Clinical trial NCT04685980: Factors Associated With Failed Spinal Anesthesia for Cesarean Delivery
Official title: Factors Associated With Failed Spinal Anesthesia for Cesarean Delivery, a Retrospective Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia; Adverse Effect
Cesarean Section Complications
Keywords: Spinal anaesthesia
cesarean section
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 440
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women who gestational age \> 24 weeks and patient age more than or equal to 18 years, undergoing cesarean delivery and received spinal anaesthesia.

Brief summary: The aim of this study is to reveal the factor associated with failed spinal anaesthesia in cesarean delivery. We conduct the retrospective case-control study to elucidate the involving factors.

Detailed description: Spinal anaesthesia is the anaesthetic technique of choice of patients undergoing cesarean delivery due to its rapid onset, good reliability and good efficacy. However, the inadequate or failed spinal anaesthesia can occur. The previous literatures revealed incidence of failed spinal anaesthesia was as high as 0.5-6%. Failure of spinal anaesthesia leads to numerous maternal and neonatal consequences. Those failed spinal anaesthesia patients required general anaesthesia with endotracheal tube which may cause several complications such as hypoxia, difficult intubation, failed intubation and pulmonary aspiration. Also, a recent network meta-analysis showed general anaesthesia decreasing neonatal Apgar score.

The factors that associated with failed spinal anaesthesia in cesarean delivery has been studied. The amount of local anaesthetic, needle type, patients' body mass index (obesity), and experiences of the anaesthetist performing spinal block influenced the failure of spinal anaesthesia. The details and factors of failed spinal anaesthesia in our hospital was scarce. It has not yet been published in the literature.

Therefore, the aim of this study is to reveal the factor associated with failed spinal anaesthesia in cesarean delivery. We conduct the retrospective case-control study to elucidate the involving factors.

Eligibility criteria: Inclusion Criteria:

* Age \>,= 18 years
* Undergoing cesarean delivery
* Failed spinal anaesthesia and received general anaesthesia with endotracheal tube

Exclusion Criteria:

* Gestational age \< 24 weeks
* Received combined spinal-epidural anaesthesia
* Received peripheral nerve blockade

Primary outcomes:
measure: Age
timeFrame: At starting operation
measure: Body mass index
timeFrame: At starting operation
measure: Anaesthesiologist performing spinal anaesthesia
timeFrame: At starting anaesthesia
measure: Time starting of operation
timeFrame: At starting operation
Secondary outcomes:
measure: Incidence of failed spinal anaesthesia for cesarean delivery
timeFrame: At starting operation
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Anesthesiology department, Siriraj hospital, Mahidol University
Study officials:
affiliation: Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, THAILAND
name: Patchareya Nivatpumin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Punchuklang W, Nivatpumin P, Jintadawong T. Total failure of spinal anesthesia for cesarean delivery, associated factors, and outcomes: A retrospective case-control study. Medicine (Baltimore). 2022 Jul 8;101(27):e29813. doi: 10.1097/MD.0000000000029813.