BACKGROUND AND OBJECTIVES:Intrathecal fentanyl provides effective labor analgesia for a limited time with frequent side effects. We evaluated the effects of adding epinephrine to intrathecal fentanyl with and without bupivacaine. METHODS:Eighty healthy, term, nulliparous parturients with cervical dilation of 5 cm or less receivedcombined spinal-epidural (CSE) analgesia. Subjects were randomized in a double-blind fashion to 1 of 4 intrathecal solutions containing fentanyl 35 microg with either saline (F); bupivacaine 2.5 mg + saline (FB); bupivacaine 2.5 mg + epinephrine 100 microg (FBE); or epinephrine 100 microg + saline (FE). Patients were evaluated for visual analog pain score, duration of spinal analgesia (time until patient request for additional analgesia), nausea/vomiting, pruritus, sensory and motor block, maternal blood pressure, and fetal heart rate (FHR). RESULTS:Intrathecal bupivacaine significantly prolonged fentanyl analgesia with or without epinephrine (P =.018), but epinephrine did not significantly prolong the duration of fentanyl alone or with bupivacaine (F, 92 +/- 39 minutes; FB, 125 +/- 31 minutes; FBE, 134 +/- 42 minutes; and FE, 117 +/- 48 minutes). Intrathecal epinephrine was associated with a higher incidence of severe nausea (P =.001), and the FBE group had more lower extremity weakness (P =.047). There was no difference in the incidence of severe pruritus, FHR deceleration, or delivery outcome between the groups. CONCLUSIONS: These results suggest that intrathecal epinephrine does not prolong the duration of fentanyl or fentanyl with bupivacaine for labor analgesia in nulliparous parturients. Additionally, intrathecal epinephrine did not decrease the incidence of side effects and therefore cannot be recommended.
RCT Entities:
BACKGROUND AND OBJECTIVES: Intrathecal fentanyl provides effective labor analgesia for a limited time with frequent side effects. We evaluated the effects of adding epinephrine to intrathecal fentanyl with and without bupivacaine. METHODS: Eighty healthy, term, nulliparous parturients with cervical dilation of 5 cm or less received combined spinal-epidural (CSE) analgesia. Subjects were randomized in a double-blind fashion to 1 of 4 intrathecal solutions containing fentanyl 35 microg with either saline (F); bupivacaine 2.5 mg + saline (FB); bupivacaine 2.5 mg + epinephrine 100 microg (FBE); or epinephrine 100 microg + saline (FE). Patients were evaluated for visual analog pain score, duration of spinal analgesia (time until patient request for additional analgesia), nausea/vomiting, pruritus, sensory and motor block, maternal blood pressure, and fetal heart rate (FHR). RESULTS: Intrathecal bupivacaine significantly prolonged fentanyl analgesia with or without epinephrine (P =.018), but epinephrine did not significantly prolong the duration of fentanyl alone or with bupivacaine (F, 92 +/- 39 minutes; FB, 125 +/- 31 minutes; FBE, 134 +/- 42 minutes; and FE, 117 +/- 48 minutes). Intrathecal epinephrine was associated with a higher incidence of severe nausea (P =.001), and the FBE group had more lower extremity weakness (P =.047). There was no difference in the incidence of severe pruritus, FHR deceleration, or delivery outcome between the groups. CONCLUSIONS: These results suggest that intrathecal epinephrine does not prolong the duration of fentanyl or fentanyl with bupivacaine for labor analgesia in nulliparous parturients. Additionally, intrathecal epinephrine did not decrease the incidence of side effects and therefore cannot be recommended.
Authors: Eugene R Viscusi; James P Rathmell; Alessandro Fichera; Sander R Binderow; Robert J Israel; Frank L Galasso; Darryl Penenberg; Tong J Gan Journal: J Drug Assess Date: 2013-08-27