Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000506594
Ethics application status
Approved
Date submitted
6/12/2006
Date registered
7/12/2006
Date last updated
19/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Oral analgesia compared with intrathecal morphine for pain after caesarean delivery: a randomised controlled trial
Scientific title
Oral oxycodone analgesia compared with intrathecal morphine for pain relief after caesarean delivery: a randomised controlled trial
Secondary ID [1] 281266 0
1297/EW
Universal Trial Number (UTN)
Trial acronym
The SMOOTH study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain relief after caesarean section 1484 0
Condition category
Condition code
Reproductive Health and Childbirth 1578 1578 0 0
Other surgery
Reproductive Health and Childbirth 1579 1579 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group: Intrathecal morphine 100 mcg given with spinal anaesthesia immediately preoperatively. Both control group and intervention groups also receiving oral paracetamol 1 g in recovery and 6 hourly until 24 hours postoperatively plus diclofenac 100 mg per rectum at completion of surgery and diclofenac 50 mg orally 8 hourly until 24 hours postoperatively, after caesarean section.
Intervention code [1] 1488 0
Treatment: Drugs
Comparator / control treatment
Oral sustained release oxycodone 20 mg as soon as the patient has been transferred to the recovery room followed by oral immediate-release oxycodone 10 mg 6 hourly until 24 hours postoperatively
Control group
Active

Outcomes
Primary outcome [1] 2182 0
Area under the curve at 24 hours for pain scores
Timepoint [1] 2182 0
At 6,12, 18 and 24 hours postoperatively
Secondary outcome [1] 3805 0
Pain on movement
Timepoint [1] 3805 0
at 12 and 24 hours postoperatively
Secondary outcome [2] 3806 0
Quality of recovery
Timepoint [2] 3806 0
at 24 hours postoperatively
Secondary outcome [3] 3807 0
Opioid-related symptom distress scale score
Timepoint [3] 3807 0
at 24 hours postoperatively
Secondary outcome [4] 3808 0
Patient satisfaction score
Timepoint [4] 3808 0
at 24 hours postoperatively

Eligibility
Key inclusion criteria
Elective or non-elective caesarean section under combined spinal-epidural or spinal anaesthesia American Society of Anesthesiologists classification 1 or 2
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Preoperative opioid useContraindication, allergy or known intolerance to study drugsPreoperative nausea or pruritusFailure to identify the subarachnoid space or accidental dural puncture with the epidural needleRequirement for intraoperative opioid or epidural analgesic other than local anaesthetic Conversion to general anaesthesia.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation in hospital pharmacy
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated randomisation sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Placebo controlled; double-dummy design with patients, therapists (anaesthetists), assessors (nurses and research assistants) blind to group allocation
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 358 0
6008

Funding & Sponsors
Funding source category [1] 1723 0
Other Collaborative groups
Name [1] 1723 0
Australian and New Zealand College of Anaesthetists Lennard Travers Professorship Grant
Country [1] 1723 0
Australia
Primary sponsor type
Individual
Name
Individual (Michael Paech)
Address
Department of Anaesthesia and Pain medicine, king Edward memorial Hospital for women, 374 bagot rd, Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 1520 0
None
Name [1] 1520 0
None
Address [1] 1520 0
Country [1] 1520 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3180 0
King Edward Memorial Hospital for Women
Ethics committee address [1] 3180 0
Ethics committee country [1] 3180 0
Australia
Date submitted for ethics approval [1] 3180 0
Approval date [1] 3180 0
05/09/2006
Ethics approval number [1] 3180 0
EC06-57

Summary
Brief summary
This study will investigate two methods of pain relief after caesarean section conducted under regional anaesthesia. Our hypothesis is that multimodal analgesia including intrathecal morphine is more effective than multimodal analgesia with regular administration of oral opioid.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27422 0
Address 27422 0
Country 27422 0
Phone 27422 0
Fax 27422 0
Email 27422 0
Contact person for public queries
Name 10677 0
Michael Paech
Address 10677 0
Department of Anaesthesia and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Rd
Subiaco WA 6008
Country 10677 0
Australia
Phone 10677 0
+61 8 93402222
Fax 10677 0
+61 8 93402260
Email 10677 0
michael.paech@health.wa.gov.au
Contact person for scientific queries
Name 1605 0
Michael Paech
Address 1605 0
Department of Anaesthesia and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Rd
Subiaco WA 6008
Country 1605 0
Australia
Phone 1605 0
+61 8 93402222
Fax 1605 0
+61 8 93402260
Email 1605 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

Documents added manually
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Documents added automatically
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