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Failure Rate in Spinal Blocks and Determination of Related Factors

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ClinicalTrials.gov Identifier: NCT03959644
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Afife Aysun Kar, Bozyaka Training and Research Hospital

Brief 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.

Condition or disease
Anesthesia, Spinal

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.


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Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Failure Rate in Spinal Blocks and Determination of Related Factors: A Cross-Sectional, Prospective, Observational Study
Actual Study Start Date : May 10, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020



Primary Outcome Measures :
  1. 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

  2. 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.


  3. 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).


  4. 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.



Secondary Outcome Measures :
  1. The first attempt success [ Time Frame: Before the spinal anesthetic injection ]
    Identification of subarachnoid space at first spinal puncture.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  1. Patients aged ≥ 18 years who are undergoing spinal anesthesia in Izmir Bozyaka Training and Research Hospital during study period.
  2. American Society of Anesthesiologist Physical Status classification (ASA) I-III.

Exclusion Criteria:

1. Patients who are undergoing combined spinal-epidural anesthesia.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959644


Contacts
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Contact: Aysun Afife Kar, Uz. Dr. +905326521313 aaysunkar@hotmail.com

Locations
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Turkey
Bozyaka Training and Research Hospital Recruiting
İzmir, Turkey
Sponsors and Collaborators
Bozyaka Training and Research Hospital
Investigators
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Principal Investigator: Aysun Afife Kar, Uz. Dr. Aysun Afife Kar

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Responsible Party: Afife Aysun Kar, Principal Investigator, Bozyaka Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03959644     History of Changes
Other Study ID Numbers: Failure of Spinal Anesthesia
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Afife Aysun Kar, Bozyaka Training and Research Hospital:
unsuccessful spinal anesthesia