Effects of Analgesic Techniques on Duration of Labor for Induction Patients
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 5/3/2014 |
| Start Date: | July 2010 |
| End Date: | December 2015 |
| Contact: | Christopher Cambic, MD |
| Email: | c-cambic@northwestern.edu |
| Phone: | 312-472-3585 |
A Randomized Trial of the Impact of Three Labor Analgesia Techniques on Labor Duration in Nulliparous Labor Inductions
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.
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.
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.
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.
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
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