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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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

Study type
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

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
Secondary outcome [2] 8225 0
Number of attempts to locate epidural space
Timepoint [2] 8225 0
Secondary outcome [3] 8226 0
Time taken to locate epidural space
Timepoint [3] 8226 0
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
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

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
Can healthy volunteers participate?
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
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
Other design features
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
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
Address [1] 3893 0
Australian Society of Anaesthetists
Suite 603 Eastpoint Tower
180 Ocean Street
NSW 2027
Country [1] 3893 0
Primary sponsor type
King Edward Memorial Hospital for Women
374 Bagot Road
WA 6008
Secondary sponsor category [1] 3495 0
Name [1] 3495 0
Address [1] 3495 0
Country [1] 3495 0

Ethics approval
Ethics application status
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
WA 6008
Ethics committee country [1] 5944 0
Date submitted for ethics approval [1] 5944 0
Approval date [1] 5944 0
Ethics approval number [1] 5944 0

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

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
WA 6008
Country 12105 0
Phone 12105 0
+61 8 9340 2200
Fax 12105 0
+61 8 9340 2227
Email 12105 0
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
WA 6008
Country 3033 0
Phone 3033 0
+61 8 9340 2200
Fax 3033 0
+61 8 9340 2227
Email 3033 0

No information has been provided regarding IPD availability
Summary results
No Results