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Inadvertant dural puncture in labour: Intrathecal Catheter versus Epidural (The ICE Pilot Study)

Dural puncture in labour: Intrathecal Catheter versus Epidural (The ICE Pilot Study) to prevent the need for epidural blood patch

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000009314
Acronym
The "ICE" Pilot Study
Enrollment
12
Registered
2008-01-10
Start date
2008-08-01
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

Interventions

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

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.

Sponsors

Allan M Cyna
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
16 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

Women in labour who experience an inadvertent dural puncture during attempt at regional analgesia

Exclusion criteria

A trained anaesthetist unavailable to manage complications of regional anaesthesia; contra-indications for epidural placement

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026