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

Northwestern University

Status: Completed

Conditions: Labor Pain; Pregnancy

Treatments: Procedure: combined spinal epidural analgesia; Procedure: late analgesia (systemic)

Study type: Interventional

Funder types: Other

Identifiers

NCT00380978

0524-009

Details and patient eligibility

About

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.

Full description

Women in early labor frequently request pain medication. Obstetricians may prescribe narcotics (administered as an intravenous (IV) or intramuscular (IM) injection). However, IV or IM narcotics provide incomplete pain relief and have maternal and fetal/neonatal side effects, e.g., maternal drowsiness, respiratory depression, nausea, vomiting, and neonatal respiratory depression. Other obstetricians allow their patients to request early neuraxial (spinal or epidural) analgesia. The results of several studies comparing patients who received epidural versus IV/IM narcotic labor analgesia (not specifically in early labor)suggest that initiation of early neuraxial analgesia may be associated with higher Cesarean delivery rates. It has been hypothesized that epidural/spinal local anesthetics may induce pelvic musculature relaxation leading to failure of fetal descent and rotation. However, early pain may be a marker for other factors that increase the risk of Cesarean delivery, e.g., large or malpositioned baby, or dysfunctional labor. Whether or not early neuraxial analgesia (particularly if narcotic based, which would not cause pelvic muscle paralysis) compared to IV/IM narcotics, adversely affects the outcome of labor has not been studied in a randomized, prospective fashion. The purpose of this study is to compare Cesarean and forcep delivery rates, and quality of pain relief, in first-time mothers undergoing induction of labor who receive neuraxial versus IV/IM analgesia for early labor (cervical dilation < 4 cm).

Enrollment: 1,026 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,026 participants in 2 patient groups

early analgesia:combined-spinal epidural

Active Comparator group

Treatment:

Procedure: combined spinal epidural analgesia

late analgesia (systemic)

Active Comparator group

Treatment:

Procedure: late analgesia (systemic)