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Our hypothesis is that the bupivacaine dose determined according to the thoracolumbar vertebral body length (VBL) is more effective in achieving a lower hypotension rate during spinal anesthesia for cesarean delivery than the dose usually adjusted based on height and weight. The VBL measurements were determined from the midpoint of C7 to the tuffier line L4 spinous process.
Method: Patients ranging in height from 150 to 170 were randomly assigned to either Group 1 (0.2 mg of 0.5% hyperbaric bupivacaine per cm VBL or Group 2 (height-adjusted dose of 0.5% hyperbaric bupivacaine based on a minimum dose of 0.065 mg/cm according to height) or Group 3 (height-adjusted dose of 0.5% hyperbaric bupivacaine based on a minimum height-adjusted dose of 0.065 mg/cm).
The study followed a parallel study strategy. Patients provided informed permission before the procedure. The study was randomly assigned and blinded. The study was conducted from April 2025 to December 2025. Patients with pre-existing or pregnancy-induced hypertension, cardiovascular or cerebrovascular disease, contraindications to spinal anesthesia, weighing < 50 kg or > 110 kg, and heights higher than 170 cm or shorter than 150 cm were eliminated. Informed written consent was acquired from all patients participating in the trial. Each patient was evaluated for vital parameters and possible complications at 3-minute intervals before and after the spinal anesthesia application, treated if necessary, and recorded. The study was concluded at the end of the cesarean section.
There was no premeditation among the patients. The patient had standard monitoring, including non-invasive blood pressure, ECG, and pulse oximetry, with recorded baseline blood pressure and heart rate measurements. We inserted two 20-gauge intravenous cannulas and administered an IV-balanced solution using these routes. The patients' age, height, weight, ASA class, and VBL (C7-L4 Tuffier line cm) were recorded. The Tuffier's line (TL), which is made by drawing a horizontal line across the tops of the iliac crests, is the most common anatomical landmark right now. It has been shown to match up with the L4-L5 interspace or the L4 spinous process.
After skin infiltration with 2% lidocaine, a 25-gauge short-bevel Quincke spinal needle was placed at the L3-4 vertebral interspace with the patient in a sitting position. After aspiration of cerebrospinal fluid, the following anesthetic solutions were delivered over 5 seconds. Randomization was used to divide the patients into three groups. The trial was double-blind, with the patient and assessor unconscious of their group allocation. Only the practitioner delivering the spinal anesthesia was aware of the group allocation. Systolic, diastolic, and mean arterial blood pressure and heart rate were documented at baseline and assessed at 3-minute intervals, commencing 3 minutes post-spinal injection and persisting until the initiation of surgical procedures, after which measurements were conducted at 3-minute intervals.
Patients in Group VBL (Vertebral Body Length) received 0.2 mg x VBL cm of 0.5% hyperbaric bupivacaine. In contrast, Group FD (fixed dose) received a 0.5% hyperbaric bupivacaine volume based on a dose calculated according to the patient's height of 0.065 mg/cm. Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight. A dosage was derived using Harten's dose chart formulated for Caucasian parturients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group VBL (Vertebral body length) received 0.2 mg x VBL cm of %0.5 hyperbaric bupivacaine, | Active Comparator | Patients in Group VBL (Vertebral body length) received 0.2 mg x VBL cm of 0.5% hyperbaric bupivacaine |
|
| Group FD (fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated ac | Active Comparator | Group FD (fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated according to the patient's height 0.065 mg/cm |
|
| Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height | Active Comparator | Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group VBL (Thoracolumbal vertebral body length) received 0.2 mg x VBL cm of %0.5 hyperbaric bupivacaine | Procedure | intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight. A dosage was derived using Harten's dose chart formulated for Caucasian parturients |
| Measure | Description | Time Frame |
|---|---|---|
