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
About this trial
This is an interventional treatment trial for Analgesia, Obstetrical focused on measuring Labor Pain, Obstetric Labor Complications, Analgesia, Epidural
Eligibility Criteria
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
NCT ID
NCT05977361
First Posted
July 20, 2023
Last Updated
August 2, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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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