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

Post-Dural Puncture Headache Clinical Trial

— ItaREVI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05977361
• Other study ID #: ItaREVI
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 26, 2024
• Est. completion date: November 30, 2026

Study information

• Verified date: July 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Bruno A Zanfini, MD, PhD
• Phone: 06 3015 3105
• Email: brunoantonio.zanfini[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 181
• Est. completion date: November 30, 2026
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of UDP during labour

• Written informed consent

Exclusion Criteria:

• Refusal to participate in the study

• History of PDPH

Related Conditions & MeSH terms

• Analgesia, Obstetrical
• Headache
• Post-Dural Puncture Headache

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PDPH incidence	Incidence of post-dural puncture headache (PDPH) at 24 hours from UDP occurrence	At 24 hours from UDP
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Chronic pain at 1 month	Incidence of chronic headache and chronic low back pain	At 1 month from UDP
Secondary	Chronic pain at 3 months	Incidence of chronic headache and chronic low back pain	At 3 months from UDP
Secondary	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
Secondary	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