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Abstract
Introduction Effectively preventing or treating spinal-induced maternal hypotension is considered to be the Holy Grail of obstetric anaesthesia. Prophylactic fluid preloading and vasopressors decrease hypotension but may aggravate heart load, induce fetal acidosis or maternal bradycardia. Using low-dose local anaesthetic decreases hypotension but may cause insufficient anaesthesia. Whether there is a height-based dosing algorithm of local anaesthetic in spinal anaesthesia for caesarean section that can provide sufficient anaesthesia with less hypotension without prophylactic fluid preloading and vasopressors is unclear. This study was designed to investigate a height-based dosing algorithm of bupivacaine in spinal anaesthesia for caesarean section.
Methods and analysis This single-centre, double-blinded, prospective, non-inferiority, randomised controlled trial will include 264 parturients (between 18 and 45 years of age) who are scheduled for caesarean section. All participants will not receive prophylactic fluid preloading. The participants will be randomly divided into two groups: the test group or conventional group. For parturients in the test group, 0.5% isobaric bupivacaine (1.15–1.70 mL) will be injected into the subarachnoid space without prophylactic vasopressors. The bupivacaine dose depends on the height of subjects. For parturients in the conventional group, 0.5% bupivacaine (1.8 mL) will be injected into the subarachnoid space along with prophylactic vasopressors. The primary outcome is the incidence of maternal hypotension. The secondary outcomes include the failure rate of spinal anaesthesia, level of sensory block, degree of motor block, other complications in parturients, time of operation, neonatal outcome and quality of anaesthesia.
Ethics and dissemination This study was approved by the Ethics Committee of Shenzhen People’s Hospital of Jinan University (Permit No. SZY-00251, chairperson Xiaofang Yu) on 8 February 2018The study results will be disseminated through peer-reviewed journals, professional societies and meetings.
Trial registration number NCT03497364; Pre-results.
- cesarean section
- spinal anesthesia
- hypotension
- prophylactic fluid pre-loading
- prophylactic vasopressors
- bupivacaine
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Footnotes
Contributors ZZ and BH conceived and designed the experiments. BH, QH, CH and ZZ performed the experiments. QH and YL analysed the data. CH contributed reagents/materials/analysis tools. BH wrote the paper.
Funding This work was supported by grants from the Doctoral Innovation Program of Health and Family Planning Commission of Shenzhen Municipality of China (SZBC2017016) to BH.
Disclaimer The sponsors have no role in the study design and conduct; the collection, management, analysis and interpretation of the data; or the preparation and approval of the manuscript.
Competing interests None declared.
Ethics approval This study was approved by the Ethics Committee of Shenzhen People’s Hospital of Jinan University (Permit No. SZY-00251, chairperson Xiaofang Yu) on 8 February 2018.
Provenance and peer review Not commissioned; externally peer reviewed.