A randomized controlled comparison of epidural analgesia and combined spinal-epidural analgesia in a private practice setting: pain scores during first and second stages of labor and at delivery.

BACKGROUND: There has been no prospective evaluation of combined spinal-epidural (CSE) analgesia in a private practice setting and few studies have focused on pain relief during the second stage of labor and at delivery. In this randomized controlled trial, we compared verbal pain scores during the first and second stages of labor and at delivery in women receiving CSE or traditional epidural analgesia at a busy private maternity hospital. METHODS: Healthy, term parturients received epidural or CSE analgesia for labor pain upon request. Epidural analgesia was initiated with 0.125% bupivacaine plus 2 µg/mL fentanyl, 15 mL; CSE analgesia was initiated with intrathecal plain bupivacaine 3.125 mg plus 5 µg fentanyl. Thereafter, patient-controlled epidural analgesia with 0.125% bupivacaine plus 2 µg/mL fentanyl was used for maintenance analgesia in both groups. The primary outcome was an assessment of "typical" pain, using a verbal rating pain score from 0 to 10, made at the end of the first stage of labor and shortly after delivery. RESULTS: Data from 398 epidural and 402 CSE subjects were analyzed. The typical verbal rating pain score during the first stage was lower in the CSE group (mean: 1.4 vs 1.9; P < 0.001; 99.5% confidence interval [CI] for difference: -0.92, -0.14). Pain scores during the second stage of labor (1.7 vs 1.9; P = 0.17; 99.5% CI for difference: -0.82, 0.28) and at delivery (2.0 vs 2.0; P = 0.77; 99.5% CI for difference: -0.73, 0.59) were the same between groups. Fewer patients received an epidural top-up dose in the CSE group (16.4% vs 25.6%; P = 0.002; 99.5% CI for difference: -17.0%, -1.0%). Epidural catheters were replaced in 1.2% CSE vs 2% in the epidural group (P = 0.39; 99.5% CI for difference: -3.3%, 1.8%). CONCLUSIONS: Compared with traditional epidural labor analgesia, CSE analgesia provided better first-stage analgesia despite fewer epidural top-up injections by an anesthesiologist.

The safety and efficacy of a fentanyl patient-controlled transdermal system for acute postoperative analgesia: a multicenter, placebo-controlled trial.

UNLABELLED: A noninvasive method of delivery of parenteral opioids for management of acute pain may offer logistic advantages for patients and nursing staff. A patient-controlled transdermal system (PCTS) under development consists of a preprogrammed, self-contained drug-delivery system that uses electrotransport technology (E-TRANS, ALZA Corp, Mountain View, CA) to deliver 40 micro g of fentanyl HCl over 10 min per on-demand dose for patient-controlled analgesia (PCA). In this randomized, double-blinded, placebo-controlled trial we compared the efficacy and safety of on-demand fentanyl HCl PCTS 40 microg against placebo for postoperative pain up to 24 h after major abdominal, orthopedic, or thoracic surgery in 205 patients. The primary efficacy measurement was the percentage of patients withdrawn from the study because of inadequate analgesia after completing at least 3 h of treatment. Secondary efficacy measures included mean pain intensity (using visual analog scales), patient global assessments, and investigator global assessments. Of 189 patients considered evaluable for efficacy, 25% of patients in the fentanyl HCl PCTS 40 microg group withdrew because of inadequate analgesia, compared with 40.4% of the placebo group (P < 0.05). Use of fentanyl HCl PCTS 40 micro g was associated with lower VAS scores and higher mean patient and investigator global assessment scores compared with placebo. No patient experienced clinically relevant respiratory depression. This study showed that a fentanyl HCl PCTS 40 microg for PCA was superior to placebo and well tolerated for the control of moderate to severe postoperative pain for up to 24 h after major surgery. IMPLICATIONS: This multicenter, randomized, double-blinded, placebo-controlled trial showed that an on-demand fentanyl HCl patient-controlled transdermal system (PCTS) was superior to placebo and well tolerated for the control of moderate to severe postoperative pain for up to 24 h after major surgery. This fentanyl HCl PCTS is a preprogrammed, needle free, self-contained drug-delivery system that uses electrotransport technology (iontophoresis) to deliver 40 microg of fentanyl per on-demand dose.