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

NCT07197398 | Completed

• 1 other identifier: 80/2025
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Anesthesia Evaluation; Cesarean Delivery

Keywords

spinal anesthesia; cesarean section; spinal dose; spinal block level

Outcome Measures

Primary Outcomes (1)

• Assessed variable - block level correlation coefficient

  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.

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

Study Arms (1)

Parturients given spinal block with 12.5mg of hyperbaric bupivacaine

Hospital's electronic database will be searched in order to identify elective cases of cesarean sections performed under spinal anesthesia. After that, a manual review of each case will follow and only those where the dose of hyperbaric bupivacaine used for spinal block was 12.5mg will be chosen for further analysis. Anesthetic records of these cases will be retrieved and assessed for its quality, clarity and completeness. During the process of further analysis an anonymized data will be retrieved and moved to Excel file: demographic and pregnancy - related data of the parturient, spinal block - related data (technique and dynamic of the sensory blockade, maternal hemodynamic parameters) and neonatal data (birthweight). Special attention will be paid to assure that all data is accessible only for investigators and remain anonymous throughout the analysis process.

Other: Spinal block level analysis; Other: Data collection; Other: Sub-group analysis

Interventions

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.

Parturients given spinal block with 12.5mg of hyperbaric bupivacaine

Data collection OTHER

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

Parturients given spinal block with 12.5mg of hyperbaric bupivacaine

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.

Parturients given spinal block with 12.5mg of hyperbaric bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population will be chosen from the cases of elective cesarean sections that took place in years 2017-2022 in Orlowski Hospital, Department of Obstetrics and Gynecology, Centre of Postgraduate Medical Education, Warsaw, Poland. Intention is to include at least 140 cases for good quality analysis

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre of Postgraduate Medical Education: lead

Study Sites (1)

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

Warsaw, 01-813, Poland

Location

Related Publications (3)

• Ozkan Seyhan T, Orhan-Sungur M, Basaran B, Savran Karadeniz M, Demircan F, Xu Z, Sessler DI. The effect of intra-abdominal pressure on sensory block level of single-shot spinal anesthesia for cesarean section: an observational study. Int J Obstet Anesth. 2015 Feb;24(1):35-40. doi: 10.1016/j.ijoa.2014.08.004. Epub 2014 Aug 27.

  PMID: 25499016 BACKGROUND

• Bialowolska K, Horosz B, Sekowska A, Malec-Milewska M. Fixed Dose versus Height-Adjusted Conventional Dose of Intrathecal Hyperbaric Bupivacaine for Caesarean Delivery: A Prospective, Double-Blinded Randomised Trial. J Clin Med. 2020 Nov 8;9(11):3600. doi: 10.3390/jcm9113600.

  PMID: 33171677 BACKGROUND

• Wei CN, Zhou QH, Wang LZ. Abdominal girth and vertebral column length aid in predicting intrathecal hyperbaric bupivacaine dose for elective cesarean section. Medicine (Baltimore). 2017 Aug;96(34):e7905. doi: 10.1097/MD.0000000000007905.

  PMID: 28834913 BACKGROUND

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Małgorzata Malec-Milewska, MD, Prof.

  Department of Anesthesia and Intensive Care, Orlowski Hospital, Warsaw

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 21, 2025
• First Posted: September 29, 2025
• Study Start: September 18, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

PL (1)