Labor Analgesia, Labor Pain
Conditions
Keywords
labor analgesia, dural puncture epidural (DPE), standard Epidural (EPL), continuous epidural infusion (CEI), programmed intermittent epidural bolus (PIEB)
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.
Interventions
OTHEREPL and CEI
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).
OTHERDPE and CEI
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).
OTHERDPE and PIEB
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).
Sponsors
Shanghai First Maternity and Infant Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Total anesthetic dose required | From epidural infusion initiate to 1h post delivery | Including physician interventions, programmed doses, and patient controlled doses |
| 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 |
Countries
China
Outcome results
None listed