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Trial registered on ANZCTR


Registration number
ACTRN12616001108404
Ethics application status
Approved
Date submitted
19/10/2015
Date registered
16/08/2016
Date last updated
11/06/2019
Date data sharing statement initially provided
11/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing 0.125% and 0.0625% bupivacaine + 2mcg/ml fentanyl for maintenance of epidural labour analgesia on Delivery Unit at National Women's Hospital, Auckland - A feasibility study.
Scientific title
Feasibility study comparing 0.125% and 0.0625% bupivacaine + 2mcg/ml fentanyl for maintenance of labour epidural analgesia to ensure a switch to lower concentrations of local anaesthetic is non-inferior in labouring women on Delivery Unit at National Women's Hospital, Auckland.
Secondary ID [1] 287338 0
Nil
Universal Trial Number (UTN)
U1111-1172-3712
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epidural 295978 0
Labour Analgesia 299870 0
Condition category
Condition code
Reproductive Health and Childbirth 296258 296258 0 0
Childbirth and postnatal care
Anaesthesiology 299774 299774 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this trial is to confirm that a change from the currently used epidural mix of local anaesthetic for labour analgesia in our institution to a lower concentration is non-inferior for maintenance of labour epidural analgesia and confirms the benefits seen in other institutions using these lower concentrations.
We will investigate the use of two different concentrations of epidural local anaesthetic:
Group 1 (first cohort) - 0.125% Bupivacaine mixed with 2mcg/ml fentanyl
Group 2 (second cohort) - 0.0625% bupivacaine mixed with 2mcg/ml fentanyl.
The drug mixture of bupivacaine and fentanyl for each group will be administered by patient controlled epidural analgesia (PCEA) that delivers a fixed volume of the drug mixture with a subsequent lockout where further drugs cannot be administered. The concentration being studied will be given for maintenance of their epidural for the whole of their labour from the time the epidural is established to delivery of the baby. Patient demands will be allowed up to 4 times per hour with one additional midwife-administered bolus possible per hour, and the total dose will be recorded from the pump at the end of the labour, along with the duration of the epidural. All parturients requesting epidural analgesia (other than those patients anticipated to fulfil the exclusion criteria) will be approached to participate in this study.
Only one concentration of epidural drug will be administered per epidural, starting from when the epidural is initially sited and patient comfortable, until birth. The epidural pumps deliver their drugs on patient demand, with a 5 minute lockout and maximum 5 doses administered per hour; the 0.125% concentration is a 5 ml bolus, with the 0.0625% concentration a 7ml bolus.
Additional rescue boluses of 10mls 0.125% bupivacaine with 2mcg/ml fentanyl are also available, administered by the anaesthetist, should the patient's epidural pain relief prove inadequate, as frequently as the anaesthetist deems necessary up to the maximum safe local anaesthetic dose for the patient (2mg/kg Bupivacaine every 4 hours). Duration of epidural and total dose administered are used to monitor drug consumption.
Intervention code [1] 292660 0
Treatment: Drugs
Comparator / control treatment
The comparison group is the currently-used concentration of local anaesthetic used for maintenance of epidural analgesia at our institution. This is 0.125% bupivacaine with 2mcg/ml fentanyl as patient controlled epidural analgesia (PCEA).
Control group
Dose comparison

Outcomes
Primary outcome [1] 295918 0
Number of staff interventions required for inadequate epidural analgesia, (i.e. where the anaesthetist has to return to troubleshoot the epidural because of inadequate analgesia or other epidural-related side effects such as high block, hypotension - normally the anaesthetist should not need to return to the room but this occurs in 5-30% of epidurals). This is noted on the data sheet contemporaneously and will be verified against clinical notes after birth.
Timepoint [1] 295918 0
Any time whilst labour epidural is in progress.
Primary outcome [2] 295919 0
Percentage of patients satisfied with their labour epidural (classified according to a five-item Likert score of strongly disagree, disagree, neutral, agree, strongly agree).
Timepoint [2] 295919 0
Outcome collected at patient follow-up on next working day post delivery.
Primary outcome [3] 297496 0
Pain scores (score/10 using verbal numerical pain scale of 0-10).
Timepoint [3] 297496 0
Outcome collected at 1,3,5 and 7 hours after patient controlled epidural analgesia with studied local anaesthetic concentration commenced.
Secondary outcome [1] 316919 0
Epidural sensory distribution, using dermatome chart.
Timepoint [1] 316919 0
Outcome collected at 1,3,5 and 7 hours after patient controlled epidural analgesia with studied local anaesthetic concentration commenced.

