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Effects of Analgesic Techniques on Duration of Labor for Induction Patients

This study has been terminated.
(low qualified candidate enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01982851
First Posted: November 13, 2013
Last Update Posted: March 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Christopher Cambic, Northwestern University
  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 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.

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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of the Impact of Three Labor Analgesia Techniques on Labor Duration in Nulliparous Labor Inductions

Further study details as provided by Christopher Cambic, Northwestern University:

Primary Outcome Measures:
  • Duration of first stage of labor [ Time Frame: Onset of contractions or rupture of membrances to cervical dilation of 10cm ]
    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 to 60 minutes ]

Enrollment: 134
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01982851


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

Publications:
Halpern S, Leighton B: Epidural analgesia and the progress of labor, Evidence-based obstetric anesthesia. Edited by Halpern S, Douglas M. Oxford, Blackwell, 2005, pp10-22

Responsible Party: Christopher Cambic, Assistant Professor of Anesthesiology, Northwestern University
ClinicalTrials.gov Identifier: NCT01982851     History of Changes
Other Study ID Numbers: STU00031120
First Submitted: November 6, 2013
First Posted: November 13, 2013
Last Update Posted: March 11, 2014
Last Verified: March 2014

Keywords provided by Christopher Cambic, Northwestern University:
pain
epidural
combined spinal epidural

Additional relevant MeSH terms:
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics