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This study is designed to assess possible relation between the anthropometric data of pregnant women at term, as well as their babies, and the maximal level of sensory blockade following spinal anesthesia for cesarean section. The debate regarding this relation is ongoing. Although there is some relevant data in favor of both lack and the presence of significant relation between these variables, it is still not clear whether the same dose of local anesthetic is similarly effective, regardless of parturient's and fetal size.
Spinal block is a gold standard of cesarean section anesthesia. Two major factors contribute to its popularity: more than satisfactory level of surgical conditions and the fact that the mother is able to witness the birth of her child and both of them can benefit from skin-to-skin contact. For the procedure to proceed with patient's comfort the level of sensory block is required to be adequately high, reaching high thoracic dermatomes.
For this reason the quest for the ideal dose of local anesthetic is still ongoing. A few strategies has been proposed. Adjusting the dose to patient's size is probably the most popular. In order to minimize the risk of spinal block - related complications and maintain acceptable level of effectiveness, it was suggested that height, weight, maternal weight gain, abdominal circumference or combination of these variables may be used to calculate the appropriate spinal dose of hyperbaric bupivacaine.
In this study we will investigate whether demographic variables relate to maximal level of spinal sensory blockade when the same high dose of local anesthetic is used (close to the dose effective in 95% of cases (ED95)).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parturients given spinal block with 12.5mg of hyperbaric bupivacaine | Hospital's electronic database will be searched in order to identify elective cases of cesarean sections performed under spinal anesthesia. After that, a manual review of each case will follow and only those where the dose of hyperbaric bupivacaine used for spinal block was 12.5mg will be chosen for further analysis. Anesthetic records of these cases will be retrieved and assessed for its quality, clarity and completeness. During the process of further analysis an anonymized data will be retrieved and moved to Excel file: demographic and pregnancy - related data of the parturient, spinal block - related data (technique and dynamic of the sensory blockade, maternal hemodynamic parameters) and neonatal data (birthweight). Special attention will be paid to assure that all data is accessible only for investigators and remain anonymous throughout the analysis process. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal block level analysis | Other | Relation of pregnancy - related, maternal and neonatal data to the level of sensory blockade in the whole study group will be assessed. Only cases with 12.5mg of hyperbaric bupivacaine will be included. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessed variable - block level correlation coefficient | Regression and correlation analysis will be employed to assess the relation between pregnancy-related, maternal and neonatal data and the level of sensory block. For the purpose of statistical analysis the level of block will be converted into numbers for more reliable outcome. | Highest level of sensory block noted from the time of spinal injection until the end of surgical procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Study population will be chosen from the cases of elective cesarean sections that took place in years 2017-2022 in Orlowski Hospital, Department of Obstetrics and Gynecology, Centre of Postgraduate Medical Education, Warsaw, Poland. Intention is to include at least 140 cases for good quality analysis
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| Name | Affiliation | Role |
|---|---|---|
| Małgorzata Malec-Milewska, MD, Prof. | Department of Anesthesia and Intensive Care, Orlowski Hospital, Warsaw | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre of Postgraduate Medical Education,Department of Anesthesia and Intensive Care | Warsaw | 01-813 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25499016 | Background | Ozkan Seyhan T, Orhan-Sungur M, Basaran B, Savran Karadeniz M, Demircan F, Xu Z, Sessler DI. The effect of intra-abdominal pressure on sensory block level of single-shot spinal anesthesia for cesarean section: an observational study. Int J Obstet Anesth. 2015 Feb;24(1):35-40. doi: 10.1016/j.ijoa.2014.08.004. Epub 2014 Aug 27. | |
| 33171677 |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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| Data collection | Other | Intervention is to retrieve and analyse anonymous perioperative data. After identification of eligible cases, statistical analysis will be performed |
|
| Sub-group analysis | Other | Relation of pregnancy - related, maternal and neonatal data to the level of sensory blockade in the sub-groups of different height (<165cm and >165cm) will also be performed. |
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| Bialowolska K, Horosz B, Sekowska A, Malec-Milewska M. Fixed Dose versus Height-Adjusted Conventional Dose of Intrathecal Hyperbaric Bupivacaine for Caesarean Delivery: A Prospective, Double-Blinded Randomised Trial. J Clin Med. 2020 Nov 8;9(11):3600. doi: 10.3390/jcm9113600. |
| 28834913 | Background | Wei CN, Zhou QH, Wang LZ. Abdominal girth and vertebral column length aid in predicting intrathecal hyperbaric bupivacaine dose for elective cesarean section. Medicine (Baltimore). 2017 Aug;96(34):e7905. doi: 10.1097/MD.0000000000007905. |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |