NCT05977361

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Apr 2024

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Apr 2024Nov 2026

First Submitted

Initial submission to the registry

July 20, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

April 26, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

April 25, 2024

Status Verified

July 1, 2023

Enrollment Period

2.6 years

First QC Date

July 20, 2023

Last Update Submit

April 24, 2024

Conditions

Analgesia, ObstetricalPost-Dural Puncture Headache

Keywords

Labor PainObstetric Labor ComplicationsAnalgesia, Epidural

Outcome Measures

Primary Outcomes (1)

  • PDPH incidence

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

    At 24 hours from UDP

Secondary Outcomes (8)

  • PDPH intensity at 24 hours

    At 24 hours from UDP

  • PDPH intensity at 48 hours

    At 48 hours from UDP

  • Quality of analgesia

    During the entire course of labour, an average of 12 hours

  • Adverse events

    During the entire follow-up period, up to 3 months from UDP

  • Chronic pain at 1 month

    At 1 month from UDP

  • +3 more secondary outcomes

Study Arms (2)

Resiting Epidural Catheter

ACTIVE COMPARATOR
Procedure: Resiting Epidural Catheter

Intrathecal catheter placement

ACTIVE COMPARATOR
Procedure: Intrathecal Catheter Placement

Interventions

Resiting Epidural CatheterPROCEDURE

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.

Resiting Epidural Catheter
Intrathecal Catheter PlacementPROCEDURE

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.

Intrathecal catheter placement

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of UDP during labour
  • Written informed consent

You may not qualify if:

  • Refusal to participate in the study
  • History of PDPH

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AgnosiaPost-Dural Puncture HeadacheLabor PainObstetric Labor Complications

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHeadache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesPainPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Bruno A Zanfini, MD, PhD

CONTACT

06 3015 3105brunoantonio.zanfini@policlinicogemelli.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2023

First Posted

August 4, 2023

Study Start

April 26, 2024

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

April 25, 2024

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share