ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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.

Condition category

Condition code

Reproductive Health and Childbirth

Normal pregnancy

Alternative and Complementary Medicine

Pain management

Surgery

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]

None

Comparator / control treatment

Saline as a placebo

Control group

Active

Outcomes

Primary outcome [1]

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]

Assessed at 18 hours (just prior to crossover) and at 36 hours

Secondary outcome [1]

Pain score (0-100 visual analogue scale - VAS) and side effects (nausea, pruritus, sedation).

Timepoint [1]

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]

Requirment for resuce analgesia

Timepoint [2]

During each of 1st and 2nd 18 hour periods.

Secondary outcome [3]

Quality of Recovery Sore, Modified Brief Pain Inventory Score & Health Outcomes Recovery Survey

Timepoint [3]

At 18 and 36 hours.

Secondary outcome [4]

Physical assessment of infant to assess tone and alertness.

Timepoint [4]

At 18 hours

Secondary outcome [5]

A subgroup of 20 patients will have a series of blood samples taken for pharmacokinetic studies.

Timepoint [5]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

ANZCA 2005 Research Grant

Address [1]

Country [1]

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]

Individual

Name [1]

Professor Ken Ilett

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

King Edward Memorial Hospital for Women

Ethics committee address [1]

374 Bagot Road, Subiaco, Perth, WA, 6008

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Professor Michael Paech or Research Nurses, Desiree Cavill or Tracy Bingham

Address

King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco Perth WA 6008

Country

Australia

Phone

+61 8 93402222 Pager 3223 (Mike Paech) or 3433 (Research Nurses)

Fax

+61 8 93402260

Michael.Paech@health.wa.gov.au

Contact person for scientific queries

Name

Professor Michael Paech

Address

King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco Perth WA 6008

Country

Australia

Phone

+61 8 93402222 Pager 3223

Fax

+61 8 93402260

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

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically