Margaret G Craig1, Erica N Grant, Weike Tao, Donald D McIntire, Kenneth J Leveno. 1. From the Department of Anesthesiology and Pain Management (M.G.C., E.N.G., W.T.) and Department of Obstetrics and Gynecology (D.D.M., K.J.L.), The University of Texas Southwestern Medical Center, Dallas, Texas.
Abstract
BACKGROUND: The purpose of this prospective, double-blinded, parallel-arm, randomized trial was to examine the effects of epidural bupivacaine on the length of the second stage of labor in nulliparous women. METHODS: The authors assessed length of second-stage labor, degree of motor blockade, mode of delivery, and visual analog scores in 310 nulliparous women with labor epidurals randomized to receive either: (1) 0.125% bupivacaine and fentanyl 2 μg/ml or (2) fentanyl 10 μg/ml alone via epidural using double blinding. RESULTS: The median duration of the second stage was 75 min (41, 128) in the bupivacaine/fentanyl group versus 73 min (42, 120) in the fentanyl-only group (P = 0.17) with a median difference of 6.0 (95% CI, -6.0 to 18.0). Furthermore, there was no difference in degree of motor blockade, incidence of operative delivery, visual analog scores, or neonatal outcomes between the two groups. No adverse events were reported. CONCLUSIONS: Use of epidural bupivacaine/fentanyl or a fentanyl-only infusion during the second stage of labor did not affect the duration of the second stage of labor, degree of motor blockade, mode of delivery, pain relief, and maternal or neonatal outcomes. However, in the fentanyl-only infusion group, there was a fivefold increase in opioid exposure to the fetus with unknown effects on neurobehavior, an outcome not assessed beyond the immediate postnatal period in this study.
RCT Entities:
BACKGROUND: The purpose of this prospective, double-blinded, parallel-arm, randomized trial was to examine the effects of epidural bupivacaine on the length of the second stage of labor in nulliparous women. METHODS: The authors assessed length of second-stage labor, degree of motor blockade, mode of delivery, and visual analog scores in 310 nulliparous women with labor epidurals randomized to receive either: (1) 0.125% bupivacaine and fentanyl 2 μg/ml or (2) fentanyl 10 μg/ml alone via epidural using double blinding. RESULTS: The median duration of the second stage was 75 min (41, 128) in the bupivacaine/fentanyl group versus 73 min (42, 120) in the fentanyl-only group (P = 0.17) with a median difference of 6.0 (95% CI, -6.0 to 18.0). Furthermore, there was no difference in degree of motor blockade, incidence of operative delivery, visual analog scores, or neonatal outcomes between the two groups. No adverse events were reported. CONCLUSIONS: Use of epidural bupivacaine/fentanyl or a fentanyl-only infusion during the second stage of labor did not affect the duration of the second stage of labor, degree of motor blockade, mode of delivery, pain relief, and maternal or neonatal outcomes. However, in the fentanyl-only infusion group, there was a fivefold increase in opioid exposure to the fetus with unknown effects on neurobehavior, an outcome not assessed beyond the immediate postnatal period in this study.
Authors: Semra Ozdemir; Teresa Chen; Chin Wen Tan; Wei Han Melvin Wong; Hon Sen Tan; Eric Andrew Finkelstein; Ban Leong Sng Journal: Patient Prefer Adherence Date: 2022-04-08 Impact factor: 2.711