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A biased coin up-and-down sequential allocation trial to determine the optimum programmed intermittent epidural bolus time interval between 5 mL boluses of bupivacaine 0.125% with fentanyl 2 µg·mL−1

  • Ricardo BittencourtEmail author
  • Cristian Arzola
  • Paul Zakus
  • Kristi Downey
  • Xiang Y. Ye
  • Jose Carlos Almeida Carvalho
Reports of Original Investigations
  • 81 Downloads

Abstract

Purpose

The optimal epidural mixtures and settings for programmed intermittent epidural bolus (PIEB) labour analgesia have yet to be determined. A previous study by our group demonstrated that 10 mL boluses of bupivacaine 0.0625% with fentanyl 2 µg·mL−1 administered every 40 min provided effective analgesia during the first stage of labour for 90% of women, without breakthrough pain. We wanted to determine the effective PIEB time interval of 5 mL boluses of bupivacaine 0.125% with fentanyl 2 µg·mL−1 under the same study circumstances, aiming at a future comparative study.

Methods

This double-blind dose-finding study used the biased coin up-and-down sequential allocation method to determine the effective PIEB interval 90% (EI90) needed to provide effective analgesia without breakthrough pain during the first stage of labour. We used fixed 5 mL boluses of bupivacaine 0.125% with fentanyl 2 µg.mL−1 and studied time intervals of 60, 50, 40, and 30 min. The first patient was assigned an interval of 60 min and the remaining intervals were assigned as per the biased coin up-and-down method.

Results

The estimated EI90 was 36.5 min (95% confidence interval [CI], 34.0 to 39.0) by the truncated Dixon and Mood method and 34.2 min (95% CI, 30.8 to 41.5) by the isotonic regression method. We found that 20/40 women had an upper sensory block to ice above T6, 34/40 women had no motor block, and no woman required treatment for hypotension.

Conclusion

The EI90 between 5 mL boluses of bupivacaine 0.125% with fentanyl 2 µg·mL−1 during the first stage of labour is approximately 35 min.

Trial registration

www.clinicaltrials.gov (NCT #02758405); registered 2 May, 2016.

Une étude d’attribution séquentielle par intervalles croissants et décroissants avec tirage biaisé afin de déterminer l’intervalle de temps optimal entre des bolus périduraux de 5 mL de bupivacaïne 0,125 % avec 2 µg·mL−1 de fentanyl

Résumé

Objectif

Les formulations médicamenteuses péridurales et les paramètres optimaux pour une analgésie du travail obstétrical en mode PIEB (bolus péridural intermittent programmé) n’ont pas encore été déterminés. Dans une étude précédente, nous avons démontré que des bolus de 10 mL de bupivacaïne 0,0625 % avec 2 µg·mL−1 de fentanyl, administrés toutes les 40 min, procuraient à 90 % des femmes une analgésie efficace et sans incidence de percées de douleur paroxystique pendant le premier stade du travail. Dans cette étude, nous avons souhaité déterminer l’intervalle efficace entre les bolus de 5 mL de bupivacaïne 0,125 % avec 2 µg·mL−1 de fentanyl administrés en mode PIEB en respectant les mêmes conditions d’étude, ayant à l’esprit la réalisation d’une future étude comparative.

Méthode

Cette étude de détermination de dose en double insu s’est appuyée sur une méthode d’attribution séquentielle par intervalles croissants et décroissants avec tirage biaisé afin de déterminer l’intervalle de PIEB efficace à 90 % (IE90) nécessaire pour procurer une analgésie efficace sans incidence de percées de douleur paroxystique pendant le premier stade du travail obstétrical. Nous avons utilisé des bolus fixes de 5 mL de bupivacaïne 0,125 % avec 2 µg·mL−1 de fentanyl et étudié des intervalles de 60, 50, 40 et 30 min. Un intervalle de 60 min a été attribué à la première patiente et les intervalles subséquents ont été attribués selon une méthode de tirage biaisé par suites croissantes et décroissantes.

Résultats

L’IE90 estimé était de 36,5 min (intervalle de confiance [IC] 95 %, 34,0 à 39,0) selon la méthode Dixon et Mood tronquée et 34,2 min (IC 95 %, 30,8 à 41,5) selon la méthode de régression isotonique. Selon nos observations, 20/40 femmes ont présenté un bloc sensoriel à la glace supérieur à T6, 34/40 femmes n’ont eu aucun bloc moteur, et aucune femme n’a dû être traitée pour de l’hypotension.

Conclusion

L’IE90 entre les bolus de 5 mL de bupivacaïne 0,125 % avec 2 µg·mL−1 de fentanyl pendant le premier stade de travail obstétrical est d’environ 35 min.

Enregistrement de l’étude

www.clinicaltrials.gov (NCT #02758405); enregistrée le 2 mai 2016.

Notes

Competing interests

None declared.

Editorial responsibility

This submission was handled by Dr. Gregory L. Bryson, Deputy Editor-in-Chief, Canadian Journal of Anesthesia.

Author contributions

Ricardo Bittencourt, Cristian Arzola, Paul Zakus, Kristi Downey, and Jose Carvalho contributed to all aspects of this manuscript, including study conception and design; acquisition, analysis, and interpretation of data and drafting the article. Xiang Y. Ye contributed to study conception and design, analysis and interpretation of data and drafting the article.

Funding

None.

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Copyright information

© Canadian Anesthesiologists' Society 2019

Authors and Affiliations

  1. 1.Department of Anesthesia and Pain Management, Mount Sinai HospitalUniversity of TorontoTorontoCanada
  2. 2.Department of Pediatrics, Micare Research Centre, Mount Sinai HospitalUniversity of TorontoTorontoCanada
  3. 3.Department of Anesthesia and Pain Management, Mount Sinai HospitalUniversity of TorontoTorontoCanada

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