Clinical trial NCT06729567: Dose-to-block Level Relation in Single Shot Spinal Anesthesia for Cesarean Section.
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.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Spinal Anesthesia Evaluation
Cesarean Delivery
Keywords: spinal anesthesia
cesarean section
spinal block level
Lead sponsor: Centre of Postgraduate Medical Education
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Dose - extent correlation coefficient
timeFrame: Highest level of sensory block noted from the time of spinal injection until the end of surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Warszawa
country: Poland
facility: Department of Anesthesiology and Intensive Care, Centre of Postgraduate Medical Education
Study officials:
affiliation: Department of Anesthesia and Intensive Care, Orlowski Hospital, Warsaw
name: Malgorzata Malec-Milewska, MD, Prof.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.