piperidines and Breech-Presentation

Our objective was to compare the effect of two pain relief methods (remifentanil vs. nitrous oxide) on the success rate of external cephalic version.. We conducted a randomized open label parallel-group controlled single-center clinical trial with sequential design, at Cruces University Hospital, Spain. Singleton pregnancies in noncephalic presentation at term that were referred for external cephalic version were assigned according to a balanced (1:1) restricted randomization scheme to analgesic treatment with remifentanil or nitrous oxide during the procedure. The primary endpoint was external cephalic version success rate. Secondary endpoints were adverse event rate, degree of pain, cesarean rate and perinatal outcomes.. The trial was stopped early after the second interim analysis due to a very low likelihood of finding substantial differences in efficacy (futility). The external cephalic version success rate was the same in the two arms (31/60, 51.7%) with 120 women recruited, 60 in each arm. The mean pain score was significantly lower in the remifentanil group (3.2 ± 2.4 vs. 6.0 ± 2.3; p < 0.01). No differences were found in external cephalic version-related complications. There was a trend toward a higher frequency of adverse effects in the remifentanil group (18.3% vs. 6.7%, p = 0.10), with a significantly higher incidence rate (21.7 events/100 women vs. 6.7 events/100 women with nitrous oxide, p = 0.03). All reported adverse events were mild and reversible.. Remifentanil for analgesia decreased external cephalic version-related pain but did not increase the success rate of external cephalic version at term and appeared to be associated with an increased frequency of mild adverse effects.

Topics: Adult; Analgesics; Breech Presentation; Cesarean Section; Early Termination of Clinical Trials; Female; Humans; Labor Pain; Labor, Obstetric; Nitrous Oxide; Pain Management; Pain Measurement; Piperidines; Pregnancy; Pregnancy Outcome; Remifentanil; Treatment Outcome

Although external cephalic version (ECV) can be effective for correcting the fetus in a cephalic presentation, it may be painful for the mother. This study aimed to evaluate the efficacy and safety of remifentanil for pain relief during ECV in China.. In all, 152 Chinese parturients with singleton breech presentation were randomly divided into 2 groups, each with 76 patients. All 152 patients were assigned to receive either remifentanil (infused at 0.1 μg/kg/min and demand boluses of 0.1 μg/kg) or saline placebo. The study was performed between January 2012 and December 2015. Outcome measurements included the Numerical Rating Pain Scale score (0-10) after ECV, success rate for ECV, and maternal satisfaction after ECV. Adverse events were also evaluated.. The study was completed by 146 patients. Remifentanil showed greater efficacy than placebo in decreasing the pain score immediately after ECV (remifentanil 4.6 ± 2.6 vs placebo 6.5 ± 2.7; P < 0.001). The success rate for ECV showed a significant difference between the 2 groups (remifentanil 56.5% vs placebo 39.5%; P = 0.04). Maternal satisfaction also showed a significant difference between the 2 groups (remifentanil 9.6 ± 1.4 vs placebo 6.4 ± 3.7; P < 0.001). However, the adverse events profiles were similar between both groups.. The results of this study demonstrate that remifentanil is an effective intervention for reducing pain, achieving successful ECV, and increasing maternal satisfaction during ECV, and is generally well-tolerated without additional adverse effects.

Topics: Adult; Analgesics, Opioid; Anesthesia, Obstetrical; Breech Presentation; Female; Humans; Infant, Newborn; Pain Measurement; Piperidines; Pregnancy; Remifentanil; Treatment Outcome; Version, Fetal

Successful external cephalic version (ECV) for breech presenting fetus reduces the need for Caesarean section (CS). We aimed to compare the success rate of ECV with either spinal anaesthesia (SA) or i.v. analgesia using remifentanil.. In a double-phased, stratified randomized blinded controlled study we compared the success rates of ECV, performed under spinal anaesthesia (SA), i.v. analgesia (IVA) using remifentanil or no anaesthetic interventions. In phase I, 189 patients were stratified by parity before randomization to ECV, performed by blinded operators, under SA using either hyperbaric bupivacaine 9 mg with fentanyl 15 µg, i.v. remifentanil infusion 0.1 µg kg min(-1), or Control (no anaesthetic intervention). Operators performing ECV were blinded to the treatment allocation. In phase 2, patients in the Control group in whom the initial ECV failed were further randomized to receive either SA (n=9) or IVA (n=9) for a re-attempt. The primary outcome was the incidence of successful ECV.. The success rate in Phase 1 was greatest using SA [52/63 (83%)], compared with IVA [40/63 (64%)] and Control [40/63 (64%)], (P=0.027). Median [IQR] pain scores on a visual analogue scale (range 0-100), were 0 [0-0] with SA, 35 [0-60] with IVA and 50 [30-75] in the Control group (P<0.001). Median [IQR] VAS sedation scores were highest with IVA [75 (50-80)], followed by SA, [0 (0-50)] and Control [0 (0-0)]. In phase 2, 7/9 (78%) of ECV re-attempts were successful with SA, whereas all re-attempts using IVA failed (P=0.0007). The incidence of fetal bradycardia necessitating emergency CS within 30 min, was similar among groups; 1.6% (1/63) in the SA and IVA groups and 3.2% (2/63) in the Control group.. SA increased the success rate and reduced pain for both primary and re-attempts of ECV, whereas IVA using remifentanil infusion only reduced the pain. There was no significant increase in the incidence of fetal bradycardia or emergency CS, with ECV performed under anaesthetic interventions. Relaxation of the abdominal muscles from SA appears to underlie the improved outcomes for ECV.

