Determination of the ED95 of intrathecal hyperbaric prilocaine with sufentanil for scheduled cesarean delivery: a dose-finding study based on the continual reassessment method

P Goffard, Y Vercruysse, R Leloup, J-F Fils, S Chevret, Y Kapessidou, P Goffard, Y Vercruysse, R Leloup, J-F Fils, S Chevret, Y Kapessidou

Abstract

Background: Scheduled cesarean section is routinely performed under spinal anesthesia using hyperbaric bupivacaine. The current study was undertaken to determine the clinically relevant 95% effective dose of intrathecal 2% hyperbaric prilocaine co-administered with sufentanil for scheduled cesarean section, using continual reassessment method.

Methods: We conducted a dose-response, prospective, double-blinded study to determine the ED95 values of intrathecal hyperbaric prilocaine used with 2,5 mcg of sufentanil and 100 mcg of morphine for cesarean delivery. Each parturient enrolled in the study received an intrathecal dose of hyperbaric prilocaine determined by the CRM and the success or failure of the block was assessed as being the primary endpoint.

Results: The doses given for each cohort varied from 35 to 50 mg of HP, according to the CRM, with a final ED95 lying between 45 and 50 mg of Prilocaine after completion of the 10 cohorts. Few side effects were reported and patients were globally satisfied.

Conclusions: The ED95 of intrathecal hyperbaric prilocaine with sufentanil 2.5 μg and morphine 100 μg for elective cesarean delivery was found to be between 45 and 50 mg. It may be an interesting alternative to other long-lasting local anesthetics in this context.

Trial registration: The study was registered on January 30, 2017 - retrospectively registered - and results posted at the public database clinicaltrials.gov ( NCT03036384 ).

Keywords: Cesarean section; Continual reassessment method; ED95; Hyperbaric prilocaine; Sufentanil.

Conflict of interest statement

GP was invited by Sintetica SA as a speaker for a lecture at the Euroanaesthesia 2019 congress in Vienna, Austria, entitled “Hyperbaric prilocaine for intermediate and short duration procedures”. Expenses relating to speaking engagements were refunded by the society.

Figures

Fig. 1
Fig. 1
Continual Reassessment Method
Fig. 2
Fig. 2
Sequence of doses
Fig. 3
Fig. 3
Probability of success and 95% credibilty intervals
Fig. 4
Fig. 4
Estimated response probability and 95% credibility interval for the proposed ED95
Fig. 5
Fig. 5
Evolution of sensitive block
Fig. 6
Fig. 6
Evolution of motor block

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Source: PubMed

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