| Hypotension Rate Among the Groups | Maternal hypotension was defined as a decrease in systolic blood pressure of more than 20% from baseline or a systolic blood pressure <90 mmHg. The incidence of hypotension was recorded intraoperatively for each participant. | From initiation of spinal anesthesia to completion of surgery, during the intraoperative period (mean duration approximately 60-90 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kudret Dogru, Prof. Dr. | TC Erciyes University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kudret Doğru | Kayseri | Melikgazi | 38050 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27066205 | Background | Siddiqui KM, Ali MA, Ullah H. Comparison of spinal anesthesia dosage based on height and weight versus height alone in patients undergoing elective cesarean section. Korean J Anesthesiol. 2016 Apr;69(2):143-8. doi: 10.4097/kjae.2016.69.2.143. Epub 2016 Mar 30. | |
| 29090733 | Background | Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available. |
| Label | URL |
|---|---|
| National Library Medicine | View source |
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1. Eclampsia, those with preeclampsia 2. Those who underwent an emergency cesarean section 3. Those with bleeding diathesis and those on anticoagulant therapy 4. Patients with a history of carotid artery stenosis, 5. Cardiovascular disease, 6. Hypertension, 7. Chronic obstructive pulmonary disease, 8. Heart rhythm other than sinus rhythm, 9. Patients with a history of cerebrovascular disease. 10. Alcoholism or psychiatric illness 11. Placenta previa, accreta, and percreta.
1. American Society of Anesthesiologists (ASA) Class II 2. Regular antenatal visits 3. Singleton pregnancy at ≥37 weeks gestation 4. Pregnant women aged 18-45
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| ID | Title | Description |
|---|---|---|
| FG000 | Group VBL (Vertebral Body Length) Received 0.2 mg x VBL cm of %0.5 Hyperbaric Bupivacaine, | Patients in Group VBL (Vertebral body length) received 0.2 mg x VBL cm of 0.5% hyperbaric bupivacaine Group VBL (Thoracolumbal vertebral body length) received 0.2 mg x VBL cm of %0.5 hyperbaric bupivacaine: intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight. A dosage was derived using Harten's dose chart formulated for Caucasian parturients |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 5, 2025 |
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|
| Group FD (fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated according to the patient's height 0.065 mg/cm | Procedure | Group FD (fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated according to the patient's height 0.065 mg/cm |
|
| Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight. | Procedure | Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight. |
|
| 33456918 | Background | Bower JR, Kinsella SM. Preventing and treating hypotension during spinal anaesthesia for caesarean section. BJA Educ. 2020 Nov;20(11):360-361. doi: 10.1016/j.bjae.2020.08.001. Epub 2020 Sep 9. No abstract available. |
| 1599111 | Background | Carpenter RL, Caplan RA, Brown DL, Stephenson C, Wu R. Incidence and risk factors for side effects of spinal anesthesia. Anesthesiology. 1992 Jun;76(6):906-16. doi: 10.1097/00000542-199206000-00006. |
| National Library Medicine | View source |
| FG001 | Group FD (Fixed Dose) Received 0.065 mg/cm 0.5% Hyperbaric Bupivacaine | Group FD (Fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated according to the patient's height 0.065 mg/cm Group FD (Fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated according to the patient's height 0.065 mg/cm: Group FD (Fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated according to the patient's height 0.065 mg/cm |
| FG002 | Group AD (Adjusted Dosage) Received Heavy Bupivacaine (0.5%) Patient's Height and Weight | Group AD (adjusted dosage) received intrathecal heavy bupivacaine (0.5%) based on the patient's height and weight. Group AD (Adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight : Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight. |
| COMPLETED |
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| NOT COMPLETED |
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Baseline characteristics were assessed in the per-protocol population. Of the 446 participants who started the study, 255 (85 in each group) completed the study without major protocol deviations or conversion to general anesthesia and were included in the baseline and outcome analyses. Baseline data were collected prospectively; however, only participants who completed the study per protocol were included in the baseline analysis to ensure consistency with outcome analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group VBL (Vertebral Body Length) Received 0.2 mg x VBL cm of %0.5 Hyperbaric Bupivacaine, | Patients in Group VBL (Vertebral body length) received 0.2 mg x VBL cm of 0.5% hyperbaric bupivacaine Group VBL (Thoracolumbal vertebral body length) received 0.2 mg x VBL cm of %0.5 hyperbaric bupivacaine: intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight. A dosage was derived using Harten's dose chart formulated for Caucasian parturients |
