Factors Associated With Failed Spinal Anesthesia for Cesarean Delivery

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04685980
• Other study ID #: 290/2563 (EC1)
• Secondary ID: 445/2020
• Status: Completed
• Start date: December 25, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: April 2023
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: August 31, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia; Adverse Effect
• Cesarean Section Complications

Intervention

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

Locations

Country	Name	City	State
Thailand	Anesthesiology department, Siriraj hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age	Factors involving failed spinal anaesthesia for cesarean delivery: patient age	At starting operation
Primary	Body mass index	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	At starting operation
Primary	Anaesthesiologist performing spinal anaesthesia	Factors involving failed spinal anaesthesia for cesarean delivery: Anaesthesiologist performing spinal anaesthesia (resident or consultant)	At starting anaesthesia
Primary	Time starting of 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	At starting operation
Secondary	Incidence of failed spinal anaesthesia for cesarean delivery	Incidence of failed spinal anaesthesia for cesarean delivery	At starting operation