Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000327684
Ethics application status
Approved
Date submitted
5/09/2005
Date registered
7/09/2005
Date last updated
7/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nasal versus Epidural Fentanyl for Patient Controlled Analgesia after Caesarean Section
Scientific title
A Randomised Double Blind Crossover Trial of Intransal Versus Epidural Fentanyl Patient Controlled Analgeisa for Pain Relief after Caesarean Section
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative pain following caesarean section. 415 0
Condition category
Condition code
Reproductive Health and Childbirth 486 486 0 0
Normal pregnancy
Alternative and Complementary Medicine 487 487 0 0
Pain management
Surgery 488 488 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fentanyl is suitable for patient controlled epidural analgesia (PCEA) after caesarean section. Regional techniques are however contra-indicated in some women and others have the epidural removed at the end of the operation because of concern about infection or bleeding risks; in some women the epidural may become dislodged early. Analgesia is then provided with oral or intravenous medications. A new patient-controlled analgesia pump has been made that allows a patient to give themselves analgesia (fentanyl) as a nasal spray (PCNA). This study will compare PCEA and PCNA, to see whether PCNA is a reliable alternative method of pain relief after caesarean section. We aim to recruit women scheduled for an elective caesarean section under combined spinal epidural anaesthesia. The anaesthetic technique will be standardised. At the end of the procedure, over two consecutive 18 hour periods, participants will self-administer epidural fentanyl during one period and intranasal fentanyl during the other. The order will be randomised. To blind the study, patients will be given both an epidural and a nasal patient-controlled device and will be asked to press both each time they require pain relief (one will contain fentanyl, the other saline as a placebo). Regular paracetamol will be given and other oral medication is available if required.
Intervention code [1] 349 0
None
Comparator / control treatment
Saline as a placebo
Control group
Active

Outcomes
Primary outcome [1] 557 0
Patient rating of satisfaction (as a percentage and using the following scale: dissatisfied, somewhat dissatisfied, neither satisfied nor dissatisfied, somewhat satisfied, satisfied) with the method of pain relief
Timepoint [1] 557 0
Assessed at 18 hours (just prior to crossover) and at 36 hours
Secondary outcome [1] 1179 0
Pain score (0-100 visual analogue scale - VAS) and side effects (nausea, pruritus, sedation).
Timepoint [1] 1179 0
Assessed at regular intervals during the 36 hours (pain scores taken from time of first activation of PCA devices at 5, 15, 30, 60 minutes and 4, 8, 12, 18, 22, 26, 30 and 36 hours; side effects to be assessed at 18 hours just prior to crossover and at 36 hours).
Secondary outcome [2] 1180 0
Requirment for resuce analgesia
Timepoint [2] 1180 0
During each of 1st and 2nd 18 hour periods.
Secondary outcome [3] 1181 0
Quality of Recovery Sore, Modified Brief Pain Inventory Score & Health Outcomes Recovery Survey
Timepoint [3] 1181 0
At 18 and 36 hours.
Secondary outcome [4] 1182 0
Physical assessment of infant to assess tone and alertness.
Timepoint [4] 1182 0
At 18 hours
Secondary outcome [5] 1183 0
A subgroup of 20 patients will have a series of blood samples taken for pharmacokinetic studies.
Timepoint [5] 1183 0
At 4, 8, 18, 22, 26 and 36 hours from time of first activation of PCEA pumps.

Eligibility
Key inclusion criteria
.Scheduled for elective or non-urgent Caesarean section under combined spinal-epidural anaesthesia and consenting to use patient-controlled analgesia.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Anaesthesia other than combined spinal-epiduralUnsuitable for postoperative epidural analgesia or patient-controlled analgesiaAllergy or intolerance to fentanylCurrent opioid or magnesium therapyHistory of nasal pathologyMajor surgical complication rendering use of patient-controlled techniques inappropriate.

