Clinical trial NCT01982851: Effects of Analgesic Techniques on Duration of Labor for Induction Patients
Official title: A Randomized Trial of the Impact of Three Labor Analgesia Techniques on Labor Duration in Nulliparous Labor Inductions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Effects of; Anesthesia, in Labor and Delivery
Pregnancy
Prolonged First Stage of Labor
Keywords: pain
epidural
combined spinal epidural
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if there is a difference in the duration of the first stage of labor in nulliparous women scheduled for an induction of labor, with whom analgesia is maintained with a combined spinal epidural (CSE) technique versus an epidural de novo technique. The investigators hypothesize that the duration of the first stage of labor will be no different in nulliparous patients who receive either intrathecal fentanyl or intrathecal fentanyl and bupivacaine, as part of a CSE technique. However, the duration of the first stage of labor will be shorter in parturients who receive intrathecal analgesia (as part of a CSE technique) compared to those who receive an epidural de novo technique with fentanyl and bupivacaine.

Detailed description: At the first request for neuraxial labor analgesia, the cervix will be examined. If \< 4.0 cm, the patient will be randomized to either Combined spinal epidural (CSE) technique with intrathecal fentanyl, CSE technique with intrathecal bupivacaine and fentanyl, or epidural de novo technique.

Labor analgesia will be administered in the sitting position, at either the L2-3 or L3-4 interspace. All patients will receive a 500mL intravenous bolus of Lactated Ringer's solution. The epidural space will be located using the loss-of-resistance technique utilizing a 17-G Tuohy epidural needle. Patients assigned to an intrathecal dose will utilize the standard needle-through-needle technique. A 19-G epidural catheter will be inserted 5 cm in the epidural space and maintenance epidural analgesia will be initiated. Patients assigned to an epidural de novo technique will have the epidural space identified with a similar loss-of-resistance technique. The epidural catheter will be inserted 5 cm into the epidural space. Epidural analgesia will be initiated with fentanyl 100mcg + bupivacaine 0.125% 10-20 mL (in divided doses). Maintenance epidural analgesia will then be initiated.

Maintenance epidural analgesia will consist of patient-controlled epidural analgesia (PCEA) with bupivacaine 0.0625% and fentanyl 1.95 mcg/mL at the following parameters: basal rate of 8 mL/hr with bolus dose = 8 mL, lock-out interval = 10 min and maximum volume = 32 mL/hr.

Breakthrough pain in all groups will be managed using anesthesiologist administered epidural boluses of bupivacaine 1.25 mg/mL, 10-15mL, without fentanyl. If instrumental vaginal delivery is required, patients will receive anesthesiologist administered epidural boluses of chloroprocaine 30 mg/mL, 5-10 mL. If a patient does not have an adequate level of analgesia or has a one-sided block, despite epidural redoses, the epidural catheter will be replaced at another level and 0.125% bupivacaine 5-15 mL will be administered until an adequate level of analgesia is established.

The primary outcome of the study is duration of first stage of labor. Regular cervical examinations are necessary. Typically, full cervical dilation is diagnosed with a cervical examination only when the patient complains of rectal pressure, which is likely to be at a later time period in women with effective neuraxial analgesia compared to women with systemic opioid analgesia. Therefore, the duration of the first stage of labor will be artificially prolonged if regular cervical exams are not performed. The investigators intend to perform sterile cervical examinations at the first request for labor analgesia, then at routine times during the course of labor per the managing OB provider's discretion, and then every 2 hours after the patient reaches 90-100% cervical effacement until complete cervical dilation.

Fetal heart rate (FHR) tracings without information about group assignment or other treatment modalities will also be assessed by a perinatologist.

Eligibility criteria: Inclusion Criteria:

* Nulliparous
* American Society of Anesthesia Physical Status (ASA) 2 females
* \> 18 years old
* term (\>37 weeks gestation)
* singleton
* vertex pregnancies
* scheduled induction of labor

Exclusion Criteria:

* Non-vertex presentation
* Spontaneous labor or spontaneous rupture of membranes
* contraindication to opioid or neuraxial analgesia
* contraindication to combine spinal-epidural technique (e.g. unfavorable airway exam)
* cervical dilation \> 4.0cm
* administration of systemic hydromorphine within 4 hours of epidural request

Primary outcomes:
measure: Duration of first stage of labor
timeFrame: Onset of contractions or rupture of membrances to cervical dilation of 10cm
Secondary outcomes:
measure: Presence or absence of fetal heart rate decelerations
timeFrame: Time of first analgesic dose to 60 minutes
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Christopher Cambic, MD
role: PRINCIPAL_INVESTIGATOR
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