Topics: Adult; Anesthesia, Obstetrical; Anesthesia, Spinal; Anesthetics, Intravenous; Anesthetics, Local; Bradycardia; Breech Presentation; Bupivacaine; Cesarean Section; Female; Fentanyl; Heart Rate, Fetal; Humans; Infant, Newborn; Pain Measurement; Piperidines; Pregnancy; Remifentanil; Version, Fetal

Breech presentation occurs in up to 3% of pregnancies at term and may be an indication for caesarean delivery. External cephalic version can be effective in repositioning the fetus in a cephalic presentation, but may be painful for the mother. Our aim was to assess the efficacy of remifentanil versus placebo for pain relief during external cephalic version.. A randomized, double-blind, controlled trial that included women at 36-41 weeks of gestation with non-cephalic presentations was performed. Women were randomized to receive either a remifentanil infusion at 0.1 μg/kg/min and demand boluses of 0.1 μg/kg, or saline placebo. The primary outcome was the numerical rating pain score (0-10) after external cephalic version.. Sixty women were recruited, 29 in the control group and 31 in the remifentanil group. There were significant differences in pain scores at the end of the procedure (control 6.5 ± 2.4 vs. remifentanil 4.7 ± 2.5, P = 0.005) but not 10 min later (P = 0.054). The overall success rate for external cephalic version was 49% with no significant differences between groups (remifentanil group 54.8% vs. control group 41.3%, P = 0.358). In the remifentanil group, there was one case of nausea and vomiting, one of drowsiness and three cases of fetal bradycardia. In the control group, there were three cases of nausea and vomiting, one of dizziness and nine cases of fetal bradycardia.. Intravenous remifentanil with bolus doses on demand during external cephalic version achieved a reduction in pain and increased maternal satisfaction. There were no additional adverse effects, and no difference in the success rate of external cephalic version or the incidence of fetal bradycardia.

Topics: Adult; Analgesia; Analgesics, Opioid; Bradycardia; Breech Presentation; Dizziness; Double-Blind Method; Female; Fetal Diseases; Humans; Nausea; Pain; Pain Management; Patient Satisfaction; Piperidines; Placebos; Pregnancy; Remifentanil; Treatment Outcome; Version, Fetal; Vomiting

To compare the forces exerted during external cephalic version (ECV) on the maternal abdomen between ( 1 ) the primary attempts performed without spinal analgesia (SA), which failed and ( 2 ) the subsequent reattempts performed under SA.. Patients with an uncomplicated singleton breech-presenting pregnancy suitable for ECV were recruited. During ECV, the operator wore a pair of gloves, which had thin piezo-resistive pressure sensors measuring the contact pressure between the operator's hands and maternal abdomen. For patients who had failed ECV, reattempts by the same operator was made with patients under SA, and the applied force was measured in the same manner. The profile of the exerted forces over time during each attempt was analyzed and denoted by pressure-time integral (PTI: mmHg sec). Pain score was also graded by patients using visual analogue scale. Both PTI and pain score before and after the use of SA were then compared.. Overall, eight patients who had a failed ECV without SA underwent a reattempt with SA. All of them had successful version and the median PTI of the successful attempts under SA were lower than that of the previous failed attempts performed without SA (127 386 mmHg sec vs. 298,424 mmHg sec; p = 0.017). All of them also reported a 0 pain score, which was significantly lower than that of before (median 7.5; p = 0.016).. SA improves the success rate of ECV as well as reduces the force required for successful version.

Topics: Analgesia, Epidural; Analgesics; Anesthesia, Intravenous; Anesthesia, Spinal; Breech Presentation; Bupivacaine; Female; Fentanyl; Humans; Pain Management; Piperidines; Pregnancy; Pressure; Recurrence; Remifentanil; Treatment Failure; Treatment Outcome; Version, Fetal