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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
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07197398
Enrollment
183
Registered
2025-09-29
Start date
2025-09-18
Completion date
2025-12-30
Last updated
2026-06-01

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

Conditions

Cesarean Delivery, Spinal Anesthesia Evaluation

Keywords

spinal anesthesia, cesarean section, spinal dose, spinal block level

Brief 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)).

Interventions

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.

OTHERData collection

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

OTHERSub-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.

Sponsors

Centre of Postgraduate Medical Education
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessed variable - block level correlation coefficientHighest level of sensory block noted from the time of spinal injection until the end of surgical procedureRegression 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.

Countries

Poland

Contacts

STUDY_CHAIRMałgorzata Malec-Milewska, MD, Prof.

Department of Anesthesia and Intensive Care, Orlowski Hospital, Warsaw

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 2, 2026