The clinical trial of programed intermittent epidural bolus Interval 90 (EI90)
The research company Menoufia University is conducting the clinical trial Effectiveness of Programed Intermittent Epidural Bolus Interval 90 (EI90) of 10 ml, 0.0625% Bupivacaine Plus 2 μg/mL Fentanyl interval90(EI90)of10ml,0.0625%Bupivacaine Plus 2μg/mL Fentanyl.
Multiple studies showed the numerous advantages of implementing programmed epidural bolus (PIEB) technique, where a fixed volume of local anesthetic is automatically administrated at a set time interval compared to the continuous epidural infusion technique (CEI). The advantages were improved maternal satisfaction, decreased local anesthetic consumption, and decreased second stage of labor.The theory behind PIEB is that to attain a more uniform spread of local anesthetic in the epidural space a higher volume of injectate and a higher pressure is needed.Different approaches using different timings and volumes for PIEB have been proposed to achieve the optimal regimen. Many studies showed evidence that 10 mL boluses of bupivacaine 0.0625% with fentanyl 2 μg/mL delivered every 40 min, named effective programed intermittent epidural bolus interval 90 (EI90), produced effective analgesia without breakthrough pain in 90% of nulliparous women during the first stage of labor.
It is planned to include 30 participants.
Actual study start date is May 31, 2022. The researchers expect to complete the study by November 2022.
One primary outcome measure is adequate labour analgesia, Time of first call for bolus dose of epidural After loading dose.
The location of the study is as follows: https://ichgcp.net/clinical-trials-registry/NCT05441085 or https://clinicaltrials.gov/ct2/show/NCT05441085.
