This study was a randomized prospective trial. After obtaining the code of the ethics committee, we selected women candidates for elective cesarean section based on inclusion and exclusion criteria. Then, we obtained informed consent from all of them. All women were in ASA I physical status. The research environment was the university hospitals of Rafsanjan University of Medical Sciences in 2020.
Two groups of women underwent spinal block with 2 types of needles, Whitacre 25 gauge, and Quincke 25 gauge. The women in the 2 groups had the same conditions such as the amount of fluid therapy during fasting, level of anesthesia T4 procedure (paramedian), fixed 0.05% heavy Marcaine drug with volume constant 3 to 3.5 cc, constant speed of infusion in intrathecal space, sitting position, and intervertebral space L3-L4 or L4-L5.
The sample size of this study was calculated with the level of confidence 0.95 and margin of error 0.5 (
20). The 130 women candidates for elective cesarean section were randomly divided into 2 equal groups. To this purpose, using the excel file and random between function, 65 numbers were randomly selected from numbers 1 - 130 according to the number of women entering the study to assign to the Whitacre group, and the remaining numbers were assigned to the Quincke group. All women were blinded to the type of needle.
To conduct this study, a checklist was designed for each parturient within 1 week after cesarean. We considered the primary outcome PDPH in the checklist. In the case of PDPH, secondary outcomes (such as the severity of PDPH, days of PDPH in the parturient, need to analgesic, and movement limitation) were evaluated for 1 week after surgery. Also, associated symptoms and signs (such as neck pain, shoulder pain, sensitivity to sound and light, nausea, and vomiting) were evaluated for 1 week after surgery. The Visual Analogue Scale (VAS) measurement was used to measure the severity of PDPH. In this method, the women who suffered from PDPH were asked to place a mark on the vertical line to detect the personal experience of pain, as shown in
Figure 1 (
21).
Criteria for measuring headache severity based on Visual Analogue Scale
Exclusion criteria included failure on the first try, failure to complete painless level need for cesarean, eclampsia, preeclampsia, refusal of spinal anesthesia by women, and women who entered the study but were not accessible to fill the checklist a week later.
The flow diagram of the studied women is reported in
Figure 2.
Flow diagram of the studied cases
The resulting data were analyzed using SPSS version 22 (SPSS Inc, Chicago, Ill, USA). The variables in this study include 2 categories: quantitative and qualitative variables. Quantitative variables include the mean severity of PDPH and day’s number of PDPH. Qualitative variables include the need for analgesia, movement limitation, and associated symptoms and signs, such as nausea, vomiting, and shoulder and neck pain. The quantitative variables were presented as mean ± SD, and the qualitative variables were presented as frequency and percentage. It should be noted that the studied indicators were compared only in the parturient with PDPH between the 2 groups.
The Kolmogorov-Smirnov test was used to evaluate the normality of the mean severity score of PDPH and the other quantitative indicators. The equality of variances in the groups was also evaluated by the Levene test. The t-test and related post-tests were used to compare the groups. In addition, to compare the incidence of PDPH and associated symptoms and signs in the 2 groups of parturients, the independent 2-sample t-test and Fisher exact test were used. A significant level of 5% (95% confidence interval) was considered.