Thoraco Lumbar Vertebral Length and Bupivacaine Dosage in C-Section

NCT06869434 | Completed Results

• 1 other identifier: 2025/62
• Study Type: interventional
• Target: 446
• Locations: 1 country
• Sites: 1

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).

Conditions

Obstetric Anesthesia Problems; Bupivacaine Adverse Reaction

Keywords

Vertebral length, bupivacaine, cesarean,spinal, hypotension

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

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

Procedure: Group VBL (Thoracolumbal 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

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

ACTIVE COMPARATOR

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.

Interventions

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 FD (fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated ac

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

Also known as: 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 VBL (Vertebral body length) received 0.2 mg x VBL cm of %0.5 hyperbaric bupivacaine,

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.

Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Kudret Doğru

Kayseri, Melikgazi, 38050, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 27066205 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.

  PMID: 29090733 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.

  PMID: 33456918 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.

  PMID: 1599111 BACKGROUND

Related Links

• National Library Medicine
• National Library Medicine

MeSH Terms

Conditions

Hypotension

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Kudret Dogru
• Organization: Erciyes University

kdogru@erciyes.edu.tr

+903522076666

Study Officials

• Kudret Dogru, Prof. Dr.

  TC Erciyes University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor. Dr.

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 11, 2025
• Study Start: May 20, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 15, 2025
• Last Updated: April 24, 2026
• Results First Posted: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)