Intrathecal Catheter Placement Versus Resiting Epidural Catheter After Dural Puncture in Obstetric Patients: a Multicenter Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Analgesia, Obstetrical
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Enrollment
- 181
- Primary Endpoint
- PDPH incidence
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Confirmed diagnosis of UDP during labour
- •Written informed consent
Exclusion Criteria
- •Refusal to participate in the study
- •History of PDPH
Outcomes
Primary Outcomes
PDPH incidence
Time Frame: At 24 hours from UDP
Incidence of post-dural puncture headache (PDPH) at 24 hours from UDP occurrence
Secondary Outcomes
- PDPH intensity at 24 hours(At 24 hours from UDP)
- PDPH intensity at 48 hours(At 48 hours from UDP)
- Chronic pain at 1 month(At 1 month from UDP)
- Chronic pain at 3 months(At 3 months from UDP)
- Readmission to hospital(Up to 3 months from UDP)
- Quality of analgesia(During the entire course of labour, an average of 12 hours)
- Adverse events(During the entire follow-up period, up to 3 months from UDP)
- Patient's satisfaction(Before discharge, an average of 1 week)