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

Primary Purpose

Analgesia, Obstetrical, Post-Dural Puncture Headache

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Resiting Epidural Catheter
Intrathecal Catheter Placement
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia, Obstetrical focused on measuring Labor Pain, Obstetric Labor Complications, Analgesia, Epidural

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Confirmed diagnosis of UDP during labour Written informed consent Exclusion Criteria: Refusal to participate in the study History of PDPH

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Resiting Epidural Catheter

    Intrathecal catheter placement

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    PDPH intensity at 24 hours
    PDPH intensity, rated using a 10-point scale, ranging from 0 ("no pain") to 10 ("worst pain imaginable")
    PDPH intensity at 48 hours
    PDPH intensity, rated using a 10-point scale, ranging from 0 ("no pain") to 10 ("worst pain imaginable")
    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.
    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.
    Chronic pain at 1 month
    Incidence of chronic headache and chronic low back pain
    Chronic pain at 3 months
    Incidence of chronic headache and chronic low back pain
    Readmission to hospital
    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)
    Patient's satisfaction
    Patient's satisfaction, evaluated through the Italian version of the Birth Satisfaction Scale-Revised (BSS-R)

    Full Information

    First Posted
    July 20, 2023
    Last Updated
    August 2, 2023
    Sponsor
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05977361
    Brief Title
    Intrathecal Catheter Placement Versus Resiting Epidural Catheter After Dural Puncture in Obstetric Patients
    Acronym
    ItaREVI
    Official Title
    Intrathecal Catheter Placement Versus Resiting Epidural Catheter After Dural Puncture in Obstetric Patients: a Multicenter Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    November 2025 (Anticipated)
    Study Completion Date
    January 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Analgesia, Obstetrical, Post-Dural Puncture Headache
    Keywords
    Labor Pain, Obstetric Labor Complications, Analgesia, Epidural

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    181 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Resiting Epidural Catheter
    Arm Type
    Active Comparator
    Arm Title
    Intrathecal catheter placement
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Resiting Epidural Catheter
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Intrathecal Catheter Placement
    Intervention Description
    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 Measure Information:
    Title
    PDPH incidence
    Description
    Incidence of post-dural puncture headache (PDPH) at 24 hours from UDP occurrence
    Time Frame
    At 24 hours from UDP
    Secondary Outcome Measure Information:
    Title
    PDPH intensity at 24 hours
    Description
    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
    Title
    PDPH intensity at 48 hours
    Description
    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
    Title
    Quality of analgesia
    Description
    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
    Title
    Adverse events
    Description
    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
    Title
    Chronic pain at 1 month
    Description
    Incidence of chronic headache and chronic low back pain
    Time Frame
    At 1 month from UDP
    Title
    Chronic pain at 3 months
    Description
    Incidence of chronic headache and chronic low back pain
    Time Frame
    At 3 months from UDP
    Title
    Readmission to hospital
    Description
    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)
    Time Frame
    Up to 3 months from UDP
    Title
    Patient's satisfaction
    Description
    Patient's satisfaction, evaluated through the Italian version of the Birth Satisfaction Scale-Revised (BSS-R)
    Time Frame
    Before discharge, an average of 1 week

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Confirmed diagnosis of UDP during labour Written informed consent Exclusion Criteria: Refusal to participate in the study History of PDPH
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bruno A Zanfini, MD, PhD
    Phone
    06 3015 3105
    Email
    brunoantonio.zanfini@policlinicogemelli.it

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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