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

ConditionsAnalgesia, ObstetricalPost-Dural Puncture Headache
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed diagnosis of UDP during labour

Written informed consent

Disqualifiers

Refusal to participate in the study

History of PDPH

Trial design

Design model

Parallel

Treatments tested in this trial

  • Resiting Epidural Catheter

    Procedure/Surgery

    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.

  • Intrathecal Catheter Placement

    Procedure/Surgery

    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.

Treatment groups

181 Participants
are divided into 2 treatment groups
Group A: Resiting Epidural CatheterActive comparator 1 intervention
Group B: Intrathecal catheter placementActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

PDPH incidence

Incidence of post-dural puncture headache (PDPH) at 24 hours from UDP occurrence

Time frame
At 24 hours from UDP

Secondary outcomes

1

PDPH intensity at 24 hours

PDPH intensity, rated using a 10-point scale, ranging from 0 ("no pain") to 10 ("worst pain imaginable")

Time frame
At 24 hours from UDP
2

PDPH intensity at 48 hours

PDPH intensity, rated using a 10-point scale, ranging from 0 ("no pain") to 10 ("worst pain imaginable")

Time frame
At 48 hours from UDP
3

Quality of analgesia

Quality of analgesia during labour will be evaluated, based on the number of additional boluses of local anesthetic administered during labour to treat breakthrough pain.

Time frame
During the entire course of labour, an average of 12 hours
4

Adverse events

All reported adverse events, including number of unsuccessful attempts at placing the epidural or subarachnoid catheter, motor block, poor analgesia, caesarean section rate.

Time frame
During the entire follow-up period, up to 3 months from UDP

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: