A Comparison Between 2 Methods of Local Anesthetic Administration for Maintaining Labor Analgesia After Dural Puncture Epidural

Study Overview
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Brief Summary
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Intermittent epidural bolus technique opens a new era of interest for maintaining labor anlagesia. The study examines programmed intermittent epidural bolus technique on a scheduled basis to provider-administered bolus anlgesia on patient request, after a dural puncture epidural technique.

Detailed Description
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After dural puncture, an epidural catheter will be placed on nulliparous women between 38 and 40 weeks of gestation presenting for labor . All will receive an test dose of 3ml lidocaine 2%, for properly checking the catheter placement and then an initial dose of 10ml ropivacaine 0,2% with 2 mcg/ml fentanyl. After that, women will be randomly assigned on two groups. Both groups will be receiving the same dose of analgesia (10ml ropivacaine 0,2% plus 1,5 mcg/ml fentanyl. However, one group will be receiving them on scheduled time intervals as programmed intermittent boluses every 60minutes and the other only on patient request for pain relief. Pain scores, satisfaction, time for adequate analgesia, bromage scores,apgar scores, fetal arterial blood gases, time for delivery and type of delivery will be studied

Official Title
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A Comparison Between 2 Methods of Local Anesthetic Administration for Maintaining Labor Analgesia After Dural Puncture Epidural

Conditions
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Labor Pain, Epidural, Pain, Labor

Intervention / Treatment
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* Procedure: Programmed intermittent bolus epidural
* Procedure: Provider administered analgesia on patient request


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -nulliparous women 38th week of gestation Exclusion Criteria: patient refusal to have an epidural patient refusal to participate contraindication for epidural ASA>3 neurologic deficit/impairment allergy on local anesthetic chronic pain syndromes

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Programmed intermittent Bolus Epidural technique<br>10ml ropivacaine 0,2% and 1,5 mcg/ml fentanyl, will be administered every 60 minutes via an epidural catheter placed for labor analgesia on L2-L3/L3-L4 level | Procedure: Programmed intermittent bolus epidural<br>* one arm will receive programmed intermittent boluses of local anesthetic via the epidural catheter on fixed time intervals. Standard 27G Tuohy needle epidural set with epidural catheter insertion on L2-L3 site, with the patient either sitting or in the lateral decubitus position will be used. Local injection with 6 ml lidocaine 2% will be performed before the insertion of the epidural needle<br>|
| Active Comparator: Provider administered bolus epidural technique on patient request<br>10ml ropivacaine 0,2% and 1,5 mcg/ml fentanyl, will be administered by the provider on patient request | Procedure: Provider administered analgesia on patient request<br>* one arm will receive bolus of local anesthetic via the catheter upon patient request. Standard 27G Tuohy needle epidural set with epidural catheter insertion on L2-L3 site, with the patient either sitting or in the lateral decubitus position will be used. Local injection with 6 ml lidocaine 2% will be performed before the insertion of the epidural needle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total local anesthetic and opioid administration | the total mg of local anesthetic and opioid consumed via the epidural catheter until the neonate delivery | 24hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time needed for delivery | how long will it take for the baby to be delivered(in minutes) | 24hours | 
| total patient satisfaction | from a scale of 0 to 10, higher score signifies better outcome | 24hours | 
| apgar score | a test given to newborns soon after birth. This test checks a baby's heart rate, muscle tone, and other signs to see if extra medical care or emergency care is needed. The test is usually given twice: once at 1 minute after birth, and again at 5 minutes after birth.The higher the score the better the baby's condition willl be (the scale is from 0 to 10) | 24hours | 
| Bromage score | This scale assesses the intensity of motor block by the patient's ability to move their lower extremities. O signifies free movement and 4 complete paralysis(higher score means worse outcome) | 24hours | 
| type of delivery | whether it will be vaginal delivery, vaginal assisted delivery with instruments or a cesarean section | 24hours | 
| neonatal arterial blood gases | when the baby will be delivered, a neonatal arterial blood gas will be measured | 24hours | 
| time for sucessful level of analgesia | the time needed after epidural bolus to reach a scale below 3 on the NRS scale for pain assesment | 24hours | 
| Pain score(NRS scale) | n a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 . O represents no pain and 10 the worst pain ever possible | 24hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dural puncture, programmed intermittent bolus, labor analgesia