| BG001 | Group FD (Fixed Dose) Received a Volume of 0.5% Hyperbaric Bupivacaine Based on a Dose Calculated ac | Group FD (fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated according to the patient's height 0.065 mg/cm Group FD (fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated according to the patient's height 0.065 mg/cm: Group FD (fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated according to the patient's height 0.065 mg/cm |
| BG002 | Group AD (Adjusted Dosage) Got Intrathecal Heavy Bupivacaine (0.5%) Tailored to the Patient's Height | Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight.: Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | A total of 255 patients include in the study, 85 patients analysed in each group. (excluding patients with protocol violations or conversion to general anesthesia)169 patients not meeting inclusion criteria, 13 patients declined to participate (total 182) and 88 patients allocated. Nine patients (three from each group) were excluded from the final analysis due to protocol violations or conversion to general anaesthesia. | Count of Participants | Participants |
| |||||||||||||||
| Age, Continuous | Analysis was performed on a per-protocol basis, excluding patients (64 in Group 1, 64 in Group 2, and 63 in Group 3) who violated the protocol or converted to general anesthesia. | Mean | Standard Deviation | yr |
| ||||||||||||||
| Sex: Female, Male | A total of 255 patients include in the study, 85 patients analysed in each group. 169 patients not meeting inclusion criteria, 13 patients declined to participate (total 182) and 88 patients allocated. Nine patients (three from each group) were excluded from the final analysis due to protocol violations or conversion to general anaesthesia. | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | people from the Anatolian / Middle Eastern | Analysis was performed on a per-protocol basis, excluding patients with protocol violations or conversion to general anesthesia. | Count of Participants | Participants |
| ||||||||||||||
| Region of Enrollment | Analysis was performed on a per-protocol basis, excluding patients with protocol violations or conversion to general anesthesia. | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hypotension Rate Among the Groups | Maternal hypotension was defined as a decrease in systolic blood pressure of more than 20% from baseline or a systolic blood pressure <90 mmHg. The incidence of hypotension was recorded intraoperatively for each participant. | Cesarean delivery patients | Posted | Count of Participants | Participants | From initiation of spinal anesthesia to completion of surgery, during the intraoperative period (mean duration approximately 60-90 minutes) |
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6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group VBL (Vertebral Body Length) Received 0.2 mg x VBL cm of %0.5 Hyperbaric Bupivacaine, | Patients in Group VBL (Vertebral body length) received 0.2 mg x VBL cm of 0.5% hyperbaric bupivacaine Group VBL (Thoracolumbal vertebral body length) received 0.2 mg x VBL cm of %0.5 hyperbaric bupivacaine: intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight. A dosage was derived using Harten's dose chart formulated for Caucasian parturients | 0 | 85 | 9 | 85 | 0 | 85 |
| EG001 | Group FD (Fixed Dose) Received a Volume of 0.5% Hyperbaric Bupivacaine Based on a Dose Calculated ac | Group FD (fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated according to the patient's height 0.065 mg/cm Group FD (fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated according to the patient's height 0.065 mg/cm: Group FD (fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated according to the patient's height 0.065 mg/cm | 0 | 85 | 26 | 85 | 0 | 85 |
| EG002 | Group AD (Adjusted Dosage) Got Intrathecal Heavy Bupivacaine (0.5%) Tailored to the Patient's Height | Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight.: Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight. | 0 | 85 | 37 | 85 | 0 | 85 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypotension | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment | Blood pressure dropping below 90 beats per minute |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kudret Dogru | Erciyes University | +903522076666 | 24034 | kdogru@erciyes.edu.tr |
| Apr 1, 2026 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D014894 | Weights and Measures |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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