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Thoraco Lumbar Vertebral Length and Bupivacaine Dosage in C-Section

In Cesarean Sections, is the Length of the Thoracolumbar Vertebral Column Applicable for Determining the Dosage of Bupivacaine in Spinal Anesthesia?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06869434
Acronym
bupivacaine
Enrollment
446
Registered
2025-03-11
Start date
2025-05-20
Completion date
2025-12-15
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bupivacaine Adverse Reaction, Obstetric Anesthesia Problems

Keywords

Vertebral length, bupivacaine, cesarean,spinal, hypotension

Brief summary

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).

Detailed description

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

Interventions

PROCEDUREGroup 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

PROCEDUREGroup 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

PROCEDUREGroup 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.

Sponsors

TC Erciyes University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

1. American Society of Anesthesiologists (ASA) Class II 2. Having regular antenatal visits 3. Singleton pregnancy at ≥37 weeks of gestation 4. Pregnant women aged 18-45 -

Exclusion criteria

1. Those with eclampsia, those with preeclampsia 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

Design outcomes

Primary

MeasureTime frameDescription
Hypotension Rate Among the GroupsFrom initiation of spinal anesthesia to completion of surgery, during the intraoperative period (mean duration approximately 60-90 minutes)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.

Countries

Turkey (Türkiye)

Contacts

STUDY_DIRECTORKudret Dogru, Prof. Dr.

TC Erciyes University

Participant flow

Recruitment details

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

Pre-assignment details

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.

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
255 Participants
Age, Continuous29.8 yr
STANDARD_DEVIATION 6.15
Race/Ethnicity, Customized85 Participants
Region of Enrollment
Turkey
85 participants
Sex: Female, Male
Female
85 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 850 / 850 / 85
other
Total, other adverse events
0 / 850 / 850 / 85
serious
Total, serious adverse events
9 / 8526 / 8537 / 85

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026