Spinal Anesthesia EvaluationSpinDoBlockNCT06729567
Dose-to-block Level Relation in Single Shot Spinal Anesthesia for 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
The study is designed to support or deny relation between the dose of hyperbaric bupivacaine given intrathecally and extent of spinal block level. There is ongoing debate whether anesthetists should adjust the dose in the range of conventional doses in order to achieve appropriate coverage of anesthesia which would be… 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 and data collection
- How many people
- 362 participants
- Where
- 1 sitePoland
- Study dates
- 20 Nov 2024to 1 Mar 2026
- 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
- Adult, Older adult
Study population: Initial cohort for the study will be selected from the cases of cesarean section in years 2017 - 2022, who delivered in Orlowski Hospital, Department of Obstetrics and Gynaecology, Warsaw, Poland. Intention is to include at least 300 participants in the final analysis, to allow for regression 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 less than 9mg of hyperbaric bupivacaine
- Local anesthetic other than hyperbaric bupivacaine used
- Failed spinal anesthesia
- Poor quality of the anesthetic record - data required for analysis not available
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Anesthesiology and Intensive Care, Centre of Postgraduate Medical Education
Warsaw, 01-355
About this study
Official title: Number of Dermatomes Blocked by Conventional Dose Single Shot Spinal Anaesthesia for Cesarean Section May Not be Related to Hyperbaric Bupivacaine Dose - a Retrospective Analysis.
The study is designed to support or deny relation between the dose of hyperbaric bupivacaine given intrathecally and extent of spinal block level. There is ongoing debate whether anesthetists should adjust the dose in the range of conventional doses in order to achieve appropriate coverage of anesthesia which would be suitable for cesarean section.
Two strategies are predominantly used: low dose strategy, which is focused on safety, and conventional dose approach, which is more effective in terms of success of anesthesia, with markedly higher rate of spinal block - related complications. It is hypothesized that there may be no relation between block level and the dose if conventional doses are used. For that purpose anesthetic charts of cesarean sections will be reviewed to gather information on the doses of anesthetic used and the level of spinal block they produced.
Read the detailed description
Single - shot spinal block for cesarean delivery is a gold standard in obstetric anesthesia. Both level and density of the block may have direct impact on the quality of surgery, patient's comfort and the course of postoperative recovery. Ideal dose of local anaesthetic for single - shot spinal anesthesia is still to be decided, with ongoing debate on using either "low" or "conventional" doses as routine approach. Use of conventional doses of local anesthetic (doses nearing dose effective in 95 percent of patients,ED95) have proven to be superior to low dose regimens in terms of effectiveness and therefore this strategy is widely used, despite the higher risk of spinal block - related complications.
Amount of local anesthestic used is regarded to be a factor of significant influence on its intrathecal spread and the final level of block following single - shot spinal anesthesia. It was investigated in both general and obstetric populations, although most of the studies with results in favor of this relation were designed to assess the other factors, and the extend of sensory block was not set as their primary outcome.
It was previously reported that adjusting the conventional dose of hyperbaric bupivacaine to parturient's height does not change the risk of block failure and rate of complications when compared to fixed - dose regimen. Whether the change in bupivacaine dose within the range of conventional doses results in significant change in sensory block level is not clear.
This retrospective analysis was designed to assess the above relation
- Conditions
- Spinal Anesthesia Evaluation, Cesarean Delivery
- Being tested
- Spinal block level analysis, data collection
- Keywords
- spinal anesthesia, cesarean section, 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 the dose of hyperbaric bupivacaine to resulting spinal block level is to be assessed. Conventional dose cases (more than 9mg and less than 13mg) will be included in analysis.
data collectionOther
Intervention is to acquire and analyse anonymous perioperative data. After identification of the eligible cases, statistical analysis will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Parturients given spinal block with conventional dose of bupivacaine for cesarean delivery | Using electronic hospital database we will identify cases of cesarean section. Initially, all cases of cesarian delivery under spinal anesthesia will be identified. After that, manual review of the anesthetic charts will follow. Detailed data on anesthetic technique will be retrieved and cases where conventional dose of hyperbaric bupivacaine was used will be included in further analysis. Further review of the charts will provide demographic data of the parturients, data on vital signs during anesthesia and dynamic of sensory block level. Attention will be paid to assure that identification of the patient would not be possible with data used in this study. All identifiable data used in data retrieval process and analysis will be accessible only for investigators. Receives: Other: Spinal block level analysis; Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose - extent correlation coefficient
Pearson's and/or Spearman's correlation coefficient will be employed to asses relation between the dose and level of the sensory block. For the purpose of analysis the extent of the block will be expressed as a number of blocked dermatomes (S-5, L-5, T-12,C-8) for more reliable statistical analysis. Regression analysis will be performed if significant relation is found.
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 posted11 Dec 2024
- Study start20 Nov 2024
- Primary completion27 Feb 2026
- Study completion1 Mar 2026
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
- 362 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
- Malgorzata Malec-Milewska, MD, Prof., Study chair, Department of Anesthesia and Intensive Care, Orlowski Hospital, Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729567
- Sponsor's protocol ID
- 97/2024
- Acronym
- SpinDoBlock
- Status last verified
- Jul 2025
- First submitted
- 1 Dec 2024
- 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 25499016Visavakul O, Leurcharusmee P, Pipanmekaporn T, Khorana J, Patumanond J, Phinyo P. Effective Dose Range of Intrathecal Isobaric Bupivacaine to Achieve T5-T10 Sensory Block Heights for Elderly and Overweight Patients: An Observational Study. Medicina (Kaunas). 2023 Mar 1;59(3):484. doi: 10.3390/medicina59030484.
