Comparison of the duration of spinal anesthesia in elective cesarean section in Trendelenburg and reverse Trendelenburg positions

Comparison of the duration of spinal anesthesia in elective caesarean section candidates in Trendelenburg and Reverse Trendelenburg positions in Kamali Hospital

Randomized clinical trial without control group, with parallel groups, without blinding, on 60 patients. For randomization, the samples are assigned to two groups using the block randomization method with unequal block sizes (4,6,8).

The number of samples is 60 patients who will be randomly divided into two groups of 30 people. After receiving spinal anesthesia, the first group will be placed in the 10-degree Trellandenberg position, and the second group will be placed in the 10-degree reverse Trellandenberg position after receiving spinal anesthesia. The duration of spinal anesthesia in minutes will be recorded and compared in two groups.

Age 20-45, height range 155-170 cm and ASAII will be performed. Termination of pregnancy should be during term (37-42 weeks). The patient should undergo spinal anesthesia. The pregnant mother has not used any special drugs. The pregnant mother does not have any underlying disease. The mother does not have any drug addiction. BMI should be less than 30.

Trendelenburg and reverse Trendelenburg positions

1) Duration of spinal anesthesia

In block randomization, in order to hide the allocation process, which is the most important principle in randomized clinical trials, the size of the blocks is considered unequal. Blocking is used in order to balance the number of samples allocated to each of the studied groups. This feature helps researchers to ensure that the number of samples allocated to each of the study groups is equal in cases where intermediate analyzes are needed during the sampling process. Blocking is done in two ways: in the first method, the size of all blocks is equal (for example, in a two-group experiment, blocks of 8 including 4 participants in the intervention group and 4 participants in the control group) and in the second method, the size of the block are randomly selected (for example: blocks of 8, 6, 10 and 14 in which there are equal numbers of each group in each block).The purpose of block randomization is to make sure that an equal number of participants enter the intervention and control groups at consecutive but equal time intervals.The samples will be randomly assigned to one of two groups. For randomization, the block randomization method with unequal block sizes (4, 6, and 8 blocks) will be used {to equalize the volume of samples in two groups and hide the allocation process}. To prepare the list, the web software at the following internet address will be used (by giving the required inputs, including the total sample size and the size of the blocks). This list is only in the hands of the researcher who has no role in the allocation and evaluation of the results.In this method, each random sequence is created and recorded on a card, and the cards are placed in the envelopes in order. In order to maintain a random sequence, the numbering on the outer surface of the envelopes is done in the same order and it is pasted in the letter envelopes and placed inside a box. At the beginning of the registration of the participants, one of the letter envelopes, the flow of the order of entry of the qualified participants into the study, will be opened and the time group of that company will be revealed. https://www.sealedenvelope.com/simple-randomiser/v1/lists

All the data and results of the study will be available after de-identification as a thesis in the library resource of Alborz University of Medical Sciences.

The access period starts 6 months after the results are published

Researchers working in academic and scientific institutions

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