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Completed

NCT Number: NCT07197398

Preoperative Data and the Spinal Spread of Local Anesthetic in Cesarean Section

This study is designed to assess possible relation between the anthropometric data of pregnant women at term, as well as their babies, and the maximal level of sensory blockade following spinal anesthesia for cesarean section. The debate regarding this relation is ongoing. Although there is some relevant data in favor of both lack and the presence of significant relation between these variables, it is still not clear whether the same dose of local anesthetic is similarly effective, regardless of parturient's and fetal size.

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Key information

Conditions

Spinal Anesthesia Evaluation Cesarean Delivery

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre of Postgraduate Medical Education,Department of Anesthesia and Intensive Care

Warsaw, 01-813, Poland

About this study

Spinal block is a gold standard of cesarean section anesthesia. Two major factors contribute to its popularity: more than satisfactory level of surgical conditions and the fact that the mother is able to witness the birth of her child and both of them can benefit from skin-to-skin contact. For the procedure to proceed with patient's comfort the level of sensory block is required to be adequately high, reaching high thoracic dermatomes.

For this reason the quest for the ideal dose of local anesthetic is still ongoing. A few strategies has been proposed. Adjusting the dose to patient's size is probably the most popular. In order to minimize the risk of spinal block - related complications and maintain acceptable level of effectiveness, it was suggested that height, weight, maternal weight gain, abdominal circumference or combination of these variables may be used to calculate the appropriate spinal dose of hyperbaric bupivacaine.

In this study we will investigate whether demographic variables relate to maximal level of spinal sensory blockade when the same high dose of local anesthetic is used (close to the dose effective in 95% of cases (ED95)).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cesarean delivery at term under spinal anesthesia
  • American Society of Anesthesiologists (ASA) physical status <3
  • BMI<40

Exclusion criteria

  • Spinal anesthesia with the dose different than 12.5mg of hyperbaric bupivacaine
  • Local anesthetic other than hyperbaric bupivacaine used
  • Failed spinal anesthesia
  • Poor quality of anesthetic record - required data not available

Treatment and study plan

Spinal block level analysis

Other

Relation of pregnancy - related, maternal and neonatal data to the level of sensory blockade in the whole study group will be assessed. Only cases with 12.5mg of hyperbaric bupivacaine will be included.

Data Collection

Other

Intervention is to retrieve and analyse anonymous perioperative data. After identification of eligible cases, statistical analysis will be performed

Sub-group analysis

Other

Relation of pregnancy - related, maternal and neonatal data to the level of sensory blockade in the sub-groups of different height (<165cm and >165cm) will also be performed.

Primary outcomes

  1. Assessed variable - block level correlation coefficient

    Time frame: Highest level of sensory block noted from the time of spinal injection until the end of surgical procedure

    Regression and correlation analysis will be employed to assess the relation between pregnancy-related, maternal and neonatal data and the level of sensory block. For the purpose of statistical analysis the level of block will be converted into numbers for more reliable outcome.

Sponsors and collaborators

Lead sponsor

Centre of Postgraduate Medical Education

Other

Registry information

Official study title

Preoperative Data and the Spinal Spread of Local Anesthetic in Cesarean Section - a Retrospective Analysis of High Hyperbaric Bupivacaine Dose Cases.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 29, 2025
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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