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Comparison of Chloroprocaine to Lidocaine/ Epinephrine/ Bicarbonate/ Fentanyl for Epidural Anesthesia in Elective Cesarean Delivery: A Randomized study
Abstract Number: T2D-315
Abstract Type: Original Research
Background: Epidural extension anesthesia allows rapid conversion of labor epidural analgesia into surgical anesthesia. The ideal local anesthetic solution for epidural extension anesthesia remains unclear, with most evidence drawn from observational data.
Methods: This single center randomized, double-blind, noninferiority study conducted from February to November 2018 tested the hypothesis that chloroprocaine (CP) would be noninferior to a mixture of lidocaine, epinephrine, bicarbonate, and fentanyl (LEBF) in terms of onset time to surgical readiness for epidural extension anesthesia. ASA II patients with a singleton pregnancy scheduled for elective cesarean delivery (CD) had lumbar epidurals placed pre-operatively. Analgesia was induced with 0.0625% bupivacaine with 2 mcg/ml fentanyl to achieve a T10 sensory level. The same solution was infused at 10 ml/hr until OR entry. Participants with bilateral blockade were randomized into 2 groups: group CP received 20 ml of 3% CP with 4 ml saline and group LEBF received 20 ml of 2% lidocaine, 0.15 ml of 0.1% epinephrine, 2 ml of 8.4% bicarbonate, 100 mcg fentanyl. Dosing was standardized to measure time to loss of touch sensation bilaterally at the T7 dermatomal level, the primary outcome. The secondary outcome was the need for intraoperative analgesia supplementation. The non-inferiority margin was set at 180 sec, and the study was powered assuming a standard deviation of 4 minutes, to a significance level of 5% and a power of 90%.
Results: 70 patients (35 in each group) were enrolled; 2 patients from CP and 1 from LEBF were withdrawn due to inadequate block preoperatively. Demographics, side effects and duration of surgery were comparable between groups. Analysis of the primary outcome to surgical onset time between the CP group (655 + 258 sec) and LEBF group (558 + 269 sec) of - 97 sec (95% CI, - 11 to 204; P=0.003). The upper CI of the difference 204 sec, was more than the predefined noninferiority margin of 180 sec (Figure 1). Therefore, the data is insufficient to confirm noninferiority of CP compared to LEBF. 7 CP patients (21%) and 4 LEBF patients (12%) required intraoperative analgesia supplementation (P=0.3).
Discussion: CP was found to be not non-inferior to LEBF in regards to onset times of surgical anesthesia for CD. Future investigations should evaluate whether LEBF provides faster onset of anesthesia compared with CP.