Analgesic Efficacy of a Multiport Versus Uniport Flexible Catheter for Labor Epidural Analgesia

Study Overview
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Brief Summary
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The purpose of this study is to determine whether multiple ports improve the analgesic efficacy of flexible catheters used for the provision of epidural analgesia during the entire continuum of labor and delivery

Detailed Description
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Multiport catheters, when compared to uniport catheters, have been associated with better analgesic quality during labor epidural analgesia because the presence of more than one port may enhance the distribution of epidural medication Flexible catheters, when compared to rigid catheters, have been associated with better analgesic quality during labor epidural analgesia because greater flexibility may minimize catheter deviation in the epidural space, facilitate more optimal catheter placement in the epidural space, and result in better distribution of epidural medication It is unknown whether multiple ports, which promote better distribution of epidural medication, provide added analgesic benefit to flexible catheters, which also facilitate better distribution of epidural medication, when used for the provision of epidural analgesia during labor and delivery

Official Title
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Prospective, Controlled, Randomized, Blinded, Single-center Study of the Clinical Efficacy and Outcomes of a Multiport Versus Uniport Flexible Catheter for Epidural Analgesia During Labor and Delivery

Conditions
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Labor Pain

Intervention / Treatment
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* Device: Multiport flexible catheter
* Device: Uniport flexible catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists Classification I-III parturients Mixed parity Estimated gestational age of at least 37 weeks Singleton gestation Cephalic presentation Spontaneous or induced labor Exclusion Criteria: Body mass index (BMI) > 45 kg/m2 Prior cesarean section Multiple gestation Fetal abnormality Use of chronic analgesic medication Local anesthetic allergy Coagulopathy or anticoagulation Infection at epidural insertion site Spinal deformity other than mild scoliosis Uncontrolled/uncompensated/uncorrected cerebral, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, endocrinologic, metabolic, or hematologic condition

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Multiport flexible catheter<br>Multiport flexible catheter has three ports for the delivery of epidural medication for labor analgesia | Device: Multiport flexible catheter<br>* Multiport flexible catheter has three ports for the delivery of epidural medication<br>|
| Active Comparator: Uniport flexible catheter<br>Uniport flexible catheter has one port for the delivery of epidural medication for labor analgesia | Device: Uniport flexible catheter<br>* Uniport flexible catheter has one port for the delivery of epidural medication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic success rate | Incidence of adequate analgesia at initiation of labor epidural analgesia | 30 minutes following the initiation of labor epidural analgesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inadequate analgesia at initiation of labor epidural analgesia |  | 30 minutes following the initiation of labor epidural analgesia | 
| Catheter replacement at initiation of labor epidural analgesia |  | 45 minutes following the initiation of labor epidural analgesia | 
| Adequate analgesia during the first stage of labor | Determined from patients receiving patient controlled epidural analgesia (PCEA) who do not require clinician interventions | The duration of first stage of labor, an expected average of 6 hours and 30 minutes | 
| Patient controlled epidural analgesia (PCEA) demands during the first stage of labor |  | The duration of first stage of labor, an expected average of 6 hours and 30 minutes | 
| Clinician interventions during the first stage of labor |  | The duration of first stage of labor, an expected average of 6 hours and 30 minutes | 
| Visual analogue scale (VAS) pain score at the time of clinician interventions during the first stage of labor |  | The duration of first stage of labor, an expected average of 6 hours and 30 minutes | 
| Catheter replacement during the first stage of labor |  | The duration of first stage of labor, an expected average of 6 hours and 30 minutes | 
| Adequate analgesia during the second stage of labor |  | The duration of second stage of labor, an expected average of 1 hour and 30 minutes | 
| Inadequate analgesia during the second stage of labor |  | The duration of second stage of labor, an expected average of 1 hour and 30 minutes | 
| Inadequate analgesia that failed epidural supplementation during the second stage of labor |  | The duration of second stage of labor, an expected average of 1 hour and 30 minutes | 
| Anesthetic success rate | Incidence of adequate anesthesia at initiation of epidural anesthesia for cesarean delivery | 10 minutes following the initiation of epidural anesthesia for cesarean delivery | 
| Inadequate anesthesia at initiation of epidural anesthesia for cesarean delivery |  | 10 minutes following the initiation of epidural anesthesia for cesarean delivery | 
| Supplementation for breakthrough pain during maintenance of epidural anesthesia for cesarean delivery |  | The duration of cesarean delivery, an expected average of 50 minutes | 
| Difficult catheter insertion |  | The duration of epidural catheter placement, an expected average of 15 minutes | 
| Paresthesias |  | The duration of epidural catheter placement, an expected average of 15 minutes | 
| Intravascular cannulation |  | The duration of epidural catheter placement, an expected average of 15 minutes | 
| Intrathecal placement |  | The duration of epidural catheter placement, an expected average of 15 minutes | 
| Difficult catheter removal |  | The duration of epidural catheter removal, an expected average of 5 minutes | 
| Catheter breakage |  | The duration of epidural catheter removal, an expected average of 5 minutes | 
| Catheter wire uncoiling |  | The duration of epidural catheter removal, an expected average of 5 minutes | 
| Maternal satisfaction with the overall quality of analgesia/anesthesia during labor and delivery |  | 24 hours following delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural catheter, Epidural analgesia, Labor epidural analgesia, Analgesic efficacy, Multiport epidural catheter, Uniport epidural catheter, Flexible epidural catheter