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Trial registered on ANZCTR


Registration number
ACTRN12614001144606
Ethics application status
Approved
Date submitted
14/10/2014
Date registered
29/10/2014
Date last updated
22/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of the overall pain scores post caesarean section, when initial intraoperative analgesia is given intravenously (IV) versus per rectum (PR).
Scientific title
Randomised controlled trial comparing initial perioperative analgesia in women having a caesarean section to determine if intravenous analgesia is superior to per rectum analgesia, as determined by visual analogue scale pain scores and total opioid consumption.
Secondary ID [1] 285490 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PRIVA Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Analgesic requirements post caesarean section 293281 0
Condition category
Condition code
Anaesthesiology 293545 293545 0 0
Pain management
Reproductive Health and Childbirth 293633 293633 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Perioperative analgesia:
Intravenous arm of the trial:
1 g paracetamol
40 mg parecoxib
20 mg oxycontin orally in the post anaesthesia care unit

IV paracetamol and IV parecoxib are given by the attending anaesthetist after delivery of the neonate, prior to the parturient leaving the operating theatre to be managed in the Postoperative Care Unit (PACU). IV paracetamol is given over 10 minutes, whereas IV parecoxib is often given as a push.

As per this study protocol, there are no specific analgesic requirements, however, it is usual practice for the anaesthetist to chart on the patient's medical chart, either Targin or Oxycontin 10-20 mg twice daily and paracetamol 1g four times daily as a regular dose. A non-steroidal anti-inflammatory drug (NSAID), either ibuprofen 400 mg three times daily or diclofenac 100 mg three times daily is charted either as a regular dose, or as required, oxycodone 5 - 10 mg as required is charted and occasionally tramadol 50 - 100 mg four times daily as required is charted as well. All of these medications are given once the patient has left PACU and is being managed on the ward.
Intervention code [1] 290430 0
Treatment: Drugs
Comparator / control treatment
Control (standard treatment). Initial perioperative analgesia via the rectal route:
1 g paracetamol PR
100 mg diclofenac PR
30 mg oxycodone (Proladone) PR

All of the above medications are given PR by the obstetrician at the completion of the caesarean section, immediately prior to transfer to PACU.

As per this study protocol, there are no specific analgesic requirements, however, it is usual practice for the anaesthetist to chart on the patient's medical chart, either Targin or Oxycontin 10-20 mg twice daily and paracetamol 1g four times daily as a regular dose. A non-steroidal anti-inflammatory drug (NSAID), either ibuprofen 400 mg three times daily or diclofenac 100 mg three times daily is charted either as a regular dose, or as required, oxycodone 5 - 10 mg as required is charted and occasionally tramadol 50 - 100 mg four times daily as required is charted as well. All of these medications are given once the patient has left PACU and is being managed on the ward.
Control group
Active

Outcomes
Primary outcome [1] 293365 0
From the patient's medication chart the total opioid consumption for the first 48 hours post caesarean section is compiled. If the patient received morphine or fentanyl, in addition to the medications listed previously, these are converted into oxycodone equivalents. Likewise, if the patient received tramadol, this is converted into oxycodone equivalents, such that the total opioid consumption for the first 48 hours may be summated.
Timepoint [1] 293365 0
Patients are usually discharged on day 3 post caesarean section, with the day of surgery being day 0. All of their opioid requirements from the time of surgery up to and including midnight of day 2, post procedure are determined. On occasion, patients are discharged earlier (day 2 post caesarean section) and in this case, all of their opioid requirements up to and including the time of discharge are determined. Note however, that if the patient is discharged home with ongoing opioids for analgesia, these opioids are not included in the total count.
Secondary outcome [1] 310859 0
Visual analogue pain score at time of discharge from hospital
Timepoint [1] 310859 0
The visual analogue pain score is assessed by the primary investigator before 08.00 on day 3 post procedure, immediately prior to discharge from the hospital. On those occasions when patients were discharged home one day early, the domicillary midwives assessed the visual analogue pain score in the patient's house in the morning of the day that they would have normally been assessed by the primary investigator.
Secondary outcome [2] 310860 0
Current pain intensity at time of discharge by the placement of a tick beside the word in a vertical list of words that describes present pain intensity (PPI) from no pain to excruciating where:
0 = No pain
1 = Mild
2 = Discomforting
3 = Distressing
4 = Horrible
5 = Excruciating
Timepoint [2] 310860 0
The present pain intensity (PPI) score is assessed by the primary investigator before 08.00 on day 3 post procedure, immediately prior to discharge from the hospital. On those occasions when patients were discharged home one day early, the domicillary midwives assessed the PPI score in the patient's house in the morning of the day that they would have normally been assessed by the primary investigator.
Secondary outcome [3] 310861 0
Patients determination of their worst pain experienced since caesarean section, as determined by a visual analogue scale.
Timepoint [3] 310861 0
Determination of the patient's worst pain is assessed using the visual analogue pain score by the primary investigator before 08.00 on day 3 post procedure, immediately prior to discharge from the hospital. On those occasions when patients were discharged home one day early, the domicillary midwives assessed the patient's worst pain score using the visual analogue pain score in the patient's house in the morning of the day that they would have normally been assessed by the primary investigator.
Secondary outcome [4] 310862 0
Pain on discharge as assessed by the Short form McGill Pain Questionnaire.
Timepoint [4] 310862 0
The pain on discharge is assessed using the Short form McGill Pain Questionnaire by the primary investigator before 08.00 on day 3 post procedure, immediately prior to discharge from the hospital. On those occasions when patients were discharged home one day early, the domicillary midwives assessed the patient's pain using the Short form McGill Pain Questionnaire in the patient's house in the morning of the day that they would have normally been assessed by the primary investigator.

