NCT07197398

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 140 (estimated)
• Sponsor: Centre of Postgraduate Medical Education · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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)).

Conditions

• Spinal Anesthesia Evaluation
• Cesarean Delivery

Interventions

Type	Name	Description
OTHER	Spinal block level analysis	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.
OTHER	Data collection	Intervention is to retrieve and analyse anonymous perioperative data. After identification of eligible cases, statistical analysis will be performed
OTHER	Sub-group analysis	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.

Timeline

• Start date: 2025-09-18
• Primary completion: 2025-11-30
• Completion: 2025-11-30
• First posted: 2025-09-29
• Last updated: 2025-09-29

Locations

1 site across 1 country: Poland