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

Not Applicable

Not yet recruiting

• Conditions: Analgesia, Obstetrical; Post-Dural Puncture Headache
• Interventions: Procedure: Intrathecal Catheter Placement; Procedure: Resiting Epidural Catheter

• Registration Number: NCT05977361
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-20
• Study First Submitted QC: 2023-08-02
• Study First Posted: 2023-08-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25
• Study Start: 2024-04-26
• Primary Completion: 2026-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 181

Inclusion Criteria

• Confirmed diagnosis of UDP during labour
• Written informed consent

Exclusion Criteria

• Refusal to participate in the study
• History of PDPH

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrathecal catheter placement	Intrathecal Catheter Placement	-
Resiting Epidural Catheter	Resiting Epidural Catheter	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
PDPH intensity at 24 hours	At 24 hours from UDP	PDPH intensity, rated using a 10-point scale, ranging from 0 ("no pain") to 10 ("worst pain imaginable")
PDPH intensity at 48 hours	At 48 hours from UDP	PDPH intensity, rated using a 10-point scale, ranging from 0 ("no pain") to 10 ("worst pain imaginable")
Chronic pain at 1 month	At 1 month from UDP	Incidence of chronic headache and chronic low back pain
Chronic pain at 3 months	At 3 months from UDP	Incidence of chronic headache and chronic low back pain
Readmission to hospital	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)
Quality of analgesia	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.
Adverse events	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.
Patient's satisfaction	Before discharge, an average of 1 week	Patient's satisfaction, evaluated through the Italian version of the Birth Satisfaction Scale-Revised (BSS-R)