PubMed 36984485Huang YY, Chang KY. Sensory block level prediction of spinal anaesthesia with 0.5% hyperbaric bupivacaine: a retrospective study. Sci Rep. 2021 Apr 27;11(1):9105. doi: 10.1038/s41598-021-88726-2.
PubMed 33907264
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
- Number of Dermatomes Blocked by Conventional Dose Single Shot Spinal Anaesthesia for Cesarean Section May Not be Related to Hyperbaric Bupivacaine Dose - a Retrospective Analysis.
- ClinicalTrials.gov ID
- NCT06729567
- Acronym / sponsor ID
- SpinDoBlock / 97/2024
- Conditions
- Spinal Anesthesia Evaluation, Cesarean Delivery
- Keywords
- spinal anesthesia, cesarean section, spinal block level
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Centre of Postgraduate Medical EducationUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 11 Dec 2024 (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.
The study is designed to support or deny relation between the dose of hyperbaric bupivacaine given intrathecally and extent of spinal block level. There is ongoing debate whether anesthetists should adjust the dose in the range of conventional doses in order to achieve appropriate coverage of anesthesia which would be suitable for cesarean section.
Two strategies are predominantly used: low dose strategy, which is focused on safety, and conventional dose approach, which is more effective in terms of success of anesthesia, with markedly higher rate of spinal block - related complications. It is hypothesized that there may be no relation between block level and the dose if conventional doses are used. For that purpose anesthetic charts of cesarean sections will be reviewed to gather information on the doses of anesthetic used and the level of spinal block they produced.
Detailed description
Single - shot spinal block for cesarean delivery is a gold standard in obstetric anesthesia. Both level and density of the block may have direct impact on the quality of surgery, patient's comfort and the course of postoperative recovery. Ideal dose of local anaesthetic for single - shot spinal anesthesia is still to be decided, with ongoing debate on using either "low" or "conventional" doses as routine approach. Use of conventional doses of local anesthetic (doses nearing dose effective in 95 percent of patients,ED95) have proven to be superior to low dose regimens in terms of effectiveness and therefore this strategy is widely used, despite the higher risk of spinal block - related complications.
Amount of local anesthestic used is regarded to be a factor of significant influence on its intrathecal spread and the final level of block following single - shot spinal anesthesia. It was investigated in both general and obstetric populations, although most of the studies with results in favor of this relation were designed to assess the other factors, and the extend of sensory block was not set as their primary outcome.
It was previously reported that adjusting the conventional dose of hyperbaric bupivacaine to parturient's height does not change the risk of block failure and rate of complications when compared to fixed - dose regimen. Whether the change in bupivacaine dose within the range of conventional doses results in significant change in sensory block level is not clear.
This retrospective analysis was designed to assess the above relation
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parturients given spinal block with conventional dose of bupivacaine for cesarean delivery | – | Other: Spinal block level analysis, Other: data collectionUsing electronic hospital database we will identify cases of cesarean section. Initially, all cases of cesarian delivery under spinal anesthesia will be identified. After that, manual review of the anesthetic charts will follow. Detailed data on anesthetic technique will be retrieved and cases where conventional dose of hyperbaric bupivacaine was used will be included in further analysis. Further review of the charts will provide demographic data of the parturients, data on vital signs during anesthesia and dynamic of sensory block level. Attention will be paid to assure that identification of the patient would not be possible with data used in this study. All identifiable data used in data retrieval process and analysis will be accessible only for investigators. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Initial cohort for the study will be selected from the cases of cesarean section in years 2017 - 2022, who delivered in Orlowski Hospital, Department of Obstetrics and Gynaecology, Warsaw, Poland. Intention is to include at least 300 participants in the final analysis, to allow for regression 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 less than 9mg of hyperbaric bupivacaine
- Local anesthetic other than hyperbaric bupivacaine used
- Failed spinal anesthesia
- Poor quality of the anesthetic record - data required for analysis 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 the dose of hyperbaric bupivacaine to resulting spinal block level is to be assessed. Conventional dose cases (more than 9mg and less than 13mg) will be included in analysis. | Other | Parturients given spinal block with conventional dose of bupivacaine for cesarean delivery |
| data collectionIntervention is to acquire and analyse anonymous perioperative data. After identification of the eligible cases, statistical analysis will be performed. | Other | Parturients given spinal block with conventional dose of bupivacaine for cesarean delivery |
Primary outcome
Dose - extent correlation coefficient
Time frame: Highest level of sensory block noted from the time of spinal injection until the end of surgical procedure
Pearson's and/or Spearman's correlation coefficient will be employed to asses relation between the dose and level of the sensory block. For the purpose of analysis the extent of the block will be expressed as a number of blocked dermatomes (S-5, L-5, T-12,C-8) for more reliable statistical analysis. Regression analysis will be performed if significant relation is found.
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 36984485Visavakul O, Leurcharusmee P, Pipanmekaporn T, Khorana J, Patumanond J, Phinyo P. Effective Dose Range of Intrathecal Isobaric Bupivacaine to Achieve T5-T10 Sensory Block Heights for Elderly and Overweight Patients: An Observational Study. Medicina (Kaunas). 2023 Mar 1;59(3):484. doi: 10.3390/medicina59030484.
- Background: PubMed 33907264Huang YY, Chang KY. Sensory block level prediction of spinal anaesthesia with 0.5% hyperbaric bupivacaine: a retrospective study. Sci Rep. 2021 Apr 27;11(1):9105. doi: 10.1038/s41598-021-88726-2.
- 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.
Malgorzata 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?
Dose - extent 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 NCT06729567, 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.