All secondary outcomes are separate
Secondary outcome [2] 316920 0
Bromage (motor) scores using illustrated Bromage scale of ability of patient to straight leg raise.
Timepoint [2] 316920 0
Outcome collected at 1,3,5 and 7 hours after patient controlled epidural analgesia with studied local anaesthetic concentration commenced.
Secondary outcome [3] 316921 0
Patient's subjective ability to walk during early labour and just prior to commencement of second stage of labour. Yes/No answer to "I felt I could walk around"
Timepoint [3] 316921 0
Outcome collected at patient follow-up on next working day post delivery. Timepoints are a retrospective recollection by the patient at this follow up, early in labour when their epidural was running and just prior to beginning the second (pushing) stage of labour.
Secondary outcome [4] 316923 0
Percentage of parturients undergoing normal vaginal delivery
Timepoint [4] 316923 0
Outcome determined on r/v of pateint notes post delivery
Secondary outcome [5] 318327 0
Requirement for urinary catheterisation in labour
Timepoint [5] 318327 0
Determined from notes review post delivery
Secondary outcome [6] 318330 0
Quality of epidural if topped-up as routine for operative theatre intervention
Timepoint [6] 318330 0
Outcome determined on follow up of patient next day (classified according to a five-item Likert score of strongly disagree, disagree, neutral, agree, strongly agree)
Secondary outcome [7] 326613 0
Patient's subjective ability to move themselves in bed early in their labour and just before the second stage of labour. Yes/No answer to "I felt I could move in bed"
Timepoint [7] 326613 0
Outcome collected at patient follow-up on next working day post delivery.Timepoints are a retrospective recollection by the patient at this follow up, early in labour when their epidural was running and just prior to beginning the second (pushing) stage of labour.
Secondary outcome [8] 326719 0
Patient's subjective ability to stand up during early labour and just prior to commencement of second stage of labour. Yes/No answer to "I felt I could stand up"
Timepoint [8] 326719 0
Outcome collected at patient follow-up on next working day post delivery. Timepoints are a retrospective recollection by the patient at this follow up, early in labour when their epidural was running and just prior to beginning the second (pushing) stage of labour.

Eligibility
Key inclusion criteria
All patients on Delivery Unit who undergo epidural analgesia for labour are eligible for recruitment, unless they fulfil any of the limited exclusion criteria listed below.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Women undergoing epidural insertion out of hours
2) Women thought likely to deliver within the forthcoming 2 hours
3) Women whose lead maternity carer (LMC) is not in agreement for epidural maintenance with a patient-controlled pump

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients receive drug concentration depending on month of study
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data collection will be observational in nature. Data will therefore be analysed with comparisons of medians and interquartile ranges using ANOVA to determine any statistical significance between the groups.
From published data, staff intervention rates for suboptimal epidurals of a similar concentration are 31%, so for 100 patients in each group we will have sufficient power (80%) to show a 60% increase or more in the rate of interventions for suboptimal analgesia with the more dilute epidural mixture.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2016
Actual
1/12/2016
Date of last participant enrolment
Anticipated
31/12/2018
Actual
8/05/2019
Date of last data collection
Anticipated
1/01/2019
Actual
31/05/2019
Sample size
Target
200
Accrual to date
Final
200
Recruitment outside Australia
Country [1] 7255 0
New Zealand
State/province [1] 7255 0
Auckland

