N/A
N=446
Thoraco Lumbar Vertebral Length and Bupivacaine Dosage in C-Section
Obstetric Anesthesia Problems · Bupivacaine Adverse Reaction
Bottom Line
View on ClinicalTrials.gov: NCT06869434 ↗Enrolled (actual)
446
Serious AEs
28.2%
Results posted
Apr 2026
Primary outcome: Primary: Hypotension Rate Among the Groups — 9; 26; 37 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Group VBL (Thoracolumbal vertebral body length) received 0.2 mg x VBL cm of %0.5 hyperbaric bupivacaine (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 (Procedure); Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight. (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- TC Erciyes University
- Primary completion
- Dec 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hypotension Rate Among the Groups |
9; 26; 37 | — |
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).
Eligibility Criteria
Inclusion Criteria
- American Society of Anesthesiologists (ASA) Class II
- Having regular antenatal visits
- Singleton pregnancy at ≥37 weeks of gestation
- Pregnant women aged 18-45 -
Exclusion Criteria
- Those with eclampsia, those with preeclampsia
- Undergoing an emergency cesarean section
- Those with bleeding diathesis and those receiving anticoagulant therapy
- With a history of carotid artery stenosis,
- Cardiovascular disease,
- Hypertension,
- Chronic obstructive pulmonary disease,
- Heart rhythm outside of sinus
- Patients with a history of cerebrovascular disease
- Alcoholism or psychiatric illness
- Placenta previa, accreta, and percreta
Data sourced from ClinicalTrials.gov (NCT06869434). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.