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)
Drugs prepared by pharmacy so medical and nursing staff and patient remain blind - each epidural solution and nasal spray labelled simply 1 (first 18 hour period) or 2 (second 18 hour period)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random sequence using Scramble Random Numbering System software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 552 0
Other Collaborative groups
Name [1] 552 0
ANZCA 2005 Research Grant
Country [1] 552 0
Primary sponsor type
Individual
Name
Professor Michael Paech
Address
King Edward Memorial Hospital
374 Bagot Road
Subiaco
Perth WA 6008
Country
Australia
Secondary sponsor category [1] 446 0
Individual
Name [1] 446 0
Professor Ken Ilett
Address [1] 446 0
Country [1] 446 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1564 0
King Edward Memorial Hospital for Women
Ethics committee address [1] 1564 0
374 Bagot Road, Subiaco, Perth, WA, 6008
Ethics committee country [1] 1564 0
Australia
Date submitted for ethics approval [1] 1564 0
Approval date [1] 1564 0
Ethics approval number [1] 1564 0

Summary
Brief summary
Fentanyl is a morphine-like pain relieving drug used for pain relief after caesarean section. In our institution most patients have "patient-controlled epidural analgesia" (PCEA) following routine or emergency caesarean section. PCEA allows the patient to give themselves small doses of drug safely by pressing a button on a pump whenever the pain is more than they find acceptable. However, not all women are suitable for an epidural. In some other cases, the epidural is removed straight after the operation because of concern about infection or bleeding risks, sometimes the epidural catheter falls out early on. Pain relief in these cases is usually provided with oral medications and/or an intravenous patient controlled analgesia pump (PCIA). Recently a patient-controlled analgesia pump has been made that allows a patient to give themselves a pain relieving drug, for example fentanyl, as a nasal spray; this method is called "patient-controlled intranasal analgesia" or PCNA. The aim of this study is to compare PCEA and PCNA, to see whether PCNA could be a reliable alternative method of pain relief after caesarean section. This study will compare two methods of pain relief after caesarean section. Patients will, over two consecutive 18 hour time periods, self-administer epidural fentanyl for one period and intranasal fentanyl for the other. The order in which the fentanyl is used will be randomised (i.e. based on a toss of a coin), so each patient may receive either epidural or nasal fentanyl first. After 18 hours, this will changed around. However, to "blind" the study (a means of making sure the results are more reliable), patients will be given both an epidural and a nasal patient controlled analgesia pump; they will be asked to press both each time they need some more medication; and they will not be told which one contains fentanyl (the other will contain saline solution, a "placebo". This means patients will be unaware as to whether the fentanyl is being given into the epidural or the nose.
At regular intervals during the 36 hours of the study, patients will be asked about pain relief, side effects (for example, feeling sick or drowsy), recovery from the operation and satisfaction. Patients will also receive regular paracetamol tablets for pain relief, and other tablet pain relief is available if required. In all other respects, patients will be looked after routinely. Because we also want to know what the blood levels of fentanyl are, we need to take a series of small blood samples at 8 times during the 36 hours of the study period. The age, weight and general well-being of the baby will also be assessed. This will include a painless clinical examination of the baby's alertness. The entire examination should not take more than 10 minutes and will be performed by a paediatrician or anaesthetic research doctor. This will take place at the end of the first study period (at about 18 hours after operation).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35685 0
Address 35685 0
Country 35685 0
Phone 35685 0
Fax 35685 0
Email 35685 0
Contact person for public queries
Name 9538 0
Professor Michael Paech or Research Nurses, Desiree Cavill or Tracy Bingham
Address 9538 0
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco Perth WA 6008
Country 9538 0
Australia
Phone 9538 0
+61 8 93402222 Pager 3223 (Mike Paech) or 3433 (Research Nurses)
Fax 9538 0
+61 8 93402260
Email 9538 0
[email protected]
Contact person for scientific queries
Name 466 0
Professor Michael Paech
Address 466 0
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco Perth WA 6008
Country 466 0
Australia
Phone 466 0
+61 8 93402222 Pager 3223
Fax 466 0
+61 8 93402260
Email 466 0
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.