|Year : 2019 | Volume
| Issue : 11 | Page : 1564-1569
A randomized study to evaluate post-dural puncture headache after cesarean section: Comparison with median and paramedian approaches
MS Uluer1, M Sargin2, F Akin3, E Uluer4, O Sahin1
1 Department of Anesthesiology and Reanimation, Konya Training and Research Hospital, Konya, Turkey
2 Department of Anesthesiology and Reanimation, Faculty of Medicine, Selcuk University, Konya, Turkey
3 Department of Anesthesiology and Reanimation, Erzurum Training and Research Hospital, Konya, Turkey
4 Department of Obstetrics and Gynecology, Dr. Ali Kemal Belviranlı Obstetrics and Pediatrics Hospital, Konya, Turkey
|Date of Submission||15-Feb-2019|
|Date of Acceptance||17-Jun-2019|
|Date of Web Publication||13-Nov-2019|
Dr. M S Uluer
Department of Anesthesiology and Reanimation, Konya Training and Research Hospital, Konya
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background: Although the most popular anesthesia technique for cesarean is spinal anesthesia, its most common complication is post-dural puncture headache (PDPH). Aim: We aimed to determine the effect of median and paramedian approaches during spinal anesthesia on PDPH in patients undergoing cesarean section. Subjects and Methods: 200 pregnant women between the ages of 19-45 years, ASA physical status II, scheduled to undergo elective cesarean section under spinal anesthesia, were studied. The patients were randomized into two groups: Group M; (n = 100) spinal anesthesia with the median approach, Group PM; (n = 100) spinal anesthesia with paramedian approach. The patients were questioned for the possible occurrence of PDPH on the first, third and seventh postoperative days. A telephone follow-up call was used if the hospital stay was shorter than seven days. Post-dural puncture headache was evaluated according to the International Classification of Headache Disorders (ICHD-III) diagnostic criteria. Normally distributed data were summarized using mean and standard deviation. Skewed data were summarized using median (range). Results: A total of 200 patients completed the study. There were no statistically different between the groups by comparing the incidence and characteristics of PDPH (32% vs. 28%, P = 0.548). Most patients rated their pain intensity during PDPH as mild to moderate in both groups (p = 0.721). PDPH onset time was 2 (1-4) days in Group PM versus 3 (1-7) days in Group M (p = 0.173). No patient needed for epidural blood patch in both groups. Conclusions: Spinal anesthesia with a median or paramedian approach at cesarean section has no effect on the incidence of PDPH, but we believe that there has been a need for further studies with larger or different patient populations.
Keywords: Headache, median, paramedian, post-dural puncture
|How to cite this article:|
Uluer M S, Sargin M, Akin F, Uluer E, Sahin O. A randomized study to evaluate post-dural puncture headache after cesarean section: Comparison with median and paramedian approaches. Niger J Clin Pract 2019;22:1564-9
|How to cite this URL:|
Uluer M S, Sargin M, Akin F, Uluer E, Sahin O. A randomized study to evaluate post-dural puncture headache after cesarean section: Comparison with median and paramedian approaches. Niger J Clin Pract [serial online] 2019 [cited 2020 Aug 11];22:1564-9. Available from: http://www.njcponline.com/text.asp?2019/22/11/1564/270846
| Introduction|| |
Although the most popular and common anesthesia technique for cesarean is spinal anesthesia, it has got several complications like post-dural puncture headache (PDPH)., This headache is typical changes with position and in a throbbing pattern also accompanied by photophobia and vision blurring. Unfortunately, the incidence of PDPH is higher in parturients compared to other patients., Post-dural puncture headache, the incidence of which varies from 0.5-25%, is one of the most significant complications after spinal anesthesia., Therefore, management of spinal anesthesia is very important for obstetric anesthesiologists. The PDPH mechanism must be well understood for the management of preoperative prophylactic preventive (medication, needle preference, needle bevel direction, etc.) and therapeutic options. The mechanism of PDPH is not clear, but the leakage of cerebrospinal fluid (CSF) from the dural hole is the traditional theory. Although the precise mechanism of PDPH has not been elucidated, some high-risk factors for developing PDPH have been found, including female sex, young age, the needle size and design, the needle bevel direction and a previous history of PDPH., As the size of the needle increases, the risk of PDPH increases.
