Thoraco Lumbar Vertebral Length and Bupivacaine Dosage in C-Section
NCT ID: NCT06869434
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
285 participants
INTERVENTIONAL
2025-05-20
2025-12-15
Brief Summary
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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).
Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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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
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
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.
Interventions
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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
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 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Having regular antenatal visits
3. Singleton pregnancy at ≥37 weeks of gestation
4. Pregnant women aged 18-45 -
Exclusion Criteria
2. Undergoing an emergency cesarean section
3. Those with bleeding diathesis and those receiving anticoagulant therapy
4. With a history of carotid artery stenosis,
5. Cardiovascular disease,
6. Hypertension,
7. Chronic obstructive pulmonary disease,
8. Heart rhythm outside of sinus
9. Patients with a history of cerebrovascular disease
10. Alcoholism or psychiatric illness
11. Placenta previa, accreta, and percreta
18 Years
45 Years
FEMALE
Yes
Sponsors
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TC Erciyes University
OTHER
Responsible Party
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Kudret Dogru
Professor. Dr.
Principal Investigators
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Kudret Dogru, Prof. Dr.
Role: STUDY_DIRECTOR
TC Erciyes University
Locations
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Kudret Doğru
Kayseri, Melikgazi, Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
Related Links
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Related Info
Other Identifiers
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2025/62
Identifier Type: -
Identifier Source: org_study_id