Comparison of adding sufentanil and dexamethasone to ropivacaine 0.1% in painless labor with epidural anesthesia

Comparison of the effect of adding Sufentanil and Dexamethasone to Ropivacaine 0.1% in painless labor using epidural anesthesia.

Clinical trial without control group, with parallel-groups, double-blind, randomized, phase 3 clinical trial on 104 patients. Randomization.com online software and block randomization method will be used for randomization.

In this study, the number of 104 term pregnant patients who are candidates for natural pain-free delivery in Taleghani Hospital in Arak city will be studied. Patients are randomly divided by the anesthesiologist into A and B groups. In both groups, the drugs used for the intervention are the same in terms of transparency and color, and the anesthesiologist labeled each of them A and B. The used syringes are also of the same shape, same color, and completely similar, and in order to comply with blinding, the volume of 10 cc is brought by the anesthetist so that they will not be able to identify the contents of the solution from their appearance. The patients and the intern responsible for evaluating the patients were not aware of the type of groups and therefore the plan will be implemented in a double-blind manner.

Inclusion criteria: term pregnancy, singleton pregnancy. Exclusion criteria: heart, lung, kidney and liver diseases, allergy to used drugs, coagulopathy, spinal deformity

In the first intervention group, 8 mg of dexamethasone (Alborz Daru-Iran) which was increased to 10 cc with 0.1% ropivacaine (Darman Yab Daru-Iran) and in the second intervention group, 0.25 mg per cc of the drug Sufentanil (Daroopakhsh-Iran) mixed with 10 cc of Ropivacaine 0.1% (DarmanYab Daro-Iran) will be slowly injected by the anesthesiologist in the epidural space.

Duration of painlessness, headache, nausea and vomiting

In this study, we will use the restricted randomization method of the block randomization type. The size of all the blocks is equal and due to having two groups, there should be an equal number of states A and B in each block, which due to the volume of four blocks, there were six different states for the blocks, which are: AABB, ABAB, ABBA BBAA, BABA, BAAB. In order to conceal, we use allocation concealment, which refers to the method used to perform a random sequence on the participants in the study, so that the allocated group is not known before the allocation of the individual. The cards randomly and by re-replacing the selection and order of the blocks determine the order of placing the patients in groups A and B. A person who has no knowledge about the research will be used to select the cards on which the six states of blocks of four were written.

In this study, in order to observe the blinding of the patients, the anesthesiologist will completely randomly divide them into two groups receiving the mixture of ropivacaine and dexamethasone (group A) and the mixture of ropivacaine and fentanyl (group B). In both groups, the drugs used for the intervention are the same in terms of transparency and color, and the anesthesiologist has labeled each of them A and B. The syringes used are also the same shape, the same color, and completely similar, and to comply with blinding, the volume is 10 cc. It is delivered by the anesthesiologist in such a way that the anesthesiologist and patients and the intern responsible for data recording will not be able to identify the content of the solution from their appearance. The intern responsible for the project did not know the type of study groups from the beginning and is only responsible for filling out the questionnaires of the project and therefore the project will be implemented in a double-blind manner. In other words, the patient and the anesthesiologist responsible for drug injection and the intern responsible for data recording will be blind.