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Trial registered on ANZCTR


Registration number
ACTRN12618000287235p
Ethics application status
Not yet submitted
Date submitted
18/12/2017
Date registered
23/02/2018
Date last updated
23/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Controlled Trial of Cox-2 Selective versus Non-selective Non-Steroidal Anti-Inflammatory Drugs for Postoperative Analgesia in Caesarean Sections
Scientific title
Randomised Controlled Trial of Cox-2 Selective versus Non-selective Non-Steroidal Anti-Inflammatory Drugs for Postoperative Analgesia in Caesarean Sections
Secondary ID [1] 293632 0
None
Universal Trial Number (UTN)
U1111-1206-7287
Trial acronym
PARIBU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Caesarean Section 305906 0
Condition category
Condition code
Anaesthesiology 305095 305095 0 0
Pain management
Reproductive Health and Childbirth 305425 305425 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patient will randomised to one of two treatment groups. The intervention group and the active control group.

Intervention Post delivery of baby, 800 mg ibuprofen diluted in 250 ml normal saline given intravenously over 30 minutes. Oral ibuprofen will be started 12 hours after at 400mg twice daily per orally. This will be continued for 3 days.

Adherence will be monitored to ensure that the medication was given in theatre and medication will be charted in drug chart. If patient is not administered medication or it is refused it will be recorded.
The doses are predetermined doses and will be blinded to patient and staff.
Intervention code [1] 299893 0
Treatment: Drugs
Comparator / control treatment
The active control group

Post delivery of baby, the patient will receive parecoxib 40mg diluted in 250ml normal saline given intravenously over 30 minutes. After 12 hours the patient will receive 200mg of celecoxib twice daily per orally. This will be continued for 3 days.

Adherence will be monitored to ensure that the medication was given in theatre and medication will be charted in drug chart. If patient is not administered medication or it is refused it will be recorded.
The doses are predetermined doses and will be blinded to patient and staff.
Control group
Active

Outcomes
Primary outcome [1] 304271 0
24 hour area the curve pain scores.
Pain will be quantified using the 10 point numeric rating scale at 6, 12 and 24 hours and 24 hour area under the curve pain scores made.
Timepoint [1] 304271 0
The time points will be at 6, 12 and 24 hours post-operatively to make 24 hour area under the curve pain scores.
Secondary outcome [1] 341440 0
Amount of rescue analgesia -recorded amount of buprenorphine medication dispensed to patient, recorded amount of tramadol dispensed to patient. Other analgesia medications given to the patient will be recorded.

Timepoint [1] 341440 0
24 hours post operatively
Secondary outcome [2] 343208 0
Quality of Recovery. Validated 9 question QOR with each scored out of 0-2.. Quality of recovery score includes questions of generally well being, support, understanding of instructions, able to go to the toilet, ease of breathing, nausea, vomiting, and pain. This will be done 24 hours post operatively.
Timepoint [2] 343208 0
24 hours post operatively
Secondary outcome [3] 343209 0
Opioid Related Symptom Distress Questionaire. A validated 9 question score with each score out of 0-4. System distress questionnaire includes questions of fatigue, drowsiness, concentration, nausea, vomiting, dizziness, constipation, itchiness, difficulty with urination
Timepoint [3] 343209 0
24 hours post operatively

Eligibility
Key inclusion criteria
Patients having elective category 4 caesarean sections
Minimum age
18 Years
Maximum age
50 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Allergy or contraindications to non-steroidal anti-inflammatory drugs
abnormal placentation
peptic ulcer
coagulopathy
pre-eclampsia
renal dysfunction
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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Non-inferiority trial
200 participants
The number of patients recruited is based on showing a non-inferiority margin of 15% in 24 hour Area under the curve pain score swith 90% power.

Recruitment
Recruitment status
Not yet recruiting
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)
WA
Recruitment hospital [1] 10027 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 18362 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 298249 0
Hospital
Name [1] 298249 0
Department of Anaesthesia, King Edward Memorial Hospital for Women
Address [1] 298249 0
374 Bagot Road
Subiaco
WA 6008
Country [1] 298249 0
Australia
Primary sponsor type
Individual
Name
Dr Gareth Ansell
Address
Department of Anaesthesia, King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco
WA 6008
Country
Australia
Secondary sponsor category [1] 297364 0
Individual
Name [1] 297364 0
Dr Nolan Mcdonnell
Address [1] 297364 0
Department of Anaesthesia, King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco
WA 6008
Country [1] 297364 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 299255 0
Ethics committee address [1] 299255 0
Ethics committee country [1] 299255 0
Australia
Date submitted for ethics approval [1] 299255 0
28/02/2018
Approval date [1] 299255 0
Ethics approval number [1] 299255 0

Summary
Brief summary
Caesarean Section is a procedure commonly performed in Australia and worldwide. In Western Australia 34% of deliveries are performed by caesarean section. The procedure is performed under neuraxial anaesthesia for 98% of procedures in Western Australia. Pain following caesarean section is common with majority of patients requiring opiate analgesia. Despite being a procedure that is performed commonly there is a wide variety of both intraoperative and postoperative analgesia regimes. There has been conflicting evidence of the value of giving non-steroidal anti-inflammatory drugs (NSAIDs) on reducing post-operative analgesia requirements and whether non-selective NSAIDs are more effective than selective NSAIDs. The study will randomise the patient to receive either a non-selective or selective NSAID and assess whether there is any difference in pain scores. The null hypothesis is that there will be no difference in pain scores in the treatment groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79806 0
Dr Gareth Ansell
Address 79806 0
Department of Anaesthesia, King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco
WA 6008
Country 79806 0
Australia
Phone 79806 0
+618 6458 2222
Fax 79806 0
Email 79806 0
gareth.ansell@health.wa.gov.au
Contact person for public queries
Name 79807 0
Dr Gareth Ansell
Address 79807 0
Department of Anaesthesia, King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco
WA 6008
Country 79807 0
Australia
Phone 79807 0
+618 6458 2222
Fax 79807 0
Email 79807 0
gareth.ansell@health.wa.gov.au
Contact person for scientific queries
Name 79808 0
Dr Gareth Ansell
Address 79808 0
Department of Anaesthesia, King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco
WA 6008
Country 79808 0
Australia
Phone 79808 0
+618 6458 2222
Fax 79808 0
Email 79808 0
gareth.ansell@health.wa.gov.au

No data has been provided for results reporting
Summary results
Not applicable