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

Shanghai First Maternity and Infant Hospital120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Labor Pain Labor Analgesia

Interventions

EPL and CEIOTHER

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).

DPE and CEIOTHER

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).

DPE and PIEBOTHER

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).

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. women requeste labor analgesia 2. ASA I or II 3. at 37-42 weeks' gestation 4. nulliparous 5. singleton pregnancy, vertex presentation 6. visual Numerical Rating Scale (VNRS) at requesting analgesia \> 5 (NRPS 0-10) 7. cervical dilatation \< 5 cm Exclusion Criteria: 1. patient refusal to participate in the study 2. age \<20 years or \>40 years 3. body mass Index(BMI)\>50 (Kg/m2) 4. clinically significant diseases of pregnancy (i.e.,gestational hypertension, preeclampsia, gestational placenta previa, placental abruption diabetes) 5. contraindications to neuraxial analgesia 6. drug abuse 7. conditions associated with an increased risk of a cesarean delivery (i.e., history of uterine anomaly or surgery, morbid obesity) and known anomalies

Locations (1)

Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine

Shanghai, China

Outcomes

Primary Outcomes

Compare time of onset of labor analgesia among the study groups

Visual Numerical Rating Scale (VNRS) ≤ 10 mm on a 100-mm scale

Time frame: From epidural infusion initiate to delivery

Secondary Outcomes

Incidence of side effect

maternal hypotension,fetal bradycardia, maternal motor block,post-dural puncture headache,nausea, vomiting,pruritus,nerve damage

Time frame: 24 hours post delivery

Sensory block level

Sensory block will be assessed bilaterally

Time frame: 24 hours post delivery

Total anesthetic dose required

Including physician interventions, programmed doses, and patient controlled doses

Time frame: From epidural infusion initiate to 1h post delivery

Mode of delivery

Spontaneous, Instrumental, or cesarean delivery

Time frame: 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

Time frame: 30 mins post delivery

Data from ClinicalTrials.gov

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