Clinical Trial Results:
Comparison of the ED95 dose of 0.075% and 0.1% bupivacaine for labour analgesia in primigravida
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Summary
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EudraCT number |
2010-020020-21 |
Trial protocol |
GB |
Global end of trial date |
14 Apr 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
11 Apr 2020
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First version publication date |
11 Apr 2020
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Other versions |
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Summary report(s) |
Trial Terminated before Recruiting Statement |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
AN10/9307
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
University of Leeds
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Sponsor organisation address |
Worsley Building, Leeds, United Kingdom, LS2 9JT
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Public contact |
Dr Anurag Vats, University of Leeds, 0113 2060440, a.vats@nhs.net
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Scientific contact |
Dr Anurag Vats, University of Leeds, 0113 2060440, a.vats@nhs.net
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
14 Apr 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
14 Apr 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
14 Apr 2016
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
What is the dose of bupivacaine 0.075% and bupivacaine 0.1% that has 95% chance of success for epidural pain relief, during early part of labour, for a woman having first child.
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Protection of trial subjects |
All primigravida women admitted to the labour ward will be given patient information leaflet on arrival. When they will request epidural anaesthesia, the stage of labour will be identified by the obstetric registrar in collaboration with midwives on call. The time between arrival on the ward and request for epidural is very variable and from our experiences it ranges between 30 minutes to 8 hours. The primigravida woman who will be in early labour will be approached for consent and assenting patients will be randomised to receive either 0.075% or 0.1% bupivacaine using sealed envelope method. The randomisation will be done by an independent person not connected to the trial.
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Background therapy |
Local anaesthetics can cause toxicity by an absolute overdose, intravenous injection or slow intravascular absorption from the site of injection. In most cases, rates of severe systemic toxicity (seizures with or without cardiac arrest) occur in the order of 1:1000 for peripheral nerve blocks1 and 1:10,000 for epidurals2-3. The risk of toxicity when performing regional anaesthesia can be reduced significantly by injecting the optimal amount of local anaesthetic at the correct site. | ||
Evidence for comparator |
Fentanyl is regularly added to the loading dose of the bupivacaine for labour analgesia as it has been conclusively shown to reduce the dose, autonomic and motor side effects of the local anaesthetics required. Epidural fentanyl (40 µg) has been proven to have a significant local anaesthetic–sparing effect when used with levo-bupivacaine for epidural analgesia in early labour16, 17. It reduces the side effects associated with higher concentration of local anaesthetic agents | ||
Actual start date of recruitment |
30 Jan 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 99999
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Worldwide total number of subjects |
99999
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EEA total number of subjects |
99999
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
99999
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Pregnant women are admitted to the labour ward when they go into labour. Depending upon the patient, they might be either in early labour or late labour. The stage of labour is decided by the cervical dilatation and the frequency of uterine contractions. For our study, only primigravida woman in early labour will be recruited. | |||||||||
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Pre-assignment
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Screening details |
The primigravida woman who will be in early labour will be approached for consent and assenting patients will be randomised to receive either 0.075% or 0.1% bupivacaine using sealed envelope method. | |||||||||
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Period 1
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Period 1 title |
Main Trial Period (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Carer, Assessor | |||||||||
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Arms
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Are arms mutually exclusive |
No
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Arm title
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0.075% Bupivicaine | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
bupivacaine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Epidural use
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Dosage and administration details |
The operator will inject the study drug in the epidural space as part of the standard care.
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Arm title
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0.1% bupivacaine | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
bupivacaine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Epidural use
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Dosage and administration details |
The operator will inject the study drug in the epidural space as part of the standard care.
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Baseline characteristics reporting groups
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Reporting group title |
Main Trial Period
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Reporting group description |
- | |||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
0.075% Bupivicaine
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Reporting group description |
- | ||
Reporting group title |
0.1% bupivacaine
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Reporting group description |
- | ||
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End point title |
Effective starting Dose of bupivacaine [1] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Patients assessed at the time of labor, and followed up once discharged.
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis's were performed, as no data was collected from any participants. |
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| Notes [2] - No Data was collected on any participants, as no patients were randomised onto the study [3] - No Data was collected on any participants, as no patients were randomised onto the study |
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| No statistical analyses for this end point | ||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
Adverse events will be picked up either by the Chief Investigator (CI), the Principal Investigator (PI) or the nursing staff on the wards or the GP following discharge. Adverse events occurring up to 24 hours following administration will be reported.
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||
Dictionary version |
4.0
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| Frequency threshold for reporting non-serious adverse events: 5% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No Adverse events were recorded on the study, as no data was collected from any participants. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| The trial was early terminated due to poor recruitment | |||
