Dose-to-block Level Relation in Single Shot Spinal Anesthesia for Cesarean Section. (SpinDoBlock)

May 28, 2026 updated by: Bartosz Horosz, MD, Centre of Postgraduate Medical Education

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

362

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 01-355
        • Department of Anesthesiology and Intensive Care, Centre of Postgraduate Medical Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Spinal block level analysis
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.
Other: data collection
Intervention is to acquire and analyse anonymous perioperative data. After identification of the eligible cases, statistical analysis will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Highest level of sensory block noted from the time of spinal injection until the end of surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre of Postgraduate Medical Education

Investigators

  • Study Chair: Malgorzata Malec-Milewska, MD, Prof., Department of Anesthesia and Intensive Care, Orlowski Hospital, Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2024

Primary Completion (Actual)

February 27, 2026

Study Completion (Actual)

March 1, 2026

Study Registration Dates

First Submitted

December 1, 2024

First Submitted That Met QC Criteria

December 8, 2024

First Posted (Actual)

December 11, 2024

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 97/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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