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NCT Number: NCT04685980

Factors Associated With Failed Spinal Anesthesia for Cesarean Delivery

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.

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Key information

Conditions

Anesthesia; Adverse Effect Cesarean Section Complications

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Anesthesiology department, Siriraj hospital, Mahidol University

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

spinal anaesthesia with local anaesthetic and intrathecal morphine

Procedure

Patients undergoing cesarean delivery and received spinal anaesthesia with local anaesthetic and intrathecal morphine

Primary outcomes

  1. Age

    Time frame: At starting operation

    Factors involving failed spinal anaesthesia for cesarean delivery: patient age

  2. Body mass index

    Time frame: At starting operation

    Factors involving failed spinal anaesthesia for cesarean delivery: patient body mass index (BMI) : weight and height will be combined to report BMI in kg/m^2

  3. Anaesthesiologist performing spinal anaesthesia

    Time frame: At starting anaesthesia

    Factors involving failed spinal anaesthesia for cesarean delivery: Anaesthesiologist performing spinal anaesthesia (resident or consultant)

  4. Time starting of operation

    Time frame: At starting operation

    Factors involving failed spinal anaesthesia for cesarean delivery: at which time cesarean delivery starting to performed eg. in office hour or out of office hour

Secondary outcomes

  1. Incidence of failed spinal anaesthesia for cesarean delivery

    Time frame: At starting operation

    Incidence of failed spinal anaesthesia for cesarean delivery

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Factors Associated With Failed Spinal Anesthesia for Cesarean Delivery, a Retrospective Case-control Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 28, 2020
Registry last updated
Apr 11, 2023

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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