We evaluated the comparison with median and paramedian approaches on PDPH after cesarean section in this prospective, randomized and double-blind trial. In this study, we hypothesized that the post-dural puncture headache could develop less with the paramedian approach due to the entrance angle of the needle.
| Methods|| |
Institutional ethics committee approval and written from the patients were obtained for the study. It has been registered with the Australian New Zealand Clinical Trial Registry (ACTRN12616000165482). 200 pregnant, gestational age 38-40, between the ages of 19-45 years, ASA physical status II, scheduled to undergo elective cesarean section under spinal anesthesia, were studied.
Exclusion criteria were a contraindication to neuraxial anesthesia or known allergy to bupivacaine, spinal puncture failure or a need for additional intraoperative analgesia, body mass index (BMI) > 35 kg/m 2, general anesthesia or epidural anesthesia, multiple gestations, emergency CS and preoperative presence of any other abdominal mass or ascites. Patients with more than one trial for spinal anesthesia, previous PDPH, chronic headache, pregnancy-induced hypertension, preeclampsia, eclampsia, gestational diabetes, macrosomic infants, intrauterine growth retardation and small for gestational age were also excluded from the present study.
The patients were randomized by using computer-generated block randomization into two parallel groups: Group M; (n = 100) spinal anesthesia with the median approach, and Group PM; (n = 100) spinal anesthesia with the paramedian approach.
All patients were expected to fast 6-8 hours before CS, and no one was premeditated. Routine monitors (consisting of a pulse oximeter, 3-lead ECG and a non-invasive blood pressure cuff) were applied. Baseline measurements were obtained while patients were the supine position. Following rehydration with Ringer's lactate solution 500 mL, spinal anesthesia was induced with hyperbaric bupivacaine 10-15 mg via a 25 G Quincke-tip spinal needle (Egemen, Turkey) in the sitting position at the L3–4 or L4-5 vertebral level using median and paramedian approaches by an anesthesiologist with more than 5 years' experience (MSU). Patients were then positioned in a 10-15° left-lateral tilt; in this way, 15° left uterine displacement was provided. Surgery was initiated when the sensory block level reached at T4. Patients' demographic data (age, weight, height, BMI), duration of surgery, number of hypotensive episodes, total ephedrine requirements and intraoperative nausea and vomiting were also noted. Hypotension was defined as a decrease in SBP of >30% below baseline or to <90 mmHg and was treated by increasing the rate of crystalloid infusion. If hypotension persisted, a bolus of iv ephedrine 5 mg was given.
Postoperative analgesia protocol was as follows: Contramal 2 mg/kg, iv, 12 hours apart, paracetamol 10 mg/kg, iv, was applied when analgesia was inadequate despite contramal.
The patients were questioned for the possible occurrence of PDPH on the first, third and seventh postoperative days. A telephone follows up call was used if the hospital stay was shorter than seven days. Post-dural puncture headache was evaluated according to the International Classification of Headache Disorders (ICHD-II) diagnostic criteria. The intensity of headache and puncture pain was assessed on a scale of 0 to 10, where 0 means no pain and 10 the worst possible pain (0 no, 1–3 mild, 4–6 moderate, 7–10 severe). Also, hearing loss, tinnitus, photophobia, nausea, and vomiting were recorded. Any treatment for the headache was recorded. Post-dural puncture headache evaluations were performed by a different anesthesiologist blinded to the study.
To ensure that the sample sizes of the study groups would support a valid comparison, a power analysis (G*Power 3.1, Düsseldorf, Germany), based on a similar previous study, was performed (α = 0.05, β = 0.80), which indicated that at least 95 subjects should be recruited for each group to reduce the incidence of PDPH by one-third. Therefore, we recruited 200 patients in total to account for possible drop-outs.
