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

NCT06729567 | Active Not Recruiting

• 1 other identifier: 97/2024
• Study Type: observational
• Target: 362
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Spinal Anesthesia Evaluation; Cesarean Delivery

Keywords

spinal anesthesia; cesarean section; spinal block level

Outcome Measures

Primary Outcomes (1)

• 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.

  Highest level of sensory block noted from the time of spinal injection until the end of surgical procedure

Study Arms (1)

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; Other: data collection

Interventions

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.

Parturients given spinal block with conventional dose of bupivacaine for cesarean delivery

data collection OTHER

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

Parturients given spinal block with conventional dose of bupivacaine for cesarean delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre of Postgraduate Medical Education: lead

Study Sites (1)

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

Warsaw, 01-355, Poland

Location

Related Publications (3)

• 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.

  PMID: 25499016 BACKGROUND

• Visavakul 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.

  PMID: 36984485 BACKGROUND

• Huang 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.

  PMID: 33907264 BACKGROUND

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Malgorzata Malec-Milewska, MD, Prof.

  Department of Anesthesia and Intensive Care, Orlowski Hospital, Warsaw

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 11, 2024
• Study Start: November 20, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

PL (1)