Anesthesia; Adverse EffectNCT04685980
Factors Associated With Failed Spinal Anesthesia for Cesarean Delivery
An observational study of Anesthesia; Adverse Effect and Cesarean Section Complications, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anesthesia; Adverse Effect, Cesarean Section Complications
- What is being tested?
- spinal anaesthesia with local anaesthetic and intrathecal morphine
- Type of treatment
- Surgery or procedure
- How many people
- 440 participants
- Where
- 1 siteThailand
- Study dates
- 25 Dec 2020to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age >,= 18 years
- Undergoing cesarean delivery
- Failed spinal anaesthesia and received general anaesthesia with endotracheal tube
Who cannot join
- Gestational age < 24 weeks
- Received combined spinal-epidural anaesthesia
- Received peripheral nerve blockade
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Anesthesiology department, Siriraj hospital, Mahidol University
Bangkok, 10700
About this study
Official title: 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.
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.
- Being tested
- spinal anaesthesia with local anaesthetic and intrathecal morphine
- Keywords
- Spinal anaesthesia, cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anaesthesia with local anaesthetic and intrathecal morphineProcedure or surgery
Patients undergoing cesarean delivery and received spinal anaesthesia with local anaesthetic and intrathecal morphine
| Study group | Role | What they receive |
|---|---|---|
| Failed spinal anaesthesia group | Failed spinal anaesthesia: failure of anaesthetic level of blockade both sensory and motor blockage, and consequently receive general anaesthesia Receives: Procedure: spinal anaesthesia with local anaesthetic and intrathecal morphine | |
| Control Group | Patient receiving spinal anaesthesia and successfully finish the cesarean section Receives: Procedure: spinal anaesthesia with local anaesthetic and intrathecal morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
Factors involving failed spinal anaesthesia for cesarean delivery: patient age
Measured: 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
Measured: At starting operation
Anaesthesiologist performing spinal anaesthesia
Factors involving failed spinal anaesthesia for cesarean delivery: Anaesthesiologist performing spinal anaesthesia (resident or consultant)
Measured: 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
Measured: At starting operation
Secondary outcomes (1)
Incidence of failed spinal anaesthesia for cesarean delivery
Incidence of failed spinal anaesthesia for cesarean delivery
Measured: At starting operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start25 Dec 2020
- Primary completion15 Feb 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia; Adverse EffectStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patchareya Nivatpumin, M.D., Principal investigator, Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, THAILAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685980
- Sponsor's protocol ID
- 290/2563 (EC1)
- Other IDs
- 445/2020
- Status last verified
- Apr 2023
- First submitted
- 14 Dec 2020
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan to make individual participant data (IPD) available to other researchers was undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Failed Spinal Anesthesia for Cesarean Delivery, a Retrospective Case-control Study
- ClinicalTrials.gov ID
- NCT04685980
- Acronym / sponsor ID
- 290/2563 (EC1)
- Keywords
- Spinal anaesthesia, cesarean section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 25 Dec 2020 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Failed spinal anaesthesia group | – | Procedure: spinal anaesthesia with local anaesthetic and intrathecal morphineFailed spinal anaesthesia: failure of anaesthetic level of blockade both sensory and motor blockage, and consequently receive general anaesthesia |
| Control Group | – | Procedure: spinal anaesthesia with local anaesthetic and intrathecal morphinePatient receiving spinal anaesthesia and successfully finish the cesarean section |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age >,= 18 years
- Undergoing cesarean delivery
- Failed spinal anaesthesia and received general anaesthesia with endotracheal tube
Key exclusion criteria (3 listed)
- Gestational age < 24 weeks
- Received combined spinal-epidural anaesthesia
- Received peripheral nerve blockade
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal anaesthesia with local anaesthetic and intrathecal morphinePatients undergoing cesarean delivery and received spinal anaesthesia with local anaesthetic and intrathecal morphine | Procedure or surgery | Control Group, Failed spinal anaesthesia group |
Primary outcome
Age
Time frame: At starting operation
Factors involving failed spinal anaesthesia for cesarean delivery: patient age
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
Anaesthesiologist performing spinal anaesthesia
Time frame: At starting anaesthesia
Factors involving failed spinal anaesthesia for cesarean delivery: Anaesthesiologist performing spinal anaesthesia (resident or consultant)
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
1 secondary outcome
Incidence of failed spinal anaesthesia for cesarean delivery
Time frame: At starting operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Results publication: PubMed 35801788Punchuklang 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.
- Individual participant dataSharing planned: Undecided. The plan to make individual participant data (IPD) available to other researchers was undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patchareya Nivatpumin, M.D. principal investigator
Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, THAILAND
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia; Adverse Effect and Cesarean Section Complications, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age (time frame: At starting operation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04685980, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.