Funding & Sponsors
Funding source category [1] 292246 0
Charities/Societies/Foundations
Name [1] 292246 0
Auckland District Health Board Anaesthesia Research Trust
Country [1] 292246 0
New Zealand
Primary sponsor type
Government body
Name
Auckland District Health Board
Address
Auckland City Hospital,
Department of Anaesthesia - Level 9,
Private Bag 92024, Auckland Mail Centre,
Auckland 1142.
New Zealand.
Country
New Zealand
Secondary sponsor category [1] 290923 0
None
Name [1] 290923 0
N/A
Address [1] 290923 0
N/A
Country [1] 290923 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293710 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 293710 0
Health and Disability Ethics Committees
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 293710 0
New Zealand
Date submitted for ethics approval [1] 293710 0
30/09/2015
Approval date [1] 293710 0
25/02/2016
Ethics approval number [1] 293710 0
15/STH/183

Summary
Brief summary
This is an interventional trial with the aim of determining the feasibility of changing to a lower concentration of local anaesthetic within our population of parturients choosing epidural analgesia for labour. There is well established evidence for the use of lower concentration local anaesthetic mixtures, and 0.0625% has been successfully used in our and other centres. A reduction in the concentration of local anaesthetic for labour epidural analgesia has both maternal and fetal benefits, including lower total local anaesthetic consumption during labour, improved mobility and increased likelihood of spontaneous vaginal delivery. As a result, the multidisciplinary team at National Women's Hospital, are keen to explore the feasibility of changing from the currently used "standard mix" 0.125% bupivacaine + 2mcg/ml fentanyl to exclusive use of a lower local anaesthetic concentration.
This feasibility study will allocate women to undergo maintenance of epidural analgesia for labour using one of the two currently used mixtures of epidural drugs: 0.125% bupivacaine + 2mcg/ml fentanyl or 0.0625% bupivacaine, each with 2mcg/ml fentanyl, depending on the month of study. Epidural insertion, testing and loading will commence as per the inserting anaesthetist's normal practice. The epidural in each study arm will then be maintained with the relevant study concentration of local anaesthetic via PCEA. Outcome measures will include satisfaction with labour analgesia, requirement for additional top-ups or other staff interventions, total local anaesthetic dosages administered, duration of labour. mode of delivery, adequacy of analgesia for delivery, extent of motor blockade during labour and rates of urinary catheterisation.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 785 785 0 0
/AnzctrAttachments/369180-HDEC approval letter epidural study.pdf
Attachments [2] 1012 1012 0 0
/AnzctrAttachments/369180-EpiduralStudy-Protocol Version8Aug 2016.docx
Attachments [3] 1013 1013 0 0
/AnzctrAttachments/369180(v09-08-2016-19-56-07)-Patient Info Sheet Aug 6 2016.docx

Contacts
Principal investigator
Name 59778 0
Dr Matthew Drake
Address 59778 0
Department of Anaesthesia - Level 9,
Auckland City Hospital
Private Bag 92024, Auckland Mail Centre,
Auckland 1142.
New Zealand.
Country 59778 0
New Zealand
Phone 59778 0
+ 64 9 307 4949 x25026
Fax 59778 0
Email 59778 0
[email protected]
Contact person for public queries
Name 59779 0
Matthew Drake
Address 59779 0
Department of Anaesthesia - Level 9,
Auckland City Hospital
Private Bag 92024, Auckland Mail Centre,
Auckland 1142.
New Zealand.
Country 59779 0
New Zealand
Phone 59779 0
+ 64 9 307 4949 x25026
Fax 59779 0
Email 59779 0
[email protected]
Contact person for scientific queries
Name 59780 0
Matthew Drake
Address 59780 0
Department of Anaesthesia - Level 9,
Auckland City Hospital
Private Bag 92024, Auckland Mail Centre,
Auckland 1142.
New Zealand.
Country 59780 0
New Zealand
Phone 59780 0
+64 9 307 4949 x25026
Fax 59780 0
Email 59780 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Outcomes are aggregated. Raw data will be available on request to scientific reveiwers but not made publically available, except for selected free text comments from participants.


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.