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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Post-Dural Puncture Headache; Analgesia, Obstetrical
• Intervention / Treatment: Procedure: Resiting Epidural Catheter; Procedure: Intrathecal Catheter Placement

• Study Type: Interventional
• Enrollment (Estimated): 181
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bruno A Zanfini, MD, PhD; Phone Number: 06 3015 3105; Email: brunoantonio.zanfini@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Confirmed diagnosis of UDP during labour
• Written informed consent

Exclusion Criteria:

• Refusal to participate in the study
• History of PDPH

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Resiting Epidural Catheter	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.
Active Comparator: Intrathecal catheter placement	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PDPH incidence	Incidence of post-dural puncture headache (PDPH) at 24 hours from UDP occurrence	At 24 hours from UDP

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PDPH intensity at 24 hours	PDPH intensity, rated using a 10-point scale, ranging from 0 ("no pain") to 10 ("worst pain imaginable")	At 24 hours from UDP
PDPH intensity at 48 hours	PDPH intensity, rated using a 10-point scale, ranging from 0 ("no pain") to 10 ("worst pain imaginable")	At 48 hours from UDP
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.	During the entire course of labour, an average of 12 hours
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.	During the entire follow-up period, up to 3 months from UDP
Chronic pain at 1 month	Incidence of chronic headache and chronic low back pain	At 1 month from UDP
Chronic pain at 3 months	Incidence of chronic headache and chronic low back pain	At 3 months from UDP
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)	Up to 3 months from UDP
Patient's satisfaction	Patient's satisfaction, evaluated through the Italian version of the Birth Satisfaction Scale-Revised (BSS-R)	Before discharge, an average of 1 week

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): April 26, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: July 20, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Obstetric Labor Complications; Labor Pain; Analgesia, Epidural
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Dural Puncture Headache
• Other Study ID Numbers: ItaREVI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No