Statistical analyses were performed with SPSS 15.0 software (SPSS Institute, Chicago, IL, USA). Continuous data were tested for normality. Normally distributed data were summarized using mean and standard deviation. Skewed data were summarized using median (range). Categorical data were summarized using number and proportion. A P value of less than 0.05 was considered statistically significant.
| Results|| |
A total of 200 patients completed the study [Figure 1]. Patients' demographic data and intraoperative clinical features are summarised in [Table 1] and there were no significant differences between the two groups regarding age, weight, height, body mass index (BMI), operation time, local anesthetic dose, hypotensive episodes, total ephedrine requirements and intraoperative nausea and vomiting (P = 0.064, P = 0.611, P = 0.056, P = 0.157, P = 0.923, P = 0.414, P = 0.876, P = 0.520 and 0.705, respectively).
|Table 1: Comparison of patients' baseline characteristics and intraoperative clinical features between the groups|
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Comparison of incidence and characteristics of post-dural puncture headache between the groups are summarised in [Table 2]. Thirty-two (32/100 32%) of the patients in Group M and twenty-eight (28/100, 28%) of the patients in Group PM, developed post-dural puncture headache. There were no statistically different between the groups (p = 0.548). In group M, the maximum VAS value ranged from 1 to 3 (mild pain) in 17 of the patients with PDPH, and the maximum VAS value ranged from 4-7 (moderate pain) in 15 of the patients with PDPH. In group PM, the maximum VAS value ranged from 1 to 3 (mild pain) in 16 of the patients with PDPH, and the maximum VAS value ranged from 4-7 (moderate pain) in 12 of the patients with PDPH. No severe (VAS value >7) PDPH developed in any of the two groups. When the pain severity was compared between the groups, no statistical difference was found (p = 0.721). In group M, the number of patients requiring treatment due to PDPH was 29, and in Group PM it was 25. There was no statistically significant difference between the groups (p = 0.591). No blood patch was needed for treatment in any patient. When the onset time of the pain was compared, there was no difference between the groups too (p = 0.173).
|Table 2: Comparison of incidence and characteristics of post-dural puncture headache between the groups|
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| Discussion|| |
In this study, the incidence of PDPH after cesarean section with spinal anesthesia was found to be 32% in patients who received spinal anesthesia with the median approach, and 28% in patients who received spinal anesthesia with the paramedian approach. Administration of spinal anesthesia, with either the paramedian or median approach found to have no effect on PDPH.
The risk factors for PDPH, which is the most commonly observed complication of spinal anesthesia, are classified as non-modifiable and modifiable. In our study, the most critical factors affecting the incidence of PDPH were the non-modifiable risk factors of age and female sex and the modifiable risk factors of spinal needle characteristics and orientation. Post-dural puncture headache is less common in children and the elderly compared with adults aged 20 to 40. Post-dural puncture headache is two times more frequently in non-pregnant women than among males. Obstetric patients are particularly at high risk of PDPH due to their age and sex. For this reason, PDPH is the most common complication in neuraxial block-receiving pregnant women. A wide range of studies has been carried out to address this problem, which is mainly related to spinal needles, the patient's position, fluid therapy and prophylactic drugs.,,
In a study by Amorim et al., in which various risk factors of PDPH were studied; comparisons were made based on sex, age, needle size, orientation of the needle bevel parallel or perpendicular to the dural fibers, previous PDPH history of the patients, and the use of the median or paramedian approach, and all factors except for the last were reported to have an impact on PDPH. Although our study population was different and represented a specific group, our results similarly demonstrated that the use of the paramedian and median approaches do not result in any differences with regards to PDPH occurrence.
