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

NCT ID: NCT07197398

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-18
• Study Completion Date: 2025-11-30

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)).

Conditions

Spinal Anesthesia Evaluation; Cesarean Delivery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Spinal block level analysis

Intervention Type: 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

Intervention Type: OTHER

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

Sub-group analysis

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Data collection

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre of Postgraduate Medical Education

OTHER

Sponsor Role: lead

Responsible Party

Bartosz Horosz, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Małgorzata Malec-Milewska, MD, Prof.

Role: STUDY_CHAIR

Department of Anesthesia and Intensive Care, Orlowski Hospital, Warsaw

Locations

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

Warsaw, , Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Bartosz Horosz, MD,PhD

Role: CONTACT

barhorosz@wp.pl

0048225841122

Facility Contacts

Bartosz Horosz, MD

Role: primary

0048225841122

References

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.

Reference Type: BACKGROUND

PMID: 25499016 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33171677 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28834913 (View on PubMed)

Other Identifiers

80/2025

Identifier Type: -

Identifier Source: org_study_id