Advice

Summary

Summary

The Epidrum is intended for use in combination with a luer syringe and an epidural needle. It is designed to give a visual signal when the epidural space is reached. Two randomised controlled trials found that the Epidrum reduced the time needed to identify the epidural space and increased operator satisfaction. A single‑use Epidrum device costs between £5.70 and £7.20, in addition to a standard epidural needle.

Product summary and likely place in therapy

  • The Epidrum is a single‑use device that is placed between a luer syringe and epidural needle.

  • It provides the user with a visual signal when the epidural needle enters the epidural space.

  • The Epidrum is intended to be used in secondary care, to help trained clinicians access the epidural space to administer epidural medication.

Effectiveness and safety

  • Two randomised controlled trials investigated the efficacy and safety of the Epidrum compared with conventional loss of resistance techniques. In the first trial (n=108), the Epidrum was used during combined spinal–epidural anaesthesia. In the second trial, the Epidrum was used in people who were scheduled to have epidural anaesthesia only (n=80). In both studies the use of the Epidrum statistically significantly reduced the time needed to identify the epidural space, and statistically significantly increased operator satisfaction.

  • There was no statistically significant difference in the incidence of adverse events between the Epidrum and control groups in either study. Two episodes of dural puncture were reported in the 94 people in the control groups of both studies combined, although neither study was powered to detect a difference between the Epidrum and control.

Technical factors

  • The Epidrum is based on the loss of resistance technique for identifying the epidural space. The user inflates the diaphragm by injecting 1 to 3 ml of air into the device. When the tip of the needles enters the epidural space the diaphragm deflates.

Cost and resource use

  • Epidrum is available in packs of 10 or 100. The cost of a pack of 10 is £72 (£7.20 per unit) and of a pack of 100 is £570 (£5.70 per unit), excluding VAT.

  • Since Epidrum is used with a luer syringe and an epidural needle (£3.82 per unit [syringe and needle] excluding VAT), the highest cost of treatment is estimated to be £11.02 per procedure. By comparison, a conventional LOR syringe and epidural needle costs £6.15 per unit (syringe and needle), excluding VAT.

  • No evidence on cost and resource use was available.