drugset / Trial / NCT06494280

PIEB Compared With CEI on Breakthrough Pain in Nulliparous Women

NCT06494280 ↗

Recruiting 240 enrolled Holy Family Hospital, Nazareth, Israel
RandomizedParallel-groupSingle-blindOther

Summary

The goal of this randomized controlled trial is to examine the impact of programmed intermittent bolus epidural analgesia technique on the incidence of breakthrough pain during labor in nulliparous women compared to continuous epidural infusion. Nulliparous women will randomly be divided during labor into two groups; study group will receive mix of Bupivacaine and fentanyl once (bolus) every 60 minutes; the control group will receive continuously the same dose during an hour, until delivery.

Timeline

Start
2024-09-10
Primary completion
2026-11
Completion
2026-12

Publications

  • Results 1. American College of Obstetricians and Gynecologists. Obstetric analgesia and anesthesia. ACOG Practice Bulletin No. 209. Obstet Gynecol. 2019;133:e208-25. 2. Anim-Somuah M, Smyth RM, Cyna AM, Cuthbert A. Epidural versus non-epidural or no analgesia for pain management in labour. Cochrane Database of Systematic Reviews 2018:5;CD000331. 3. Jones L, Othman M, Dowswell T, Alfirevic Z, Gates S, Newburn M, et al. Pain management for women in labour: an overview of systematic reviews. Cochrane Database of Systematic Reviews 2012:3;CD009234. 4. George RB, Allen TK, Habib AS. Intermittent epidural bolus compared with continuous epidural infusions for labor analgesia: a systematic review and meta-analysis. Anesth Analg 2013;116:133-44. 5. Sng BL, Zeng Y, de Souza NNA, Leong WL, Oh TT, Siddiqui FJ, Assam PN, Han NR, Chan ES, Sia AT. Automated mandatory bolus versus basal infusion for maintenance of epidural analgesia in labour. Cochrane Database Syst Rev. 2018;5:CD011344. 6. Ferrer LE, Romero DJ, Vasquez OI, Matute EC, Van de Velde M. Effect of programmed intermittent epidural boluses and continuous epidural infusion on labor analgesia and obstetric outcomes: a randomized controlled trial. Arch Gynecol Obstet. 2017;296:915-22. 7. Ojo OA, Mehdiratta JE, Gamez BH, Hunting J, Habib AS. Comparison of programmed intermittent epidural boluses with continuous epidural infusion for the maintenance of labor analgesia: a randomized, controlled, double-blind study. Anesth Analg. 2020;130:426-35. 8. Haidl F, Arne Rosseland L, Rorvik AM, Dahl V. Programmed intermittent boluses vs continuous epidural infusion in labor using an adrenaline containing solution: A randomized trial. Acta Anaesthesiol Scand. 2020;64:1505-12. 9. Riazanova OV, Alexandrovich YS, Guseva YV, Ioscovich AM. A randomized comparison of low dose ropivacaine programmed intermittent epidural bolus with continuous epidural infusion for labour analgesia. Rom J Anaesth Intensive Care. 2019;26:25-30. 10. Fan Y, Hou W, Feng S, Mao P, Wang X, Jiang J, Yuan H, Shen X, Feng S, Li P. Programmed intermittent epidural bolus decreases the incidence of intra-partum fever for labor analgesia in primiparous women: a randomized controlled study. Arch Gynecol Obstet. 2019;300:1551-7 11. Xu J, Zhou J, Xiao H, Pan S, Liu J, Shang Y, Yao S. A systematic review and meta-analysis comparing programmed intermittent bolus and continuous infusion as the background infusion for parturient-controlled epidural analgesia. Sci Rep. 2019;9:2583. 12. Wang XX, Zhang XL, Zhang ZX, Xin ZQ, Guo HJ, Liu HY, Xiao J, Zhang YL, Yuan SZ. Programmed intermittent epidural bolus in parturients: a meta-analysis of randomized controlled trials. Medicine (Baltimore). 2022;101: e28742. 13. Bullingham A, Liang S, Edmonds E, Mathur S, Sharma S. Continuous epidural infusion vs programmed intermittent epidural bolus for labour analgesia: a prospective, controlled, before-and-after cohort study of labour outcomes. Br J Anaesth. 2018;121:432-7. 14. Lin Y, Li Q, Liu J, Yang R, Liu J. Comparison of continuous epidural infusion and programmed intermittent epidural bolus in labor analgesia. Ther Clin Risk Manag. 2016;12:1107-12. 15. Lim Y, Sia AT, Ocampo C. Automated regular boluses for epidural analgesia: a comparison with continuous infusion. Int J Obstet Anesth. 2005;14:305-9. 16. Salim R, Nachum Z, Moscovici R, Lavee M, Shalev E. Continuous compared with intermittent epidural infusion on progress of labor and patient satisfaction. Obstet Gynecol 2005;106:301-6. 17. Lim Y, Ocampo CE, Supandji M, Teoh WH, Sia AT. A randomized controlled trial of three patient-controlled epidural analgesia regimens for labor. Anesth Analg 2008;107:1968-72. 18. Capogna G, Camorcia M, Stirparo S, Farcomeni A. Programmed intermittent epidural bolus versus continuous epidural infusion for labor analgesia: the effects on maternal motor function and labor outcome. A randomized double-blind study in nulliparous women. Anesth Analg 2011;113:826-31. 19. Carvalho B, George RB, Cobb B, McKenzie C, Riley ET. Implementation of Programmed Intermittent Epidural Bolus for the Maintenance of Labor Analgesia. Anesth Analg 2016;123:965-71 20. Diez-Picazo LD, Guasch E, Brogly N, Gilsanz F. Is breakthrough pain better managed by adding programmed intermittent epidural bolus to a background infusion during labor epidural analgesia? A randomized controlled trial. Minerva Anestesiol. 2019;85:1097-104. 21. Roofthooft E, Barbé A, Schildermans J, Cromheecke S, Devroe S, Fieuws S, Rex S, Wong CA, Van de Velde M. Programmed intermittent epidural bolus vs. patient-controlled epidural analgesia for maintenance of labour analgesia: a two-centre, double-blind, randomised study. Anaesthesia. 2020;75:1635-42. 22. Sultan P, Murphy C, Halpern S, Carvalho B. The effect of low concentrations versus high concentrations of local anesthetics for labour analgesia on obstetric and anesthetic outcomes: a meta-analysis. Can J Anaesth. 2013;60:840-54.

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 0.1 % Other
Comparator Fentanyl Other / unclassified 2 ug/ml Other

Indications

No indication recorded.