Anesthesia, SpinalNCT03959644
Failure Rate in Spinal Blocks and Determination of Related Factors
An observational study of Anesthesia, Spinal, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Investigators aimed to determine the rates of unsuccessful spinal anesthesia, to determine the factors related to failure and to determine the measures that may be taken to reduce this problem. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Spinal
- How many people
- 1,431 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2019to 10 May 2020
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients aged ≥ 18 years undergoing spinal anesthesia in the Izmir Bozyaka Training and Research Hospital Operating Room will be included in the study.
Who may be able to join
- Patients aged ≥ 18 years who are undergoing spinal anesthesia in Izmir Bozyaka Training and Research Hospital during study period.
- American Society of Anesthesiologist Physical Status classification (ASA) I-IV.
Who cannot join
- 1. Patients who are undergoing combined spinal-epidural anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Failure Rate in Spinal Blocks and Determination of Related Factors: A Cross-Sectional, Prospective, Observational Study
Investigators aimed to determine the rates of unsuccessful spinal anesthesia, to determine the factors related to failure and to determine the measures that may be taken to reduce this problem.
Read the detailed description
The study is as a cross-sectional, prospective, observational. After institutional review board approval and informed written consent, all patients aged ≥ 18 years undergoing spinal anesthesia in the Izmir Bozyaka Training and Research Hospital Operating Room will be included in the study. The specialist and assistant physician in charge of spinal anesthesia management of patients will undertake their own routine anesthesia management and the researcher will not be involved in any way. Patients who underwent combined spinal-epidural anesthesia and patients without consent were excluded. The primary aim of the study was to determine the rate of unsuccessful spinal anesthesia (total failure and partial failure) and to determine the factors that may be associated with these. Total failure was described as failure of localization of subarachnoid space with lumbar puncture; no motor and / or sensory block occurring within 10 minutes after the injection of local anesthetic into the subarachnoid space; repeated spinal anesthesia or general anesthesia. Partial failure was described as the need for anesthetic agents such as ketamine, propofol or opioid for the intraoperative pain relief, except for the use of midazolam and fentanyl in order to increase the patient's comfort.The secondary aim of the study was to determine the first attempt success and related factors. The first attempt success was described as identification or subarachnoid space at the first attempt.
Parameters to be recorded during the study are: age, gender, weight, height, body mass index (BMI), American Society of Anesthesiologist (ASA) status, type of surgery, elective / emergency surgery, patient's body type, spinal anatomy, position of the patient and the practitioner during spinal intervention, the technique applied (median /paramedian), the level of puncture, the type of spinal needle, the direction of the spinal needle notch, the number of spinal puncture, the nature of the cerebrospinal fluid (CSF) (clear/haemorrhagic), whether or not aspiration is performed, whether or not free CSF is controlled before or after drug injection, whether the practitioner is an expert or assistant, the assistant is seniority year, the type of local anesthetic, if the adjuvant drug is added to the local anesthetic, the dose of anesthetic, the loss of drug during injection of local anesthesia, position of the patient after injection, duration of surgery, testing of motor and sensory block, what is done in case of unsuccessful spinal anesthesia, examination of sacral dermatomes prior to second spinal anesthesia intervention will be recorded. Parameters will be recorded by Anesthesia Specialist, Anesthesia Assistant or Anesthesia Technician. At the end of the case, the registration form will be left at the designated place in the Anesthesia Clinic room.
- Conditions
- Anesthesia, Spinal
- Keywords
- unsuccessful spinal anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Total Failure
- Failure of localization of subarachnoid space with lumbar puncture and conversion from spinal anesthesia to general anesthesia
Measured: During spinal punction procedure
Determination of Total Failure
- No motor block (Bromage Scale = 0) occurring within 10 minutes after the injection of local anesthetic into the subarachnoid space and performing spinal anesthesia for the second time or conversion from spinal anesthesia to general anesthesia.
Motor block will be determined by Bromage scale. Bromage Scale: 0 = ability to lift an extended knee at the hip; 1 = ability to flex the knee but not to lift an extended leg; 2 = ability to flex toes only; 3 = inability to move.
Measured: At 10 min after spinal anesthetic injection
Determination of Total Failure
No sensory block (Pinprick Test = 0) occurring within 10 minutes after the injection of local anesthetic into the subarachnoid space and performing spinal anesthesia for the second time or conversion from spinal anesthesia to general anesthesia.
Sensory block will be determined by Pinprick test. Pinprick Test: Sensory 0 = an ability to appreciate a pinprick as sharp; 1 = perception of a pinprick as less sharp than in unblocked areas; 2 = perception of a pinprick as touch but not sharp (analgesia); 3 = an inability to feel pinprick (anesthesia).
Measured: At 10 min after spinal anesthetic injection
Determination of Partial Failure
After complete spinal anesthesia, the need for intravenous anesthetic agents such as ketamine, propofol, opioid or general anesthesia in the intraoperative period for pain relief when a patient complained of moderate to severe pain or had a Visual Analogue Scale (VAS) of > 3 out of 10 from the surgical site.
Visual Analogue Scale (VAS): 0 = No pain - 10 = Worst imaginable pain.
Measured: From the spinal anesthetic injection to end of the surgery.
Secondary outcomes (1)
The first attempt success
Identification of subarachnoid space at first spinal puncture.
