A study of the EpiSure syringe vs conventional epidural syringe

Comparison of the EpiSure Autodetect syringe with the conventional loss-of-resistance syringe among parturients in labour: a randomised controlled trial of analgesic proficiency

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000041257

Enrollment

1000

Registered

2009-01-19

Start date

2008-09-22

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Epidural analgesia for labour American Society of Anesthesiologists (ASA) Classification I to III patients

Exclusion criteria

Combined spinal and epidural Fetal abnormality Contraindication to epidural analgesia Spinal abnormaility Body mass index (BMI) above 44

Outcome results