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NCT Number: NCT05977361

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

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.

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Key information

Conditions

Analgesia, Obstetrical Agnosia Brain Diseases Central Nervous System Diseases Female Urogenital Diseases and Pregnancy Complications Headache Disorders Headache Disorders, Secondary Labor Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Obstetric Labor Complications Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Post-Dural Puncture Headache Pregnancy Complications Signs and Symptoms Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed diagnosis of UDP during labour
  • Written informed consent

Exclusion criteria

  • Refusal to participate in the study
  • History of PDPH

Treatment and study plan

Resiting Epidural Catheter

Procedure

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

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 outcomes

  1. PDPH incidence

    Time frame: At 24 hours from UDP

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

Secondary outcomes

  1. PDPH intensity at 24 hours

    Time frame: At 24 hours from UDP

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

  2. PDPH intensity at 48 hours

    Time frame: At 48 hours from UDP

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

  3. Quality of analgesia

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

    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.

  4. Adverse events

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

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

  5. Chronic pain at 1 month

    Time frame: At 1 month from UDP

    Incidence of chronic headache and chronic low back pain

  6. Chronic pain at 3 months

    Time frame: At 3 months from UDP

    Incidence of chronic headache and chronic low back pain

  7. Readmission to hospital

    Time frame: Up to 3 months from UDP

    ER visits or hospital readmissions due to neurological symptoms related or possibly related to PDPH (severe headache, severe back pain, fever, leg weakness, incontinence of urine or stool)

  8. Patient's satisfaction

    Time frame: Before discharge, an average of 1 week

    Patient's satisfaction, evaluated through the Italian version of the Birth Satisfaction Scale-Revised (BSS-R)

Study contacts

Contact information is provided by the study sponsor or research team.

Bruno A Zanfini, MD, PhD

CONTACT

[email protected]

06 3015 3105

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Intrathecal Catheter Placement Versus Resiting Epidural Catheter After Dural Puncture in Obstetric Patients: a Multicenter Randomized Controlled Trial

Acronym: ItaREVI

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 4, 2023
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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