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

Not Applicable

Completed

• Conditions: Labor Pain; Labor Analgesia
• Interventions: Other: DPE and CEI; Other: EPL and CEI; Other: DPE and PIEB

• Registration Number: NCT03366935
• Lead Sponsor: Shanghai First Maternity and Infant Hospital

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.

Study Timeline

• Study Start: 2017-10-10
• Study First Submitted: 2017-12-04
• Study First Submitted QC: 2017-12-04
• Study First Posted: 2017-12-08
• Primary Completion: 2018-06-08
• Study Completion: 2018-06-30
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-30
• Last Update Posted: 2018-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DPE and CEI	DPE and CEI	Those with receive a dural puncture labor epidural (DPE) and continuous epidural infusion(CEI) + patient-controlled epidural analgesia (PCEA)
EPL and CEI	EPL and CEI	Those with receive a standard epidural (EPL) and continuous epidural infusion(CEI) + patient-controlled epidural analgesia (PCEA)
DPE and PIEB	DPE and PIEB	Those with receive a dural puncture labor epidural (DPE) and programmed intermittent epidural boluses(PIEB) + patient-controlled epidural analgesia (PCEA)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Total anesthetic dose required	From epidural infusion initiate to 1h post delivery	Including physician interventions, programmed doses, and patient controlled doses
Incidence of side effect	24 hours post delivery	maternal hypotension,fetal bradycardia, maternal motor block,post-dural puncture headache,nausea, vomiting,pruritus,nerve damage
Sensory block level	24 hours post delivery	Sensory block will be assessed bilaterally
Mode of delivery	From epidural infusion initiate to delivery	Spontaneous, Instrumental, or cesarean delivery
Apgar scores	30 mins post delivery	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

Trial Locations

Locations (1)

Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine; 🇨🇳 Shanghai, China