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

NACompletedINTERVENTIONAL
Enrollment

1,026

Participants

Timeline

Start Date

October 31, 2001

Primary Completion Date

September 30, 2008

Study Completion Date

September 30, 2008

Conditions
Labor PainPregnancy
Interventions
PROCEDURE

combined spinal epidural analgesia

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.

PROCEDURE

late analgesia (systemic)

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.

Trial Locations (1)

60611

Northwestern Memorial Hospital, Chicago

All Listed Sponsors
collaborator

International Anesthesia Research Society (IARS)

OTHER

lead

Northwestern University

OTHER

NCT00380978 - Neuraxial Versus Systemic Analgesia for Latent Phase Labor Effect on Rate of Operative Delivery | Biotech Hunter | Biotech Hunter