Spinal Anesthesia EvaluationNCT07197398
Preoperative Data and the Spinal Spread of Local Anesthetic in Cesarean Section
An observational study of Spinal Anesthesia Evaluation and Cesarean Delivery, run by Centre of Postgraduate Medical Education at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Spinal Anesthesia Evaluation, Cesarean Delivery
- What is being tested?
- Spinal block level analysis, Data collection and Sub-group analysis
- How many people
- 183 participants
- Where
- 1 sitePoland
- Study dates
- 18 Sep 2025to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Cesarean delivery at term under spinal anesthesia
- American Society of Anesthesiologists (ASA) physical status <3
- BMI<40
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Centre of Postgraduate Medical Education,Department of Anesthesia and Intensive Care
Warsaw, 01-813
About this study
Official title: Preoperative Data and the Spinal Spread of Local Anesthetic in Cesarean Section - a Retrospective Analysis of High Hyperbaric Bupivacaine Dose Cases.
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.
Read the 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
- Being tested
- Spinal block level analysis, Data collection, Sub-group analysis
- Keywords
- spinal anesthesia, cesarean section, spinal dose, spinal block level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal block level analysisOther
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 collectionOther
Intervention is to retrieve and analyse anonymous perioperative data. After identification of eligible cases, statistical analysis will be performed
Sub-group analysisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Spinal block level analysis; Other: Data collection; Other: Sub-group analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Highest level of sensory block noted from the time of spinal injection until the end of surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start18 Sep 2025
- Primary completion30 Nov 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal Anesthesia EvaluationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre of Postgraduate Medical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bartosz Horosz, MD, Centre of Postgraduate Medical Education
- Investigators
- Małgorzata Malec-Milewska, MD, Prof., Study chair, Department of Anesthesia and Intensive Care, Orlowski Hospital, Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197398
- Sponsor's protocol ID
- 80/2025
- Status last verified
- May 2026
- First submitted
- 21 Sep 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25499016Bialowolska 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.
PubMed 33171677Wei 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.
PubMed 28834913
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Data and the Spinal Spread of Local Anesthetic in Cesarean Section - a Retrospective Analysis of High Hyperbaric Bupivacaine Dose Cases.
- ClinicalTrials.gov ID
- NCT07197398
- Acronym / sponsor ID
- 80/2025
- Conditions
- Spinal Anesthesia Evaluation, Cesarean Delivery
- Keywords
- spinal anesthesia, cesarean section, spinal dose, spinal block level
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Centre of Postgraduate Medical EducationUniversity, hospital or other
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parturients given spinal block with 12.5mg of hyperbaric bupivacaine | – | Other: Spinal block level analysis, Other: Data collection, Other: Sub-group analysisHospital'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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Cesarean delivery at term under spinal anesthesia
- American Society of Anesthesiologists (ASA) physical status <3
- BMI<40
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal block level analysisRelation 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 | Parturients given spinal block with 12.5mg of hyperbaric bupivacaine |
| Data collectionIntervention is to retrieve and analyse anonymous perioperative data. After identification of eligible cases, statistical analysis will be performed | Other | Parturients given spinal block with 12.5mg of hyperbaric bupivacaine |
| Sub-group analysisRelation 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. | Other | Parturients given spinal block with 12.5mg of hyperbaric bupivacaine |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Background: PubMed 25499016Ozkan 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.
- Background: PubMed 33171677Bialowolska 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.
- Background: PubMed 28834913Wei 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Małgorzata Malec-Milewska, MD, Prof. study chair
Department of Anesthesia and Intensive Care, Orlowski Hospital, Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Anesthesia Evaluation and Cesarean Delivery, run by Centre of Postgraduate Medical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07197398, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.