Effects of Analgesic Techniques on Duration of Spontaneously Laboring 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 Spontaneously Laboring Nulliparous Parturients
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 in spontaneous labor with whom analgesia is
maintained with a combined spinal epidural (CSE) technique versus nulliparous women in
spontaneous labor with whom an epidural de novo technique is utilized. 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 in spontaneous labor with whom analgesia is
maintained with a combined spinal epidural (CSE) technique versus nulliparous women in
spontaneous labor with whom an epidural de novo technique is utilized. 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.
Because 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 be assessed by a perinatologist. In addition to analyzing FHR
tracings for all included participants, the investigators also plan on analyzing plasma
epinephrine levels which will be drawn in each subgroup of patients.
Prior to placement of neuraxial technique, those patients included in this section of the
study will have a sample of venous blood drawn. A second sample of venous blood will be
redrawn 15 minutes and 30 minutes after the intrathecal dose or after initial epidural
bolus. All three samples will then be analyzed for plasma epinephrine concentrations. These
results will be compared with the FHR tracing analyses to see if there is any correlation.
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.
Because 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 be assessed by a perinatologist. In addition to analyzing FHR
tracings for all included participants, the investigators also plan on analyzing plasma
epinephrine levels which will be drawn in each subgroup of patients.
Prior to placement of neuraxial technique, those patients included in this section of the
study will have a sample of venous blood drawn. A second sample of venous blood will be
redrawn 15 minutes and 30 minutes after the intrathecal dose or after initial epidural
bolus. All three samples will then be analyzed for plasma epinephrine concentrations. These
results will be compared with the FHR tracing analyses to see if there is any correlation.
Inclusion Criteria:
- Nulliparous,
- American Society of Anesthesia Physical Status (ASA) 2 females
- >18 years-old
- term (>37 weeks gestation)
- singleton
- vertex pregnancies
- spontaneous labor or spontaneous rupture of membranes
Exclusion Criteria:
- Non-vertex presentation
- induction of labor
- contraindication to opioid or neuraxial analgesia
- contraindication to combine spinal-epidural technique (e.g. unfavorable airway exam)
- cervical dilation > 4.0 cm
- administration of systemic hydromorphone within 4 hours of epidural request
We found this trial at
1
site
Click here to add this to my saved trials
