Analgesia, ObstetricalItaREVINCT05977361
Intrathecal Catheter Placement Versus Resiting Epidural Catheter After Dural Puncture in Obstetric Patients
A study testing Resiting Epidural Catheter and Intrathecal Catheter Placement in people with Analgesia, Obstetrical and Post-Dural Puncture Headache, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Analgesia, Obstetrical, Post-Dural Puncture Headache
- What is being tested?
- Resiting Epidural Catheter and Intrathecal Catheter Placement
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- No sites listed yet
- Study dates
- 26 Apr 2024to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of UDP during labour
- Written informed consent
Who cannot join
- Refusal to participate in the study
- History of PDPH
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Being tested
- Resiting Epidural Catheter, Intrathecal Catheter Placement
- Keywords
- Labor Pain, Obstetric Labor Complications, Analgesia, Epidural
- Medical subject headings
- Agnosia, Post-Dural Puncture Headache, Labor Pain, Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resiting Epidural CatheterProcedure or surgery
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 PlacementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Resiting Epidural Catheter | Active comparator | Not described Receives: Procedure: Resiting Epidural Catheter |
| Intrathecal catheter placement | Active comparator | Not described Receives: Procedure: Intrathecal Catheter Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
PDPH incidence
Incidence of post-dural puncture headache (PDPH) at 24 hours from UDP occurrence
Measured: At 24 hours from UDP
Secondary outcomes (8)
PDPH intensity at 24 hours
PDPH intensity, rated using a 10-point scale, ranging from 0 ("no pain") to 10 ("worst pain imaginable")
Measured: 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")
Measured: 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.
Measured: 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.
Measured: 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
Measured: At 1 month from UDP
Chronic pain at 3 months
Incidence of chronic headache and chronic low back pain
Measured: 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)
Measured: 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)
Measured: Before discharge, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start26 Apr 2024 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia, ObstetricalStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 181 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977361
- Sponsor's protocol ID
- ItaREVI
- Acronym
- ItaREVI
- Status last verified
- Jul 2023
- First submitted
- 20 Jul 2023
- Last updated
- 25 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Catheter Placement Versus Resiting Epidural Catheter After Dural Puncture in Obstetric Patients: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05977361
- Acronym / sponsor ID
- ItaREVI / ItaREVI
- Keywords
- Labor Pain, Obstetric Labor Complications, Analgesia, Epidural
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 181 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 26 Apr 2024 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resiting Epidural Catheter | Active comparator | Procedure: Resiting Epidural Catheter |
| Intrathecal catheter placement | Active comparator | Procedure: Intrathecal Catheter Placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed diagnosis of UDP during labour
- Written informed consent
Key exclusion criteria (2 listed)
- Refusal to participate in the study
- History of PDPH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resiting Epidural CatheterAfter 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. | Procedure or surgery | Resiting Epidural Catheter |
| Intrathecal Catheter PlacementAfter 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. | Procedure or surgery | Intrathecal catheter placement |
Primary outcome
PDPH incidence
Time frame: At 24 hours from UDP
Incidence of post-dural puncture headache (PDPH) at 24 hours from UDP occurrence
8 secondary outcomes
PDPH intensity at 24 hours
Time frame: At 24 hours from UDP
PDPH intensity at 48 hours
Time frame: At 48 hours from UDP
Quality of analgesia
Time frame: During the entire course of labour, an average of 12 hours
Adverse events
Time frame: During the entire follow-up period, up to 3 months from UDP
Chronic pain at 1 month
Time frame: At 1 month from UDP
Chronic pain at 3 months
Time frame: At 3 months from UDP
Readmission to hospital
Time frame: Up to 3 months from UDP
Patient's satisfaction
Time frame: Before discharge, an average of 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Resiting Epidural Catheter and Intrathecal Catheter Placement in people with Analgesia, Obstetrical and Post-Dural Puncture Headache, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruno A Zanfini, MD, PhD (06 3015 3105, brunoantonio.zanfini@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PDPH incidence (time frame: At 24 hours from UDP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.