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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12606000506594 |
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Date of registration:
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07/12/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Oral analgesia compared with intrathecal morphine for pain after caesarean delivery: a randomised controlled trial
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Scientific title:
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Oral oxycodone analgesia compared with intrathecal morphine for pain relief after caesarean delivery: a randomised controlled trial |
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Date of first enrolment:
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21/01/2007 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12606000506594.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Phase 4
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Countries of recruitment
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Australia
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Contacts
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Name:
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Michael Paech
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Address:
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Department of Anaesthesia and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Rd
Subiaco WA 6008
Australia |
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Telephone:
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+61 8 93402222 |
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Email:
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michael.paech@health.wa.gov.au |
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Affiliation:
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Name:
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Michael Paech
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Address:
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Department of Anaesthesia and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Rd
Subiaco WA 6008
Australia |
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Telephone:
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+61 8 93402222 |
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Email:
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michael.paech@health.wa.gov.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Elective or non-elective caesarean section under combined spinal-epidural or spinal anaesthesia American Society of Anesthesiologists classification 1 or 2
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.
Age minimum:
18 Years
Age maximum:
Not stated
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Pain relief after caesarean section;
Pain relief after caesarean section
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Reproductive Health and Childbirth - Other surgery
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Reproductive Health and Childbirth - Pain management
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Intervention(s)
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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.
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Primary Outcome(s)
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Area under the curve at 24 hours for pain scores[At 6,12, 18 and 24 hours postoperatively]
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Secondary Outcome(s)
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Patient satisfaction score [at 24 hours postoperatively]
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Quality of recovery [at 24 hours postoperatively]
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Opioid-related symptom distress scale score [at 24 hours postoperatively]
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Pain on movement [at 12 and 24 hours postoperatively]
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Source(s) of Monetary Support
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Australian and New Zealand College of Anaesthetists Lennard Travers Professorship Grant
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Ethics review
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Status: Approved
Approval date:
Contact:
King Edward Memorial Hospital for Women
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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