Measured: Before the spinal anesthetic injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start10 May 2019
- Primary completion10 May 2020
- Study completion10 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, SpinalStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,431 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Afife Aysun Kar, Bozyaka Training and Research Hospital
- Investigators
- Aysun Afife Kar, Uz. Dr., Principal investigator, Aysun Afife Kar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959644
- Sponsor's protocol ID
- Failure of Spinal Anesthesia
- Status last verified
- Oct 2022
- First submitted
- 16 May 2019
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Failure Rate in Spinal Blocks and Determination of Related Factors: A Cross-Sectional, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT03959644
- Acronym / sponsor ID
- Failure of Spinal Anesthesia
- Conditions
- Anesthesia, Spinal
- Keywords
- unsuccessful spinal anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,431 participants (actual)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 10 May 2020 (actual)
- First posted
- 22 May 2019 (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.
Investigators aimed to determine the rates of unsuccessful spinal anesthesia, to determine the factors related to failure and to determine the measures that may be taken to reduce this problem.
Detailed description
The study is as a cross-sectional, prospective, observational. After institutional review board approval and informed written consent, all patients aged ≥ 18 years undergoing spinal anesthesia in the Izmir Bozyaka Training and Research Hospital Operating Room will be included in the study. The specialist and assistant physician in charge of spinal anesthesia management of patients will undertake their own routine anesthesia management and the researcher will not be involved in any way. Patients who underwent combined spinal-epidural anesthesia and patients without consent were excluded. The primary aim of the study was to determine the rate of unsuccessful spinal anesthesia (total failure and partial failure) and to determine the factors that may be associated with these. Total failure was described as failure of localization of subarachnoid space with lumbar puncture; no motor and / or sensory block occurring within 10 minutes after the injection of local anesthetic into the subarachnoid space; repeated spinal anesthesia or general anesthesia. Partial failure was described as the need for anesthetic agents such as ketamine, propofol or opioid for the intraoperative pain relief, except for the use of midazolam and fentanyl in order to increase the patient's comfort.The secondary aim of the study was to determine the first attempt success and related factors. The first attempt success was described as identification or subarachnoid space at the first attempt.
Parameters to be recorded during the study are: age, gender, weight, height, body mass index (BMI), American Society of Anesthesiologist (ASA) status, type of surgery, elective / emergency surgery, patient's body type, spinal anatomy, position of the patient and the practitioner during spinal intervention, the technique applied (median /paramedian), the level of puncture, the type of spinal needle, the direction of the spinal needle notch, the number of spinal puncture, the nature of the cerebrospinal fluid (CSF) (clear/haemorrhagic), whether or not aspiration is performed, whether or not free CSF is controlled before or after drug injection, whether the practitioner is an expert or assistant, the assistant is seniority year, the type of local anesthetic, if the adjuvant drug is added to the local anesthetic, the dose of anesthetic, the loss of drug during injection of local anesthesia, position of the patient after injection, duration of surgery, testing of motor and sensory block, what is done in case of unsuccessful spinal anesthesia, examination of sacral dermatomes prior to second spinal anesthesia intervention will be recorded. Parameters will be recorded by Anesthesia Specialist, Anesthesia Assistant or Anesthesia Technician. At the end of the case, the registration form will be left at the designated place in the Anesthesia Clinic room.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients aged ≥ 18 years undergoing spinal anesthesia in the Izmir Bozyaka Training and Research Hospital Operating Room will be included in the study.
Key inclusion criteria (2 listed)
- Patients aged ≥ 18 years who are undergoing spinal anesthesia in Izmir Bozyaka Training and Research Hospital during study period.
- American Society of Anesthesiologist Physical Status classification (ASA) I-IV.
Key exclusion criteria (1 listed)
- 1. Patients who are undergoing combined spinal-epidural anesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determination of Total Failure
Time frame: During spinal punction procedure
1. Failure of localization of subarachnoid space with lumbar puncture and conversion from spinal anesthesia to general anesthesia
Determination of Total Failure
Time frame: At 10 min after spinal anesthetic injection
2. No motor block (Bromage Scale = 0) occurring within 10 minutes after the injection of local anesthetic into the subarachnoid space and performing spinal anesthesia for the second time or conversion from spinal anesthesia to general anesthesia. Motor block will be determined by Bromage scale. Bromage Scale: 0 = ability to lift an extended knee at the hip; 1 = ability to flex the knee but not to lift an extended leg; 2 = ability to flex toes only; 3 = inability to move.
Determination of Total Failure
Time frame: At 10 min after spinal anesthetic injection
No sensory block (Pinprick Test = 0) occurring within 10 minutes after the injection of local anesthetic into the subarachnoid space and performing spinal anesthesia for the second time or conversion from spinal anesthesia to general anesthesia. Sensory block will be determined by Pinprick test. Pinprick Test: Sensory 0 = an ability to appreciate a pinprick as sharp; 1 = perception of a pinprick as less sharp than in unblocked areas; 2 = perception of a pinprick as touch but not sharp (analgesia); 3 = an inability to feel pinprick (anesthesia).
Determination of Partial Failure
Time frame: From the spinal anesthetic injection to end of the surgery.
After complete spinal anesthesia, the need for intravenous anesthetic agents such as ketamine, propofol, opioid or general anesthesia in the intraoperative period for pain relief when a patient complained of moderate to severe pain or had a Visual Analogue Scale (VAS) of > 3 out of 10 from the surgical site. Visual Analogue Scale (VAS): 0 = No pain - 10 = Worst imaginable pain.
1 secondary outcome
The first attempt success
Time frame: Before the spinal anesthetic injection
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 25 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Aysun Afife Kar, Uz. Dr. principal investigator
Aysun Afife Kar
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, Spinal, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 1 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 25 Oct 2022. 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 Turkey (Türkiye). 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?
Determination of Total Failure (time frame: During spinal punction procedure). 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?
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 25 Oct 2022.