Comparison of ginger suppository and placebo on headache and chills after spinal anesthesia in cesarean section patients

The effect of ginger suppository on the treatment of headache and chills after spinal anesthesia in cesarean section patients

This study has two groups (intervention group and control group) and is a single blind randomized clinical trial. Randomization is a probabilistic method with quadruple balanced blocks that is performed by a software. The sample size was calculated based on G_ POWER software (50 people in each group). The clinical trial phase is 3.

This study will be performed in the Women's Referral Hospital (Kamali Hospital) in Karaj. This study is a parallel and single blind randomized clinical trial. Patients do not know which drug is the main drug and which is the placebo. In the intervention group main drug (ginger suppository) will be used. In the control group, a placebo is used, which is like the main drug in all aspects such as smell, color and weight. In each group, pain intensity will be measured at 6 time points (0.5, 1, 1.5, 3, 6, 12 hours) after the operation. The severity of chills is recorded from 20 to 95 minutes after cesarean section, every 15 minutes for one minute.

Inclusion criteria: age 15-49 years, full-term pregnancy (37 full weeks of pregnancy), singleton pregnancy, anesthesia class ASA Ι- ASA II, non-emergency cesarean section, headache in the first 72 hours. Non-inclusion criteria: prolonged cesarean section (more than one hour), ginger allergy, use of psychotropic drugs

The main drug (ginger suppository) will be used in the intervention group. In the control group, a placebo is used, which is like the main drug in all aspects (smell, color, weight).

The severity of headache; the severity of chills

First, a list of eligible people is prepared in Excel software. Then, the subjects are divided into two groups of intervention and control by block randomization method with 4 equal blocks, which is done with websites( www.randomization.com can do block randomization more easily). In this method, the size of all blocks is equal. In this study, with a 100 sample size, the number of blocks is 4 and the size of each block is 25. Two blocks (50 people) belong to an intervention group and two blocks (50 people) belong to the control group.

This study is single blind. The patient does not know which drug is the main drug and which is the placebo. The intervention group is given the main drug and the control group is given the placebo. The color, smell, weight, and other characteristics of the placebo are as the same as the main drug.

All data is potentially shareable after unidentified individuals.

"Access period starts 6 months after the results are published".

Our data will be available to researchers working in academic and scientific institutions, or to people who are also involved in the industry.

Receive documentation from them based on the academic degree or employment in the industry.

Call this phone number: 00989124195752

After the accuracy of the submitted documents, the data will be sent within a maximum of 2 weeks.