Clinical trial NCT03366935: Combined Implementation of Dural Puncture Epidural and Programmed Intermittent Epidural Bolus for Labor Analgesia
Official title: Combined Implementation of Dural Puncture Epidural Technique and Programmed Intermittent Epidural Bolus for Labor Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Labor Analgesia
Keywords: labor analgesia
dural puncture epidural (DPE)
standard Epidural (EPL)
continuous epidural infusion (CEI)
programmed intermittent epidural bolus (PIEB)
Lead sponsor: Shanghai First Maternity and Infant Hospital
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Compare time of onset of labor analgesia among the study groups
timeFrame: From epidural infusion initiate to delivery
Secondary outcomes:
measure: Incidence of side effect
timeFrame: 24 hours post delivery
measure: Sensory block level
timeFrame: 24 hours post delivery
measure: Total anesthetic dose required
timeFrame: From epidural infusion initiate to 1h post delivery
measure: Mode of delivery
timeFrame: From epidural infusion initiate to delivery
measure: Apgar scores
timeFrame: 30 mins post delivery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
Study officials:
affiliation: Department of Anesthesiaology, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
name: YuJie Song, MD
role: STUDY_CHAIR
References:
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citation: Song Y, Du W, Zhou S, Zhou Y, Yu Y, Xu Z, Liu Z. Effect of Dural Puncture Epidural Technique Combined With Programmed Intermittent Epidural Bolus on Labor Analgesia Onset and Maintenance: A Randomized Controlled Trial. Anesth Analg. 2021 Apr 1;132(4):971-978. doi: 10.1213/ANE.0000000000004768.