Eligibility
Key inclusion criteria
Caesarean section either elective or emergency
Minimum age
18 Years
Maximum age
50 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient refusal

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)
Allocation concealment using sequential opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Prior to undertaking this randomised controlled trial, an audit was undertaken at our Insititution for the month of March 2014, in which the total 48 hour opioid use for parturients who received intraoperative IV analgesia was determined. An average of 137.3 mg with a standard deviation of 27.7 mg was determined. Using these values and a pre-determined clinical significance of 20% reduction in opioid requirements for the intravenous group compared to the per rectum group, the estimated sample size was determined assuming a 95% confidence interval and 80% power. The calculated sample size was 17 per group ie 34 patients in total. Assuming that patients may be lost to follow up and or non-compliance of either treatment, it was decided to enroll 50 patients into either group, thus a total sample size of 100 patients.

Recruitment
Recruitment status
Completed
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 in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3048 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 8819 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 290093 0
Self funded/Unfunded
Name [1] 290093 0
Address [1] 290093 0
Country [1] 290093 0
Primary sponsor type
Individual
Name
Darren Lowen
Address
Department of Anaesthesia and Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country
Australia
Secondary sponsor category [1] 288794 0
None
Name [1] 288794 0
Address [1] 288794 0
Country [1] 288794 0
Other collaborator category [1] 278199 0
Individual
Name [1] 278199 0
Jun Keat Chan
Address [1] 278199 0
Department of Anaesthesia and Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country [1] 278199 0
Australia
Other collaborator category [2] 278200 0
Individual
Name [2] 278200 0
David Pescod
Address [2] 278200 0
Department of Anaesthesia and Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country [2] 278200 0
Australia
Other collaborator category [3] 278201 0
Individual
Name [3] 278201 0
Paul Howat
Address [3] 278201 0
Department of Obstetrics and Gynaecology
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country [3] 278201 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291801 0
Northern Health HREC
Ethics committee address [1] 291801 0
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Ethics committee country [1] 291801 0
Australia
Date submitted for ethics approval [1] 291801 0
10/06/2014
Approval date [1] 291801 0
13/08/2014
Ethics approval number [1] 291801 0
PO10/14

Summary
Brief summary
Currently, opinion amongst obstetric anaesthetists is divided as to whether an intravenous (IV) route is superior to the per rectum (PR) route for perioperative mangagement of post caesarean section pain. An audit of the mean total 48 hour opioid requirements post caesaren section was undertaken at The Northern Hospital during March 2014. This did not reveal a difference in the mean opioid requirement between the two different routes of analgesia administration. Despite this, there is a significant increased cost associated with the use of IV analgesia. It has been estimated that for every 4,000 deliveries, by not using IV analgesia, a cost saving of $20,000.00 will result.

Therefore, we wish to conduct a randomised controlled trial, using current Australian TGA approved medications and formulations, in line with current obstetric anaesthesia practice to determine if the IV route provides superior analgesia. As such, we would expect to find a 20% decrease in total 48 hour opioid consumption when the IV route is compared to the PR route. Statistical anlaysis of the prior audit has determined that we will need to recruit 50 women into each arm of this trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52074 0
Dr Darren Lowen
Address 52074 0
Department of Anaesthesia and Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country 52074 0
Australia
Phone 52074 0
+610402832336
Fax 52074 0
Email 52074 0
dlowen@gmp.usyd.edu.au
Contact person for public queries
Name 52075 0
Dr Darren Lowen
Address 52075 0
Department of Aanesthesia and Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country 52075 0
Australia
Phone 52075 0
+610402832336
Fax 52075 0
Email 52075 0
dlowen@gmp.usyd.edu.au
Contact person for scientific queries
Name 52076 0
Dr Darren Lowen
Address 52076 0
Department of Anaesthesia and Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country 52076 0
Australia
Phone 52076 0
+610402832336
Fax 52076 0
Email 52076 0
dlowen@gmp.usyd.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary