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

Study Overview
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Brief Summary
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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.

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

Conditions
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Analgesia, Obstetrical, Post-Dural Puncture Headache

Intervention / Treatment
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* Procedure: Resiting Epidural Catheter
* Procedure: Intrathecal Catheter Placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of UDP during labour Written informed consent Exclusion Criteria: Refusal to participate in the study History of PDPH

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Resiting Epidural Catheter<br> | Procedure: Resiting Epidural Catheter<br>* 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.<br>|
| Active Comparator: Intrathecal catheter placement<br> | Procedure: Intrathecal Catheter Placement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PDPH incidence | Incidence of post-dural puncture headache (PDPH) at 24 hours from UDP occurrence | At 24 hours from UDP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Chronic pain at 1 month | Incidence of chronic headache and chronic low back pain | At 1 month from UDP | 
| Chronic pain at 3 months | Incidence of chronic headache and chronic low back pain | 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) | 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) | Before discharge, an average of 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Labor Pain, Obstetric Labor Complications, Analgesia, Epidural