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Trial registered on ANZCTR


Registration number
ACTRN12613000076774
Ethics application status
Approved
Date submitted
18/01/2013
Date registered
21/01/2013
Date last updated
10/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Nurse Practitioner led Pain Management the day after Caesarean Section: A Randomised Controlled Trial
Scientific title
A Randomised Controlled Trial comparing a personalised pain intervention with immediate release oxycodone to controlled release oxycodone the day after Caesarean Section
Secondary ID [1] 281781 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
PAIN MANAGEMENT 288101 0
Condition category
Condition code
Reproductive Health and Childbirth 288476 288476 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For the analgesic component of the intervention, participants were prescribed scheduled IR oxycodone doses at 8:00 (10mg), 14:00 (5mg) and 20:00 hours (5mg), commencing the day after CS. Prior to the first dose, the NP allowed participants to discuss their caesarean experience, beliefs about pain and their expectations for pain management. The intervention included discussing concerns regarding analgesics as well as fears about pain when getting up to look after their baby. Any misconceptions were discussed and the proposed pain management plan was explained to each participant. This focused on how IR oxycodone could lessen pain interference on sitting up, mobilising and caring for a newborn. The NP explained that it would take one hour for a dose of IR oxycodone to reach peak analgesic effect, thereby reducing pain when increased pain was anticipated. The NP also explained that additional IR oxycodone or IR tramadol were available on request and that the IR doses only had an analgesic effect for a few hours. Maternal right to refuse any scheduled dose of oxycodone was reinforced in order to transfer decision-making power to participants. Reviews at 11:00 and 14:00 evaluated how participants perceived their progress in terms of pain intensity and function. If analgesia was inadequate, options for pain management were discussed, including commencing 10mg of CR oxycodone at 20:00 hours in place of the scheduled 5mg IR oxycodone dose. Both groups received equal doses of regular oxycodone on the first postoperative day but the groups differed in the formulation used. The control group received controlled-release (CR) oxycodone as the regular dose, whereas the intervention group received regular Immediate-release (IR) oxycodone. Both groups received equal opportunity for changes to their pain management plan.
Intervention code [1] 286349 0
Treatment: Drugs
Intervention code [2] 293246 0
Treatment: Other
Comparator / control treatment
The control group will receive the standard postoperative regimen consisting of 10 mg of controlled-release (CR) oxycodone commencing at 0800 on the first postoperative day and continuing every 12 hours for 2 days.
Control group
Active

Outcomes
Primary outcome [1] 288666 0
Pain Intensity: Visual Analogue Scale
Timepoint [1] 288666 0
Hourly from 0800-1200 on the first postoperative day, then at 0800 on the second postoperative morning
Primary outcome [2] 296596 0
Patient global impression of change in pain relief
Timepoint [2] 296596 0
Every hour for 4 hours following the first dose of oxycodone
Secondary outcome [1] 300731 0
Opioid-induced Side Effects (Drowsiness, Nausea, Itching) recorded on Visual Analogue Scales by participants.
Timepoint [1] 300731 0
From 0800 the day after surgery until 0800 on the second postoperative day
Secondary outcome [2] 300742 0
Pain Interference
Timepoint [2] 300742 0
Tool: Modified Brief Pain Inventory (Short Form) after 2000 on the first postoperative night and then 3 months after discharge from hospital
Secondary outcome [3] 300743 0
Postnatal Depression
Timepoint [3] 300743 0
Edinburgh Postnatal Depression Scale on the second postoperative day and then 3 months after discharge
Secondary outcome [4] 300744 0
Characteristics of Pain: McGill Pain Questionnaire (Short Form 2)
Timepoint [4] 300744 0
After 2000 on the first postoperative day and then 3 months after discharge from hospital
Secondary outcome [5] 300746 0
Perception of Control over Pain Management: Participants will record responses to five questions on Visual Analogue Scales
Timepoint [5] 300746 0
0800 on the second postoperative day
Secondary outcome [6] 307263 0
Graded Chronic Pain and Disability Scale
Timepoint [6] 307263 0
3 months after caesarean section
Secondary outcome [7] 318843 0
Opioid consumption
Timepoint [7] 318843 0
0-36 hours
Secondary outcome [8] 318844 0
Global assessment of pain management
Timepoint [8] 318844 0
20:00 hours following the protocol commencement

Eligibility
Key inclusion criteria
Public patients over 18 years of age English speaking (to reduce data collection error and costs) Scheduled for elective caesarean section the day prior to the intervention.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Chronic pain, opioid tolerance, history of substance abuse, allergies to agents used in the research or epilepsy or use of serotonin re-uptake inhibitors, obstructive sleep apnoea.

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)
Each sequentially numbered envelope contained the treatment group allocation and treatment protocol that will remain concealed until it is given by the researcher or assistant to the anaesthetist assigned to the morning operating list on the day of surgery. The sequential number will correspond to the research participant number on the master list from zero to one hundred and twenty.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence generation occurred via a computer-generated sequence based on a table of random numbers. It was generated by an independent researcher.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
The principal investigator will be involved with recruitment and data collection, but will remain blinded to the treatment allocation until the intervention is commenced.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
SPSS

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/05/2013
Actual
28/06/2013
Date of last participant enrolment
Anticipated
28/11/2014
Actual
28/11/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
122
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 439 0
Ipswich Hospital - Ipswich
Recruitment postcode(s) [1] 6203 0
4305 - Ipswich

Funding & Sponsors
Funding source category [1] 286589 0
University
Name [1] 286589 0
QUEENSLAND UNIVERSITY OF TECHNOLOGY
Country [1] 286589 0
Australia
Funding source category [2] 292375 0
Other Collaborative groups
Name [2] 292375 0
Australian College of Nursing
Country [2] 292375 0
Australia
Primary sponsor type
Individual
Name
IPSWICH HOSPITAL
Address
PO BOX 73 IPSWICH QLD 4305
Country
Australia
Secondary sponsor category [1] 285371 0
University
Name [1] 285371 0
QUEENSLAND UNIVERSITY OF TECHNOLOGY
Address [1] 285371 0
VICTORIA PARK ROAD, KELVIN GROVE QLD 4059
Country [1] 285371 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288663 0
WEST MORETON HEALTH HREC
Ethics committee address [1] 288663 0
Ethics committee country [1] 288663 0
Australia
Date submitted for ethics approval [1] 288663 0
04/03/2013
Approval date [1] 288663 0
15/05/2013
Ethics approval number [1] 288663 0
HREC/13/QWMS/8

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

Contacts
Principal investigator
Name 37074 0
Mr Anthony Schoenwald
Address 37074 0
PO Box 73
Ipswich QLD 4305
Country 37074 0
Australia
Phone 37074 0
+61734137930
Fax 37074 0
Email 37074 0
Anthony.Schoenwald@health.qld.gov.au
Contact person for public queries
Name 37075 0
ANTHONY SCHOENWALD
Address 37075 0
PO BOX 73
IPSWICH QLD 4305
Country 37075 0
Australia
Phone 37075 0
+61734137930
Fax 37075 0
Email 37075 0
Anthony.Schoenwald@health.qld.gov.au
Contact person for scientific queries
Name 37076 0
ANTHONY SCHOENWALD
Address 37076 0
PO BOX 73
IPSWICH QLD 4305
Country 37076 0
Australia
Phone 37076 0
+61734137930
Fax 37076 0
Email 37076 0
Anthony.Schoenwald@health.qld.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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