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NCT Number: NCT03366935

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

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.

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Key information

Conditions

Labor Pain Labor Analgesia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Shanghai, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EPL and CEI

Other

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 CEI

Other

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 PIEB

Other

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).

Primary outcomes

  1. Compare time of onset of labor analgesia among the study groups

    Time frame: From epidural infusion initiate to delivery

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

Secondary outcomes

  1. Incidence of side effect

    Time frame: 24 hours post delivery

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

  2. Sensory block level

    Time frame: 24 hours post delivery

    Sensory block will be assessed bilaterally

  3. Total anesthetic dose required

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

    Including physician interventions, programmed doses, and patient controlled doses

  4. Mode of delivery

    Time frame: From epidural infusion initiate to delivery

    Spontaneous, Instrumental, or cesarean delivery

  5. Apgar scores

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Shanghai First Maternity and Infant Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 8, 2017
Registry last updated
Aug 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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