Intrathecal Catheter Placement Versus Resiting Epidural Catheter After Dural Puncture in Obstetric Patients (ItaREVI)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Post-Dural Puncture Headache; Analgesia, Obstetrical

Treatments: Procedure: Intrathecal Catheter Placement; Procedure: Resiting Epidural Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT05977361

ItaREVI

Details and patient eligibility

About

Epidural anesthesia represents the most popular method for pain relief during labour. Unintentional dural puncture (UDP) occurs in 0.4-1.5% of labour epidural analgesia, representing therefore the most common complication. Up to 80% of patients with a UDP may develop a post-dural puncture headache (PDPH).

When a UDP occurs, two possible strategies have been proposed in order to ensure analgesia during labour: either resiting the epidural catheter in a different intervertebral space, or inserting an intrathecal catheter. Both strategies proved to equally provide analgesia during labour, but their relative contribution in preventing PDPH is still not known.

The primary aim of this multicenter randomized controlled trial is therefore to compare these two strategies in the occurrence of PDPH at 24 hours from the UDP.

Enrollment: 181 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of UDP during labour
• Written informed consent

Exclusion criteria

• Refusal to participate in the study
• History of PDPH

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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181 participants in 2 patient groups

Resiting Epidural Catheter

Active Comparator group

Treatment:

Procedure: Resiting Epidural Catheter

Intrathecal catheter placement

Active Comparator group

Treatment:

Procedure: Intrathecal Catheter Placement