Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000009314
Ethics application status
Not yet submitted
Date submitted
17/12/2007
Date registered
10/01/2008
Date last updated
10/01/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Inadvertant dural puncture in labour: Intrathecal Catheter versus Epidural (The ICE Pilot Study)
Scientific title
Dural puncture in labour: Intrathecal Catheter versus Epidural (The ICE Pilot Study) to prevent the need for epidural blood patch
Universal Trial Number (UTN)
Trial acronym
The "ICE" Pilot Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postdural puncture headache 2638 0
Epidural blood patch 2639 0
Condition category
Condition code
Anaesthesiology 2756 2756 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
At the time of inadvertant dural puncture participants allocated to have an intrathecal catheter will have the epidural catheter threaded through the epidural needle into the intrathecal space. The epidural needle is removed and the epidural catheter can now function as an intrathecal catheter as it is left in the intrathecal space and not the epidural space. It is left in situ for 24-48 hours unless there is a clinical indication to remove it earlier. If labour analgesia or surgical anaesthesia is required this can be provided by administering local anaesthetic drugs such as Ropivacaine or Bupivicaine with or without an opioid such as fentanyl down the intrathecal catheter.
Intervention code [1] 2375 0
Prevention
Comparator / control treatment
At the time of inadvertant dural puncture participants allocated to have the epidural resited will have the epidural needle removed from the intrathecal space and resited so that the epidural catheter is placed correctly in the epidural space. It is left in situ until it is no longer needed for labour analgesia or anaesthesia for surgery. It will be removed usually within 48 hours of placement unless there is a clinical indication to remove it earlier/later. If labour analgesia or surgical anaesthesia is required this can be provided by administering local anaesthetic drugs such as Ropivacaine or Bupivicaine with or without an opioid such as fentanyl down the epidural catheter as per the anaesthetist's usual practice
Control group
Active

Outcomes
Primary outcome [1] 3642 0
Number of women receiving an epidural blood patch within 2 weeks of an inadvertent dural puncture
Timepoint [1] 3642 0
Two weeks after randomisation
Secondary outcome [1] 6116 0
Number of women with a diagnosis of Postdural Puncture Headache as documented in the medical or anaesthetic record
Timepoint [1] 6116 0
On the 3rd and 5th day following randomisation
Secondary outcome [2] 6117 0
Length of hospital stay after randomisation
Timepoint [2] 6117 0
On the day of discharge home from hospital

Eligibility
Key inclusion criteria
Women in labour who experience an inadvertent dural puncture during attempt at regional analgesia
Minimum age
16 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
A trained anaesthetist unavailable to manage complications of regional anaesthesia; contra-indications for epidural placement

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Opaque sealed envelopes containing allocation sequence
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 346 0
5006

Funding & Sponsors
Funding source category [1] 2943 0
Self funded/Unfunded
Name [1] 2943 0
Country [1] 2943 0
Primary sponsor type
Individual
Name
Allan M Cyna
Address
Department of Women's Anaesthesia
Women's and Children's Hospital
72 King William Road
Adelaide SA 5006
Country
Australia
Secondary sponsor category [1] 2613 0
None
Name [1] 2613 0
Address [1] 2613 0
Country [1] 2613 0
Secondary sponsor category [2] 2656 0
None
Name [2] 2656 0
Address [2] 2656 0
Country [2] 2656 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4834 0
Women's and Children's Hospital Ethics Committee
Ethics committee address [1] 4834 0
Ethics committee country [1] 4834 0
Australia
Date submitted for ethics approval [1] 4834 0
01/03/2008
Approval date [1] 4834 0
Ethics approval number [1] 4834 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28248 0
Address 28248 0
Country 28248 0
Phone 28248 0
Fax 28248 0
Email 28248 0
Contact person for public queries
Name 11405 0
Dr Allan M Cyna
Address 11405 0
Department of Women's Anaesthesia
Women's and Children's Hospital
72 King William Rd
Adelaide SA 5006
Country 11405 0
Australia
Phone 11405 0
+61 8 81617000
Fax 11405 0
Email 11405 0
[email protected]
Contact person for scientific queries
Name 2333 0
Dr Allan M Cyna
Address 2333 0
Department of Women's Anaesthesia
Women's and Children's Hospital
72 King William Rd
Adelaide SA 5006
Country 2333 0
Australia
Phone 2333 0
+61 8 81617000
Fax 2333 0
Email 2333 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.