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Trial registered on ANZCTR


Registration number
ACTRN12615000997550
Ethics application status
Approved
Date submitted
10/09/2015
Date registered
23/09/2015
Date last updated
8/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of the overall pain scores post elective 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] 287427 0
Nil
Universal Trial Number (UTN)
U1111-1174-0798
Trial acronym
TRAMOD Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Analgesic requirements post elective caesarean section 296141 0
Condition category
Condition code
Anaesthesiology 296408 296408 0 0
Pain management
Reproductive Health and Childbirth 296521 296521 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

Intravenous paracetamol and intravenous 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). Intravenous paracetamol is given over 10 minutes, whereas intravenous parecoxib is often given as a push. Any variation to this protocol will be recorded as a protocol deviation.

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] 292786 0
Treatment: Drugs
Comparator / control treatment
Control (standard treatment). Initial perioperative analgesia via the rectal route:
1 g paracetamol
100 mg diclofenac
30 mg oxycodone (Proladone)

All of the above medications are given per rectum by the obstetrician at the completion of the caesarean section, immediately prior to transfer to PACU. Any variation to this protocol will be recorded as a protocol deviation.

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] 296047 0
Pain assessment at discharge, as determined by participant responses to a multidimensional pain score, which has previously been validated for use in labouring women – SF-MPQ, when the intravenous route of initial perioperative, post-caesarean section analgesia is compared to the per rectum route of perioperative, post-caesarean analgesia.
Timepoint [1] 296047 0
At 0800 on day 3 post procedure, immediately prior to discharge from the hospital, or on the same day at home by midwives, if the patient was discharged home earlier.
Secondary outcome [1] 317351 0
Visual analogue pain score at time of discharge from hospital
Timepoint [1] 317351 0
At 0800 on day 3 post procedure, immediately prior to discharge from the hospital, or on the same day at home by midwives, if the patient was discharged home earlier.
Secondary outcome [2] 317352 0
Present pain intensity at time of discharge from the hospital. The present pain intensity is part of the form for the SF-MPQ, which has previously been validated for use in labouring women and is scored by the placement of a tick beside the word in a vertical ist 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] 317352 0
At 0800 on day 3 post procedure, immediately prior to discharge from the hospital, or on the same day at home by midwives, if the patient was discharged home earlier.
Secondary outcome [3] 317353 0
Patient's determination of their worst pain experienced since caesarean section, as determined by a visual analogue scale.
Timepoint [3] 317353 0
At 0800 on day 3 post procedure, immediately prior to discharge from the hospital, or on the same day at home by midwives, if the patient was discharged home earlier.
Secondary outcome [4] 317609 0
Quality of recovery post surgery as determined by the QoR-15 questionnaire.
Timepoint [4] 317609 0
At 0800 on day 3 post procedure, immediately prior to discharge from the hospital, or on the same day at home by midwives, if the patient was discharged home earlier.
Secondary outcome [5] 317610 0
Total opioid consumption via the two different routes. 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 [5] 317610 0
From the time of elective caesarean section, up to and including midnight of day 2, post procedure, with the day of surgery being day 0.
Secondary outcome [6] 317611 0
The total cost of all analgesia required by patients allocated to the two different groups will be summated. This will include the cost of opioids, as well as the cost of any associated ancilliary analgesia (paracetamol and NSAIDS).
Timepoint [6] 317611 0
From the time of elective caesarean section, up to and including midnight of day 2, post procedure, with the day of surgery being day 0.

Eligibility
Key inclusion criteria
Elective caesarean section
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient refusal
Non English speaking background

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)
Initial verbal agreement via telephone at least 48 hours prior to elective caesarean section. Written confirmation of agreement on the day of elective caesarean section surgery. 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
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Recently, a prospective audit was conducted at the Northern Hospital. This audit assigned 50 women to receive intravenous analgesia and a further 50 women received per rectum analgesia post caesarean section, which was either an elective or an emergency procedure. Analysis of the data revealed that the group who had received intravenous analgesia had a lower 48 hour oxycodone usage of 148.9 +/- 36.7 compared to the per rectum analgesia group, which had a 48 hour oxycodone usage of 170.0 +/- 47.5 mg. This difference is a 12.4% reduction. Despite this apparent difference in opioid requirements, there did not appear to be a difference in pain scores as reflected by the fact that for three of the four pain questionnaires, all of which were unidimensional measurements of pain, there was no statistical difference between the two groups. For the fourth pain questionnaire, which measures the multidimensional aspect of pain, a statistical difference was found favouring the group who had received intravenous analgesia.

Therefore, we wish to expand upon these findings and would like to propose a non-blinded randomised controlled trial comparing the intravenous route to the per rectum route. Based on data previously obtained, if the intravenous route provided better analgesia, we propose that there should be a 20% reduction in the total pain score as determined by the multidimensional pain questionnaire (SF-MPQ).

Using data from previous audits, Mr Mark Tacey, a biostatistician, has determined that we will need to recruit 89 participants into each arm of the trial, using a power of 80% and a two-sided alpha of 0.05%. To allow for incomplete and missing data, we have increased the sample size to 100 participants for each arm of the trial, thus making a total of 200 participants to be recruited.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/10/2015
Actual
29/09/2015
Date of last participant enrolment
Anticipated
5/10/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4311 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 10468 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 292003 0
Self funded/Unfunded
Name [1] 292003 0
Country [1] 292003 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] 290668 0
Individual
Name [1] 290668 0
Jun Keat Chan
Address [1] 290668 0
Department of Anaesthesia and Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country [1] 290668 0
Australia
Secondary sponsor category [2] 290669 0
Individual
Name [2] 290669 0
David Pescod
Address [2] 290669 0
Department of Anaesthesia and Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country [2] 290669 0
Australia
Secondary sponsor category [3] 290670 0
Individual
Name [3] 290670 0
Paul Howat
Address [3] 290670 0
Department of Obstetrics and Gynaecology
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country [3] 290670 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293491 0
Northern Health HREC
Ethics committee address [1] 293491 0
Ethics committee country [1] 293491 0
Australia
Date submitted for ethics approval [1] 293491 0
Approval date [1] 293491 0
24/08/2015
Ethics approval number [1] 293491 0
HREC/15/NH/15

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

Contacts
Principal investigator
Name 60122 0
Dr Darren Lowen
Address 60122 0
Department of Anaesthesia and Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country 60122 0
Australia
Phone 60122 0
+61402832336
Fax 60122 0
Email 60122 0
dlowen@gmp.usyd.edu.au
Contact person for public queries
Name 60123 0
Darren Lowen
Address 60123 0
Department of Anaesthesia and Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country 60123 0
Australia
Phone 60123 0
+61402832336
Fax 60123 0
Email 60123 0
dlowen@gmp.usyd.edu.au
Contact person for scientific queries
Name 60124 0
Darren Lowen
Address 60124 0
Department of Anaesthesia and Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country 60124 0
Australia
Phone 60124 0
+61402832336
Fax 60124 0
Email 60124 0
dlowen@gmp.usyd.edu.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

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