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Trial registered on ANZCTR


Registration number
ACTRN12609001041246
Ethics application status
Approved
Date submitted
19/11/2009
Date registered
4/12/2009
Date last updated
12/03/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Parecoxib, celecoxib and paracetamol for pain management following caesarean delivery
Scientific title
In women receiving spinal anaesthesia for caesarean section, is there a difference in the opioid dose-sparing, analgesic efficacy and quality of post-operative pain relief provided by multimodal postoperative analgesic regimens based on patient controlled epidural analgesia (PCEA) with pethidine, together with either placebo, cyclo-oxygenase 2 enzyme (COX-2) inhibitors, paracetamol or COX-2 inhibitors and paracetamol in combination.
Secondary ID [1] 1160 0
Nil
Universal Trial Number (UTN)
Trial acronym
The COMMAND Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain relief after caesarean delivery 252160 0
Condition category
Condition code
Reproductive Health and Childbirth 252361 252361 0 0
Childbirth and postnatal care
Anaesthesiology 252362 252362 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All women will receive patient-controlled epidural analgesia (PCEA) with pethidine (20 mg bolus, 15 minute lock-out, no background) and either:
1) placebo (intravenous normal saline 2 ml & normal saline 200 ml intra-operatively; oral placebo capsules - 2 capsules at 6 and 18 hours postoperatively & 4 capsules at 12 hours postoperatively)
2) cyclo-oxygenase 2 enzyme (COX-2) inhibitors (intravenous parecoxib 40 mg in 2 ml normal saline and placebo [normal saline 200 ml] intra-operatively; post-operatively, oral celecoxib 400 mg [2 x 200 mg capsules] at 12 hours postoperatively and 2 placebo capsules PO at 6, 12 and 18 hours)
3) intravenous paracetamol 2 g in 200 ml normal saline and intravenous normal saline 2 ml intra-operatively; post-operatively, oral paracetamol 1 g [2 x 500 mg capsules] at 6, 12 and 18 hours and 2 additional placebo capsules at 12 hours
4) COX-2 inhibitors and paracetamol in combination (intravenous parecoxib 40 mg in 2 ml normal saline and paracetamol 2 g in 200 ml normal saline intra-operatively; post-operatively, oral paracetamol 1 g [2 x 500 mg capsules] at 6, 12 and 18 hours and oral celecoxib 400 mg [2 x 200 mg capsules] at 12 hours)
Intra-operative drugs will be given after delivery. All women will have access to rescue analgesia - immediate release oral tramadol 100 mg 2 hourly (maximum 600 mg in 24 hours).
The placebo capsules are cornstarch in a gelatin capsule.
The paracetamol 2 g in 200 ml normal saline or the placebo equivalent of 200 ml normal saline will be infused over 15 minutes.
The parecoxib 40 mg in 2 ml normal saline or the placebo equivalent of 2 ml normal saline will be given as a bolus.
Intervention code [1] 241531 0
Treatment: Drugs
Comparator / control treatment
The control group will receive patient-controlled epidural analgesia plus placebos.
Control group
Placebo

Outcomes
Primary outcome [1] 253291 0
Epidural pethidine consumption in the first 24 hours postoperatively
Timepoint [1] 253291 0
0 to 24 hours post-operatively
Secondary outcome [1] 262320 0
Efficacy of the analgesic regimen determined by the area under the curve for rest and dynamic (movement-induced) pain scores in the first 24 hours postoperatievly
Timepoint [1] 262320 0
24 hours post-operatively: at 6, 12 & 24 hours
Secondary outcome [2] 262321 0
Efficacy of the analgesic regimen determined by the pain scores at rest and with movement
Timepoint [2] 262321 0
6,12 and 24 hours post-operatively
Secondary outcome [3] 262322 0
Incidence of analgesic supplementation with oral tramadol
Timepoint [3] 262322 0
to 24 hours post-operatively (the starting or '0' timepoint is the end of surgery)
Secondary outcome [4] 262323 0
Maternal satisfaction with analgesic regimen. This will be assessed using a 0-10 numerical rating score, a satisfaction rating of excellent/good/fair/poor and free comments
Timepoint [4] 262323 0
48 hours post-operatively

