Factors Associated With Failed Spinal Anesthesia for Cesarean Delivery

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

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 Overview

• Status: Completed
• Conditions: Cesarean Section Complications; Anesthesia; Adverse Effect
• Intervention / Treatment: Procedure: spinal anaesthesia with local anaesthetic and intrathecal morphine

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 Type: Observational
• Enrollment (Actual): 440

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Anesthesiology department, Siriraj hospital, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Failed spinal anaesthesia group; Failed spinal anaesthesia: failure of anaesthetic level of blockade both sensory and motor blockage, and consequently receive general anaesthesia	Procedure: spinal anaesthesia with local anaesthetic and intrathecal morphine; Patients undergoing cesarean delivery and received spinal anaesthesia with local anaesthetic and intrathecal morphine
Control Group; Patient receiving spinal anaesthesia and successfully finish the cesarean section	Procedure: spinal anaesthesia with local anaesthetic and intrathecal morphine; Patients undergoing cesarean delivery and received spinal anaesthesia with local anaesthetic and intrathecal morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Factors involving failed spinal anaesthesia for cesarean delivery: patient age	At starting operation
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
Anaesthesiologist performing spinal anaesthesia	Factors involving failed spinal anaesthesia for cesarean delivery: Anaesthesiologist performing spinal anaesthesia (resident or consultant)	At starting anaesthesia
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of failed spinal anaesthesia for cesarean delivery	Incidence of failed spinal anaesthesia for cesarean delivery	At starting operation

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Patchareya Nivatpumin, M.D., Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, THAILAND

Publications and helpful links

General Publications

• Wolwer W, Frommann N, Lowe A, Kamp D, Weide K, Bechdolf A, Brockhaus-Dumke A, Hurlemann R, Muthesius A, Klingberg S, Hellmich M, Schmied S, Meyer-Lindenberg A; ISST study group. Efficacy of Integrated Social Cognitive Remediation vs. Neurocognitive Remediation in Improving Functional Outcome in Schizophrenia: Concept and Design of a Multicenter, Single-Blind RCT (The ISST Study). Front Psychiatry. 2022 Jun 21;13:909370. doi: 10.3389/fpsyt.2022.909370. eCollection 2022.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2020
• Primary Completion (Actual): February 15, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: December 14, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: cesarean section; Spinal anaesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Anesthetics; Anesthetics, Local; Morphine
• Other Study ID Numbers: 290/2563 (EC1); 445/2020 (Other Identifier: Siriraj Institutional Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The plan to make individual participant data (IPD) available to other researchers was undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No