean section at Hutt Hospital.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Catagory 1 emergency caesarean section
Any emergency caesarean section in which the woman in not in a position to give consent including due to time pressure, pain, feeling overwhelmed
Allergy or significant adverse reaction to paracetamol, ibuprofen or tramadol
Pre-eclampsia and HELLP syndrome
Seizure disorder requiring anti-epileptics
Documented history of drug misuse of mother or partner
Inability to understand PCOA process for example due to Intellectual/cognitive impairment, Language barriers
Risk of serotonin syndrome
The woman does not wish to participate

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
A audit of our current practice has been completed and will be used as a comparison group for patients with patient controlled oral analgesia.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The audit requires 35 women to be included in order for the study to determine non-inferiority to 90% statistical certainty.
We will consider a clinically significant change in QoR-15 score to be 8
We have selected a higher sample size due to potential drop out after signing the consent form - such as an unexpected intraoperative course may mean the patient is not capable of managing PCOA post op.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
22/07/2019
Date of last participant enrolment
Anticipated
30/01/2020
Actual
3/12/2019
Date of last data collection
Anticipated
10/02/2020
Actual
13/12/2019
Sample size
Target
45
Accrual to date
Final
38
Recruitment outside Australia
Country [1] 21827 0
New Zealand
State/province [1] 21827 0
Lower Hutt

Funding & Sponsors
Funding source category [1] 303703 0
Hospital
Name [1] 303703 0
Hutt Hosptial
Country [1] 303703 0
New Zealand
Primary sponsor type
Individual
Name
Johanna Pigou
Address
Hutt Hospital
638 High St
Lower Hutt 5010
Country
New Zealand
Secondary sponsor category [1] 303811 0
Individual
Name [1] 303811 0
Han Truong
Address [1] 303811 0
Hutt Hosptial
638 High St
Lower Hutt 5010
Country [1] 303811 0
New Zealand
Secondary sponsor category [2] 303812 0
Individual
Name [2] 303812 0
Alisa Ireland
Address [2] 303812 0
Wellington Hospital
Riddiford St
Newtown 6021
Country [2] 303812 0
New Zealand
Other collaborator category [1] 280930 0
Individual
Name [1] 280930 0
Sue O'Connor
Address [1] 280930 0
Hutt Hospital
638 High St
Lower Hutt 5010
Country [1] 280930 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304228 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 304228 0
Ethics committee country [1] 304228 0
New Zealand
Date submitted for ethics approval [1] 304228 0
Approval date [1] 304228 0
13/06/2019
Ethics approval number [1] 304228 0
19/CEN/56

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96206 0
Dr Johanna Pigou
Address 96206 0
Hutt Hospital
638 High St
Lower Hutt 5010
Country 96206 0
New Zealand
Phone 96206 0
+64 0273577663
Fax 96206 0
Email 96206 0
[email protected]
Contact person for public queries
Name 96207 0
Johanna Pigou
Address 96207 0
Hutt Hospital
638 High St
Lower Hutt 5010
Country 96207 0
New Zealand
Phone 96207 0
+64 0273577663
Fax 96207 0
Email 96207 0
[email protected]
Contact person for scientific queries
Name 96208 0
Johanna Pigou
Address 96208 0
Hutt Hospital
638 High St
Lower Hutt 5010
Country 96208 0
New Zealand
Phone 96208 0
+64 0273577663
Fax 96208 0
Email 96208 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual patient data will not be made pubically available as per our ethics consent form.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4498Ethical approval    378287-(Uploaded-03-09-2019-09-32-17)-Study-related document.pdf



Results publications and other study-related documents

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