Combined Implementation of Dural Puncture Epidural and Programmed Intermittent Epidural Bolus for Labor Analgesia

Study Overview
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Brief Summary
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This study intends to carry out a prospective, randomized double-blind study to evaluate the safety and efficacy of the combined implementation of Dural puncture epidural (DPE) technique and Programmed intermittent epidural bolus (PIEB) for labor analgesia.

Detailed Description
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Epidural (EPL) technique is the standard technique for labor analgesia, but can be associated with slow onset and inadequate sacral spread, unilateral or patchy sensory blockade, motor impairment. The combined spinal epidural (CSE) technique can provide rapid onset of analgesia, but is associated with greater side effects, including pruritus, fetal bradycardia and delayed testing of epidural catheters. Dural puncture epidural (DPE) technique is a modification of CSE technique. A spinal needle is introduced through the epidural needle to create a single dural puncture , after intrathecal space was identified by the free flow of cerebrospinal fluid (CSF) , the needle was removed without direct medication administration into the subarachnoid space. Privous studies have demonstrated that the DPE technique can improve block quality over the EPL technique with fewer maternal and fetal side effects than the CSE technique for parturients requesting labor analgesia. Besides the neuraxial techniques, maintenance regimens is another factor that affect the analgesic effect. Programmed intermittent epidural bolus (PIEB) provides greater spread of local anesthetic solution within the epidural space and therefore superior quality of analgesia compared with continuous epidural infusion (CEI). We designed this prospective randomized, double-blind study to evaluate the safety and efficacy of the combined implementation of DPE technique and PIEB for labor analgesia.

Official Title
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Combined Implementation of Dural Puncture Epidural Technique and Programmed Intermittent Epidural Bolus for Labor Analgesia

Conditions
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Labor Pain, Labor Analgesia

Intervention / Treatment
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* Other: EPL and CEI
* Other: DPE and CEI
* Other: DPE and PIEB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women requeste labor analgesia ASA I or II at 37-42 weeks' gestation nulliparous singleton pregnancy, vertex presentation visual Numerical Rating Scale (VNRS) at requesting analgesia > 5 (NRPS 0-10) cervical dilatation < 5 cm Exclusion Criteria: patient refusal to participate in the study age <20 years or >40 years body mass Index(BMI)>50 (Kg/m2) clinically significant diseases of pregnancy (i.e.,gestational hypertension, preeclampsia, gestational placenta previa, placental abruption diabetes) contraindications to neuraxial analgesia drug abuse conditions associated with an increased risk of a cesarean delivery (i.e., history of uterine anomaly or surgery, morbid obesity) and known anomalies

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EPL and CEI<br>Those with receive a standard epidural (EPL) and continuous epidural infusion(CEI) + patient-controlled epidural analgesia (PCEA) | Other: EPL and CEI<br>* Procedure: Standard epidural placement(EPL) Drug: ropivacaine Drug: sufentani 0.1% ropivacaine + sufentanil 0.3μg/mL Device: Infusion pump Infusion pump set to continuous epidural infusion(CEI) plus patient-controlled epidural analgesia (PCEA).<br>|
| Active Comparator: DPE and CEI<br>Those with receive a dural puncture labor epidural (DPE) and continuous epidural infusion(CEI) + patient-controlled epidural analgesia (PCEA) | Other: DPE and CEI<br>* Procedure: Dural puncture epidural (DPE) Epidural with spinal needle placed to create a single dural puncture and confirm free flow of cerebral spinal fluid (CSF) , without direct medication administration into the subarachnoid space. Drug: ropivacaine Drug: sufentani 0.1% ropivacaine + sufentanil 0.3μg/mL Device: Infusion pump Infusion pump set to continuous epidural infusion(CEI) plus patient-controlled epidural analgesia (PCEA).<br>|
| Active Comparator: DPE and PIEB<br>Those with receive a dural puncture labor epidural (DPE) and programmed intermittent epidural boluses(PIEB) + patient-controlled epidural analgesia (PCEA) | Other: DPE and PIEB<br>* Procedure: Dural puncture epidural (DPE) Epidural with spinal needle placed to create a single dural puncture and confirm free flow of cerebral spinal fluid (CSF) , without direct medication administration into the subarachnoid space. Drug: ropivacaine Drug: sufentani 0.1% ropivacaine + sufentanil 0.3μg/mL Device: Infusion pump Infusion pump set to programmed intermittent epidural boluses (PIEB) plus patient-controlled epidural analgesia (PCEA).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare time of onset of labor analgesia among the study groups | Visual Numerical Rating Scale (VNRS) ≤ 10 mm on a 100-mm scale | From epidural infusion initiate to delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of side effect | maternal hypotension,fetal bradycardia, maternal motor block,post-dural puncture headache,nausea, vomiting,pruritus,nerve damage | 24 hours post delivery | 
| Sensory block level | Sensory block will be assessed bilaterally | 24 hours post delivery | 
| Total anesthetic dose required | Including physician interventions, programmed doses, and patient controlled doses | From epidural infusion initiate to 1h post delivery | 
| Mode of delivery | Spontaneous, Instrumental, or cesarean delivery | From epidural infusion initiate to delivery | 
| Apgar scores | The Apgar scale is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are skin color, pulse rate, reflex irritability grimace, activity and respiratoty effort | 30 mins post delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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labor analgesia, dural puncture epidural (DPE), standard Epidural (EPL), continuous epidural infusion (CEI), programmed intermittent epidural bolus (PIEB)