Comparison of the effect of intravenous Dexamethasone injection with Intrathecal injection On Pain and Nausea and Vomiting of patients undergoing Caesarean section by Spinal anesthesia with Sufentanil; a double-blind randomized clinical trial

Comparison of the effect of intravenous and intrathecal dexamethasone injection on pain and nausea and vomiting in patients undergoing cesarean section.

Double-Blind Randomized Clinical Trial, Phase 3 on 90 patients, Web-based randomization software was used for randomization.

The present study will be conducted in the field of reducing pain and nausea and vomiting in 90 patients aged 20-40 who are candidates for caesarean section by spinal anesthesia in Bent Al Hodi Hospital. Patients are divided into three groups in a blocked random allocation using the web-based system. Evaluation of the intensity of pain, nausea and vomiting of patients using the VAS tool during recovery, 30 minutes after the operation, then every 30 minutes, then 6 hours, 12 hours , 24 hours after the operation.

Inclusion criteria: The patient should be alert, should be a candidate for cesarean surgery with spinal anesthesia, Patient should not have the Absolute contraindications for spinal anesthesia. Exclusion criteria: Dissatisfaction of patients during intervention, the requirement of general anesthesia after spinal anesthesia for the patient.

In the first group(A): Patients in combination with the main drug (Bupivacaine); They will receive Sufentanil 25 micrograms and 8mg Dexamethasone Intrathecal (2cc). In the second group(B): Patients in combination with the main drug (Bupivacaine); 25 micrograms Sufentanil and immediately after doing spinal; All patients will receive 8mg of dexamethasone (2cc) intravenously. In the third group(C): patients in combination with the main drug (bupivacaine); Sufentanil 25 micrograms and 2cc of intrathecal distilled water will be given. Also, immediately after doing the spinal; All patients will receive 2cc of distilled water intravenously.

Pain, nausea and vomiting

Sampling in this study will be that first in order to enter the study patients will be in the form of non-random sampling of the type "available" and then divide them into three groups by randomly assigned blocking using a web-based system. Random blocking at www.randomization.com will be done in 15 blocks of 6. So that in each block, there are 2 people in the first group (A), two people in the second group (B) and two people in the third group (C). After a random sequence was identified in all blocks, cards were written by writing C, B, and A to indicate which group each patient was assigned to, and by someone other than the research team from 1 to 90 in all blocks, respectively. They are numbered and these cards are placed in sealed non-transparent envelopes, respectively. Then, in order to hide the random allocation, when the patient visits, the opaque sealed envelope will be opened and then one by one, it will be determined for each sample of the relevant group.

None of the participants in the study will be aware of the randomization list, and in order to conceal the randomization process, the groups will be placed in closed envelopes in the reception area and will be assigned to the eligible individuals who enter the study. Also, to blind the patients to the study groups, all patients will receive all the interventions of the same groups with placebo. in order to make the study double-blind, the data will be measured and recorded by a person who is unaware of the groupings. Also, the preparation of drugs in each group is done by an anesthesiologist, and another anesthesiologist will perform the spinal block, who is unaware of the drugs in each syringe.

There is no further information.