Eligibility
Key inclusion criteria
Elective caesarean section under combined spinal epidural anaesthesia
American Society of Anesthesiologists classification 1 or 2
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-operative use of opioid medication
Contraindication to combined spinal epidural anaesthesia
Contraindication to parecoxib, celecoxib, paracetamol or tramadol
Known intolerance or allergy to oxycodone, morphine, parecoxib, celecoxib or sulphonamides
Pre-operative pruritus or nausea
Failure to identify the subarachnoid space or to catheterise the epidural space at the time of combined spinal epidural anaesthesia
Inadvertent dural puncture with the epidural needle or catheter
Requirement for intra-operative opioid or epidural analgesics other than local anaesthetic
Conversion to general anaesthesia

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)
Women will be recruited at antenatal pre-admission caesarean section clinics, from the maternal-fetal assessment unit, labour and birthing unit or the hospital antenatal ward. All women must have consented to combined spinal epidural anaesthesia and informed consent for the study will be obtained. Randomisation and allocation will be performed by the hospital pharmacy department, with women being allocated to 1 of 4 groups. All study drugs will be prepared in blinded fashion and using identical placebos to active drug, by the hospital pharmacy.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Randomised, placebo-controlled, double-dummy
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
An intention to treat analysis Continuous data were summarised using median, interquartile range (IQR) and range (R) and categorical data using frequency distributions. Univariate comparisons of continuous outcomes between treatment groups were conducted using Kruskal-Wallis tests. Pair-wise comparisons between control and treatment groups were made with an overall family-wise type 1 error controlled at alpha 0.05. The Chi-square test was used for comparisons of categorical outcomes. Area under the curve (AUC) for rest and movement pain to 24 hours was calculated using the trapezium rule; missing data at some time points were imputed by carrying the last observation forward. P-values < 0.05 were considered statistically significant. The analysis was performed by an author (EAN) using SPSS 18.0 for Windows (SPSS, Chicago, IL) and StatXact 8.0, Cytel Inc, 2007.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2010
Actual
18/02/2010
Date of last participant enrolment
Anticipated
Actual
14/02/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 244055 0
Commercial sector/Industry
Name [1] 244055 0
Pfizer Ltd
Country [1] 244055 0
Australia
Primary sponsor type
Hospital
Name
King Edward Memorial Hospital for Women
Address
King Edward Memorial Hospital for Women, 374 Bagot Road, Subiaco, WA 6008.
Country
Australia
Secondary sponsor category [1] 251402 0
None
Name [1] 251402 0
Address [1] 251402 0
Country [1] 251402 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258138 0
King Edward Memorial Hospital for Women Ethics Committee, Women and Newborn Health Service
Ethics committee address [1] 258138 0
Ethics committee country [1] 258138 0
Australia
Date submitted for ethics approval [1] 258138 0
Approval date [1] 258138 0
06/10/2009
Ethics approval number [1] 258138 0
1736/EW

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

Contacts
Principal investigator
Name 30489 0
Prof Michael Paech
Address 30489 0
Department of Anaesthesia and Pain Medicine, King Edward Memorial Hospital for Women, 374 Bagot Road, Subiaco, WA 6008
Country 30489 0
Australia
Phone 30489 0
+61893402222
Fax 30489 0
Email 30489 0
micahel.paech@health.wa.gov.au
Contact person for public queries
Name 13736 0
Michael Paech
Address 13736 0
Department of Anaesthesia and Pain Medicine, King Edward Memorial Hospital for Women, 374 Bagot Road, Subiaco, WA 6008.
Country 13736 0
Australia
Phone 13736 0
+ 61 8 93402222
Fax 13736 0
+ 61 8 93402260
Email 13736 0
michael.paech@health.wa.gov.au
Contact person for scientific queries
Name 4664 0
Michael Paech
Address 4664 0
Department of Anaesthesia and Pain Medicine, King Edward Memorial Hospital for Women, 374 Bagot Road, Subiaco, WA 6008.
Country 4664 0
Australia
Phone 4664 0
+ 61 8 93402222
Fax 4664 0
+ 61 8 93402260
Email 4664 0
michael.paech@health.wa.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

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