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

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05977361
• Collaborator: (none)
• Enrollment: 181
• Arms: 2
• Anticipated Duration (Months): 27

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Analgesia, Obstetrical; Post-Dural Puncture Headache	Procedure: Resiting Epidural Catheter; Procedure: Intrathecal Catheter Placement	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 181 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Intrathecal Catheter Placement Versus Resiting Epidural Catheter After Dural Puncture in Obstetric Patients: a Multicenter Randomized Controlled Trial
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Nov 1, 2025
• Anticipated Study Completion Date: Jan 1, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. PDPH incidence [At 24 hours from UDP]

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

Secondary Outcome Measures

1. 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")

2. 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")

3. 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.

4. 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.

5. Chronic pain at 1 month [At 1 month from UDP]

   Incidence of chronic headache and chronic low back pain

6. Chronic pain at 3 months [At 3 months from UDP]

   Incidence of chronic headache and chronic low back pain

7. 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)

8. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Confirmed diagnosis of UDP during labour

• Written informed consent

Exclusion Criteria:

• Refusal to participate in the study

• History of PDPH

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• ClinicalTrials.gov Identifier: NCT05977361
• Other Study ID Numbers: ItaREVI
• First Posted: Aug 4, 2023
• Last Update Posted: Aug 4, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fondazione Policlinico Universitario Agostino Gemelli IRCCS: Labor Pain; Obstetric Labor Complications; Analgesia, Epidural
• Additional relevant MeSH terms: Post-Dural Puncture Headache; Headache

Study Results

No Results Posted as of Aug 4, 2023