In another study conducted on patients who underwent orthopedic surgery, which compared the effect of the median and paramedian approaches on the incidence of PDPH, no statistically significant difference was observed between the two methods. In the said article, the authors reported that the paramedian approach is useful for older adults and individuals with degenerative changes. Although the study used a different patient group compared to the one in our study, the two study's results were similar in that both approaches did not affect the incidence of PDPH.
Another study carried out in previous years had obtained results which were different from the present study. In a study by Janick et al., the effects of the median and paramedian approaches on the incidence of PDPH were compared in 250 patients aged 50-85 years who had undergone transurethral resection of the prostate under spinal anesthesia. At the end of the study, significantly higher PDPH rates were observed in the patient group aged 50-60 years with the paramedian approach when compared with median approach. However, no significant difference was observed at older ages. Unlike in the present study and other studies, spinal anesthesia in Janick et al.'s study was applied in the sitting position for the patients in the median group, and in the lateral decubitus position for patients in the paramedian group. There are studies stating that this difference between the groups may affect the incidence of PDPH. In a meta-analysis study emphasizing this difference, lateral decubitus position was reported to be a good alternative for the prevention of PDPH.
In an in vitro study that we consider might be relevant to our topic, the designs and angles of the introduction of different epidural needles, as well as their perpendicular or parallel orientation to the dural fibers and their effects on the CSF leakage, were investigated experimentally. In this study, the authors reported no statistically significant difference in fluid leak between the dural puncture of a cadaver at 30° and 90°. In our clinical study, we concluded that there was no statistically significant difference in PDPH due to dural puncture from different angles in the median and paramedian approaches.
In our study, we used a 25 G Quincke spinal needle and directed the sharp bevel of the needle to the spinal axis. In a study by Nafiu et al. that included the same study population as in the present study, the authors compared the effects of three different gauge Quincke spinal needles (25 G, 22 G, and 26 G) on PDPH. The highest level of headache was observed in patients on whom the 22 G Quincke needle was used (33%), while 4% to 5% lower rates were reported in patients on whom the other two spinal needles were used. In the conclusion part of their study, the authors suggested that 22 G Quincke needle should not be used in the obstetric patient group, and recommended small caliber pencil point needles despite their higher cost. In this study and many other articles, a close relationship was reported between PDPH and the caliber of the spinal needle. Another study on an obstetric patient group studied the effects of five different spinal needles – including the 25 G Quincke spinal needle – on the incidence of PDPH and epidural blood patch need. Pencil point needles were recommended for subarachnoid anesthesia in the obstetric patient group. The study suggested that the lower incidence of PDPH in anesthesia performed with blunt-ended needles compared to the ones performed with sharp-ended Quincke needles was due to the plug effect, which prevented the CFS leak of the inflammation resulting from the more traumatic effect on the dura mater. The direction of the tip of the needle – in other words, whether it is perpendicular or parallel to the spinal axis – is another risk factor for headache. In a meta-analysis on this issue, sharp-ended spinal needles were reported to reduce the incidence of PDPH when they were directed parallel to the spinal axis instead of perpendicular; however, the reason behind this effect remains unclear. Furthermore, a recently published study emphasized arachnoid damage during PDPH, also, dura mater damage, drawing attention to a more complex underlying process.
In our study, we have chosen a 25 G Quincke spinal needle, since it is less costly and frequently used for subarachnoid anesthesia in different surgical interventions in our clinic, and also because the main objective of our study was to compare median and paramedian approaches rather than the effects of needle properties on the incidence of PDPH. We think that the high rate of PDPH in this study is due to this type of needle used. Although this seems to be a limitation, we believe that the main objective of this study did not change the purpose. Also, another limitation in the present study was that we didn't use intrathecal opioid and instead used tramadol for the postoperative analgesia.
| Conclusion|| |
In conclusion, we believe that the application of spinal anesthesia with the median or paramedian approach for cesarean section surgery does not effect on the incidence of PDPH. However, we also consider that there is a need for more extensive studies on this subject, involving different patient populations.
The research is self-funded.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2]