Comparing of programmed intermittent epidural bolus (PIEB) with continuous epidural infusion (CEI) for labor analgesia in patients receiving epidural dexmedetomidine and Rupivacaine

Comparing of programmed intermittent epidural bolus with continuous epidural infusion in labor analgesia with solution of Dexmedetomidine and Rupivacaine

Clinical trial, with parallel groups, double-blind, randomized, phase 2-3 on 60 patients. In order to randomize, the block randomization method will be used.

In Akbarabadi Hospital, women with a gestational age greater than or equal to 37 weeks will be enrolled to the study. Patients will be randomly divided into 2 groups based on Blocks with size 6. The sample size for each study group is 30. A total of 60 patients will be examined. Patientsو surgeons and data analyzer will be blind.

Inclusion criteria: Term women with gestational age 37 weeks or more, Cervical dilation Larger than 4 cm, Spontaneous or induced labor pain, Applying for epidural analgesia, Weight 55 to 85 kg. Exclusion criteria: History of sever cardiovascular diseases, Contraindication of epidural analgesia, Patients that are candidate for cesarean section ( multiple pregnancy , gestational age more than 37 weeks, preeclampsia , etc ), Patient discontent, Opium addiction, Height less than 150 cm

In the first intervention group: with programmed intermittent epidural bolus, bolus dose of 8cc of the solution will be administered every 60 minutes regularly. In the second intervention group: with continuous epidural infusion, infusion of 8 cc/hr of the solution consumption as maintenance after loading dose will be administered continuously by an infusion pomp.

Degree of reduced labor pain and pain relief maternal satisfaction; Total analgesic solution consumption; Apgar score; Side effects and hemodynamic changes

Patients will be randomly assigned to tree groups by using a random number table. In order to randomize, a random block method will be used. For this purpose, we formed blocks of size 6. In each block, 3 individuals will be in first intervention group and 3 will be in second intervention group. A total of 10 blocks will be considered for the study.

Surgeons and patients will be kept blind and unaware of the type of labor analgesia . Patients will be aware that they will be randomly assigned to one of two treatment groups, but will be unaware of which analgesic method will be provided in that group. Patients will be assigned to one of two groups using random number tables. The surgeon also knows that patients will be anesthetized in two different ways, but will not know which procedure will be performed for each patient. The data collection officer, analyst and outcome assessor will collect and analyze information based on groups 1 and 2 and will not be aware of the type of type of analgesia presented in the groups. They will be kept blind.