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

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.

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Key information

Conditions

Spinal Anesthesia Evaluation Cesarean Delivery

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

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

Warsaw, 01-355, Poland

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal block level analysis

Other

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 Collection

Other

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Centre of Postgraduate Medical Education

Other

Registry information

Official study 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.

Acronym: SpinDoBlock

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Dec 11, 2024
Registry last updated: Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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