Neuraxial Versus Systemic Analgesia for Latent Phase Labor Effect on Rate of Operative Delivery

NCT00380978 | Completed Results

• 1 other identifier: 0524-009
• Study Type: interventional
• Target: 1,026
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study in nulliparous women undergoing induction of labor is to determine whether initiation of neuraxial analgesia compared to systemic opioid analgesia early in labor (\< 4 cm cervical dilation)affects the cesarean delivery rate.

Conditions

Labor Pain; Pregnancy

Keywords

labor pain; cesarean section; epidural analgesia; opioid analgesics; local anesthetics; labor induced

Outcome Measures

Primary Outcomes (1)

• Delivered by Cesarean Section

  The decision to proceed to operative delivery was made by the obstetric team for maternal or fetal indications.

  Time form initiation of labor analgesia to delivery (up to 24 hours)

Secondary Outcomes (7)

• Instrumented Vaginal Delivery

  At time of decision for delivery

• Duration of Labor

  Initiation of induction of labor to time of delivery

• Indication for Cesarean Delivery

  At time of decision for delivery

• Analgesia Efficacy

  At first and second analgesia requests

• Nausea

  At second analgesia request

Study Arms (2)

early analgesia:combined-spinal epidural

ACTIVE COMPARATOR

Procedure: combined spinal epidural analgesia

late analgesia (systemic)

ACTIVE COMPARATOR

Procedure: late analgesia (systemic)

Interventions

combined spinal epidural analgesia PROCEDURE

Analgesia was initiated in the early group using a standard needle-through-needle technique with intrathecal fentanyl 25 mcg and an epidural test dose of lidocaine 15 mg/ml and epinephrine 5 mcg/ml in 3ml. At the second analgesia request, the cervix was examined. Epidural analgesia was initiated with a dilute bupivicaine/fentanyl solution if the cervix was less than 4 cm. If the cervix was 4 cm or more, epidural analgesia was initiated with bupivicaine 1.25 mg/ml. If no cervical exam was performed at the second request for analgesia, the cervix was assumed to be at least 4 cm dilated. Thereafter, analgesia was maintained in all participants in the early group with patient-controlled epidural analgesia.

Also known as: CSE

early analgesia:combined-spinal epidural

late analgesia (systemic) PROCEDURE

Analgesia was initiated in the late group with hydromorphone 1mg intramuscularly (IM) and 1 mg intravenously (IV). If the cervix was less than 4 cm at the second analgesia request, hydromorphone analgesia was repeated. Epidural analgesia was initiated with bupivicaine 1.25 mg/ml if the cervix was 4 cm or more. At the third analgesia request, epidural analgesia was initiated regardless of cervical dilation. Thereafter, epidural analgesia was maintained with patient controlled analgesia until delivery.

Also known as: Dilaudid, narcotic

late analgesia (systemic)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• induction of labor
• nulliparity
• \>36 weeks gestation
• singleton
• vertex position
• cervical dilation \< 4 cm at first request for analgesia
• desires neuraxial analgesia

You may not qualify if:

• spontaneously laboring
• multiparity
• nonvertex presentation
• at or \>4cm at analgesia request
• chronic opioid therapy
• acute opioid therapy within 4 hours of analgesia request
• allergy to study drugs (hydromorphone, fentanyl, bupivacaine, lidocaine)

Sponsors & Collaborators

• Northwestern University: lead
• International Anesthesia Research Society (IARS): collaborator

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Wong CA, Scavone BM, Peaceman AM, McCarthy RJ, Sullivan JT, Diaz NT, Yaghmour E, Marcus RJ, Sherwani SS, Sproviero MT, Yilmaz M, Patel R, Robles C, Grouper S. The risk of cesarean delivery with neuraxial analgesia given early versus late in labor. N Engl J Med. 2005 Feb 17;352(7):655-65. doi: 10.1056/NEJMoa042573.

  PMID: 15716559 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Interventions

Hydromorphone; Narcotics

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Limitations and Caveats

The study was not powered to detect a small difference between groups in the cesarean delivery rate. It was not blinded. Different obstetric providers have different management styles, and different triggers for performing cesarean delivery.

Results Point of Contact

• Title: Dr. Robert J. McCarthy
• Organization: Department of Anesthesiology; Northwestern University Feinberg School of Medicine

r-mccarthy@northwestern.edu

312-926-9015

Study Officials

• Cynthia A Wong, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: September 25, 2006
• First Posted: September 27, 2006
• Study Start: October 1, 2001
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: April 14, 2014
• Results First Posted: December 8, 2011

Record last verified: 2014-03

Locations

US (1)