Effects of Analgesic Techniques on Duration of Spontaneously Laboring Patients

This study has been terminated.
(Low qualified candidate enrollment)
Sponsor:
Information provided by (Responsible Party):
Christopher Cambic, Northwestern University
ClinicalTrials.gov Identifier:
NCT01982838
First received: November 6, 2013
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Effects of; Anesthesia, in Labor and Delivery
Pregnancy
Prolonged First Stage of Labor
Procedure: Epidural de novo
Procedure: CSE

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of the Impact of Three Labor Analgesia Techniques on Labor Duration in Spontaneously Laboring Nulliparous Parturients

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Duration of first stage of labor [ Time Frame: Onset of contractions or spontaneous rupture of membrances to cervical dilation of 10cm ] [ Designated as safety issue: No ]
    Sterile cervical examinations at the first request for labor analgesia will be done, then at routine times during the course of labor per the managing OB provider's discretion. When the patient reaches 90-100% cervical effacement, cervical exams will be done every two hours thereafter until the patient reaches complete cervical dilation. Cervical examinations will be performed using a sterile glove, by each patient's labor and delivery nurse or physician.


Secondary Outcome Measures:
  • Presence or absence of fetal heart rate decelerations [ Time Frame: time of first analgesic dose - 60 minutes ] [ Designated as safety issue: No ]

Enrollment: 129
Study Start Date: July 2010
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group E
Epidural de novo technique
Procedure: Epidural de novo
Patients will have the epidural space identified with a loss-of-resistance technique utilizing a 17-G Tuohy epidural needle. 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.
Active Comparator: Group BF
Combined spinal epidural (CSE) technique with intrathecal 0.5% Bupivicaine 2.5mg + Fentanyl 15mcg
Procedure: CSE
The epidural space will be located using the loss-of-resistance technique utilizing a 17-G Tuohy epidural needle. Patients will receive the intrathecal study drug via a 27-G pencil-point spinal needle utilizing the standard needle-through-needle technique. A 19-G epidural catheter will be inserted 5 cm in the epidural space. Maintenance epidural analgesia will then be initiated.
Active Comparator: Group F
Combined spinal epidural (CSE) technique with intrathecal fentanyl 25mcg
Procedure: CSE
The epidural space will be located using the loss-of-resistance technique utilizing a 17-G Tuohy epidural needle. Patients will receive the intrathecal study drug via a 27-G pencil-point spinal needle utilizing the standard needle-through-needle technique. A 19-G epidural catheter will be inserted 5 cm in the epidural space. Maintenance epidural analgesia will then be initiated.

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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01982838

Locations
United States, Illinois
Northwestern Memoral Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Christopher Cambic, MD Northwestern University
  More Information

Publications:

Responsible Party: Christopher Cambic, Assistant Professor in Anesthesiology, Northwestern University
ClinicalTrials.gov Identifier: NCT01982838     History of Changes
Other Study ID Numbers: STU00031086
Study First Received: November 6, 2013
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
pain
epidural
combined spinal epidural

ClinicalTrials.gov processed this record on September 22, 2014