Intrathecal Catheter Placement Versus Resiting Epidural Catheter After Dural Puncture in Obstetric Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Resiting Epidural Catheter, Intrathecal Catheter Placement.
- Who it may be relevant to
- Registry conditions: Analgesia, Obstetrical, Post-Dural Puncture Headache. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intrathecal Catheter Placement Versus Resiting Epidural Catheter After Dural Puncture in Obstetric Patients: a Multicenter Randomized Controlled Trial
Overview
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.
Interventions
- Procedure Resiting Epidural Catheter
After a UDP has occurred, epidural catheter will be re-sited in a different intervertebral space. Analgesia will be then maintained according to internal protocol, using PIEB (Programmed Intermittent Epidural Bolus) system. Catheter will be left in place for the first 24-36 hours. - Procedure Intrathecal Catheter Placement
After a UDP has occurred, an intrathecal catheter will be placed through the dural tap. Analgesia will be then maintained according to internal protocol, using PISB (Programmed Intermittent Subarachnoid Bolus) system. Catheter will be left in place for the first 24-36 hours. During this time, a continuous infusion of sterile saline at a rate of 2 mL/h will be maintained. Before removal, an additional bolus of 10 mL of sterile saline will be administered in the intrathecal catheter.
Primary outcome measures
- PDPH incidence [Time frame: At 24 hours from UDP]
Secondary outcome measures (8)
- PDPH intensity at 24 hours [Time frame: At 24 hours from UDP]
- PDPH intensity at 48 hours [Time frame: At 48 hours from UDP]
- Quality of analgesia [Time frame: During the entire course of labour, an average of 12 hours]
- Adverse events [Time frame: During the entire follow-up period, up to 3 months from UDP]
- Chronic pain at 1 month [Time frame: At 1 month from UDP]
- Chronic pain at 3 months [Time frame: At 3 months from UDP]
- Readmission to hospital [Time frame: Up to 3 months from UDP]
- Patient's satisfaction [Time frame: Before discharge, an average of 1 week]
Eligibility criteria
Inclusion criteria
- Confirmed diagnosis of UDP during labour
- Written informed consent
Exclusion criteria
- Refusal to participate in the study
- History of PDPH
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05977361 · ItaREVI