Factors Associated With Failed Spinal Anesthesia for Cesarean Delivery

Completed

• Conditions: Cesarean Section Complications; Anesthesia; Adverse Effect
• Interventions: Procedure: spinal anaesthesia with local anaesthetic and intrathecal morphine

• Registration Number: NCT04685980
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study First Submitted: 2020-12-14
• Study First Submitted QC: 2020-12-22
• Study Start: 2020-12-25
• Study First Posted: 2020-12-28
• Primary Completion: 2021-02-15
• Study Completion: 2021-08-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 440

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Failed spinal anaesthesia group	spinal anaesthesia with local anaesthetic and intrathecal morphine	Failed spinal anaesthesia: failure of anaesthetic level of blockade both sensory and motor blockage, and consequently receive general anaesthesia
Control Group	spinal anaesthesia with local anaesthetic and intrathecal morphine	Patient receiving spinal anaesthesia and successfully finish the cesarean section

Primary Outcome Measures

Name	Time	Method
Anaesthesiologist performing spinal anaesthesia	At starting anaesthesia	Factors involving failed spinal anaesthesia for cesarean delivery: Anaesthesiologist performing spinal anaesthesia (resident or consultant)
Time starting of operation	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
Age	At starting operation	Factors involving failed spinal anaesthesia for cesarean delivery: patient age
Body mass index	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

Secondary Outcome Measures

Name	Time	Method
Incidence of failed spinal anaesthesia for cesarean delivery	At starting operation	Incidence of failed spinal anaesthesia for cesarean delivery

Trial Locations

Locations (1)

Anesthesiology department, Siriraj hospital, Mahidol University; 🇹🇭 Bangkok, Thailand