Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000041257
Ethics application status
Approved
Date submitted
18/09/2008
Date registered
19/01/2009
Date last updated
19/01/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study of the EpiSure syringe vs conventional epidural syringe
Scientific title
Comparison of the EpiSure Autodetect syringe with the conventional loss-of-resistance syringe among parturients in labour: a randomised controlled trial of analgesic proficiency
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Failure of epidural analgesia for labour 3711 0
Condition category
Condition code
Anaesthesiology 3879 3879 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
EpiSure syringe (Indigo Orb, Irvine, CA), a novel spring-loaded epidural syringe for detecting loss-of-resistance to saline during epidural insertion. The syringe is used to locate the epidural space during epidural insertion, and contains up to 6 ml of 0.9% saline.
Intervention code [1] 3425 0
Treatment: Devices
Comparator / control treatment
Conventional Portex syringe (Smiths Medical ASD, Keene, NH) used for epidural insertion using loss-of-resistance to saline. The syringe is used to locate the epidural space during epidural insertion, and can hold up to 10 ml of 0.9% saline.
Control group
Active

Outcomes
Primary outcome [1] 4781 0
Failure to provide adequate analgesia, as determined by assessment of epidural blockade using ice packs, and numeric rating score for pain
Timepoint [1] 4781 0
Effectiveness of pain relief 20 minutes after epidural analgesia
Secondary outcome [1] 8079 0
Incidence of successful epidural insertion with one pass of the epidural needle
Timepoint [1] 8079 0
Immediate
Secondary outcome [2] 8225 0
Number of attempts to locate epidural space
Timepoint [2] 8225 0
Immediate
Secondary outcome [3] 8226 0
Time taken to locate epidural space
Timepoint [3] 8226 0
Immediate
Secondary outcome [4] 8227 0
Incidence of failed analgesia (i.e. no change in pain or worsening pain, with no change in sensation to cold stimulus) as determined by numerical rating score of pain and epidural block assessment with ice pack
Timepoint [4] 8227 0
20 minutes after epidural insertion
Secondary outcome [5] 8228 0
Incidence of inadvertent dural puncture as determined by patient history and examination
Timepoint [5] 8228 0
24 hours after epidural insertion
Secondary outcome [6] 8229 0
Incidence of entry into an epidural vein as determined by aspiration of blood from the epidural catheter
Timepoint [6] 8229 0
Immediate
Secondary outcome [7] 8230 0
Anaesthetists' assessment of the EpiSure syringe determined using brief questionnaire
Timepoint [7] 8230 0
At conclusion of study (either at the end of the anaesthetists participation in the study, such as when they leave this institution, or once all patients have been recruited)
Secondary outcome [8] 8231 0
Incidence of localised back pain at epidural site as determined by numeric rating score for pain
Timepoint [8] 8231 0
24 hours

Eligibility
Key inclusion criteria
Epidural analgesia for labour
American Society of Anesthesiologists (ASA) Classification I to III patients
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Combined spinal and epidural
Fetal abnormality
Contraindication to epidural analgesia
Spinal abnormaility
Body mass index (BMI) above 44

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)
Concealment using opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computeried sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3893 0
Other Collaborative groups
Name [1] 3893 0
Abbott/ASA (Australian Society of Anaesthetists) Research Grant
Country [1] 3893 0
Australia
Primary sponsor type
Hospital
Name
King Edward Memorial Hospital for Women
Address
374 Bagot Road
Subiaco
WA 6008
Country
Australia
Secondary sponsor category [1] 3495 0
None
Name [1] 3495 0
Address [1] 3495 0
Country [1] 3495 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5944 0
Women's and Newborn's Health Service
Ethics committee address [1] 5944 0
Ethics Committee
King Edward Memorial Hospital
374 Bagot Road
Subiaco
WA 6008
Ethics committee country [1] 5944 0
Australia
Date submitted for ethics approval [1] 5944 0
Approval date [1] 5944 0
02/09/2008
Ethics approval number [1] 5944 0
1574/EW

Summary
Brief summary
We intend to evaluate the EpiSure, a new epidural syringe that uses a novel spring-loaded mechanism to locate the correct place in the back for epidural insertion. Early data regarding this device suggests that it may ease the process of inserting an epidural and reduce complications, particularly in anaesthetists who are relatively new to the procedure of epidural insertion.

We will compare effectiveness of pain relief and outcomes in patients whose epidurals are inserted with the EpiSure with those whose epidurals are inserted with traditional syringes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28948 0
Address 28948 0
Country 28948 0
Phone 28948 0
Fax 28948 0
Email 28948 0
Contact person for public queries
Name 12105 0
Dr Neil Muchatuta
Address 12105 0
Research fellow
Department of Anaesthesia and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco
WA 6008
Country 12105 0
Australia
Phone 12105 0
+61 8 9340 2200
Fax 12105 0
+61 8 9340 2227
Email 12105 0
[email protected]
Contact person for scientific queries
Name 3033 0
Professor Michael Paech
Address 3033 0
Department of Anaesthesia and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco
WA 6008
Country 3033 0
Australia
Phone 3033 0
+61 8 9340 2200
Fax 3033 0
+61 8 9340 2227
Email 3033 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.