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CompletedNCT04685980Updated Apr 11, 2023

Factors Associated With Failed Spinal Anesthesia for Cesarean Delivery

An observational study in Anesthesia; Adverse Effect and Cesarean Section Complications, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-11.

Sponsored by Mahidol University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
440
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

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Conditions studied

  • Anesthesia; Adverse Effect
  • Cesarean Section Complications

Keywords

  • Spinal anaesthesia
  • cesarean section
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In context

Lead sponsor

Mahidol University is the lead sponsor of 731 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Gestational age \< 24 weeks
  • Received combined spinal-epidural anaesthesia
  • Received peripheral nerve blockade
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
440 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Control Group

    Patient receiving spinal anaesthesia and successfully finish the cesarean section

    Procedure: spinal anaesthesia with local anaesthetic and intrathecal morphine

Interventions

  • Procedurespinal anaesthesia with local anaesthetic and intrathecal morphine

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

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What researchers measure

Primary outcomes

  1. Age

    Factors involving failed spinal anaesthesia for cesarean delivery: patient age

    Time frame: At starting operation

  2. 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

    Time frame: At starting operation

  3. Anaesthesiologist performing spinal anaesthesia

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

    Time frame: At starting anaesthesia

  4. 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

    Time frame: At starting operation

Secondary outcomes

  1. Incidence of failed spinal anaesthesia for cesarean delivery

    Incidence of failed spinal anaesthesia for cesarean delivery

    Time frame: At starting operation

07

Study locations

1 site
  • Anesthesiology department, Siriraj hospital, Mahidol University
    Bangkok, 10700, Thailand
08

References and documents

Publications

  • 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. PubMed 35801788 ↗

Individual participant data

Plan to share: Undecided — The plan to make individual participant data (IPD) available to other researchers was undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04685980
Lead sponsor
Mahidol University
Responsible party
Sponsor
First posted
Dec 28, 2020
Start date
Dec 25, 2020
Primary completion
Feb 15, 2021
Completion
Aug 31, 2021
Last update
Apr 11, 2023

Study contacts

Patchareya Nivatpumin, M.D.
principal investigator · Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, THAILAND

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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