Failure Rate in Spinal Blocks and Determination of Related Factors

NCT03959644 | Completed

• 1 other identifier: Failure of Spinal Anesthesia
• Study Type: observational
• Target: 1,431
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Spinal

Keywords

unsuccessful spinal anesthesia

Outcome Measures

Primary Outcomes (4)

• Determination of Total Failure

  1\. Failure of localization of subarachnoid space with lumbar puncture and conversion from spinal anesthesia to general anesthesia

  During spinal punction procedure

• Determination of Total Failure

  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.

  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).

  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.

  From the spinal anesthetic injection to end of the surgery.

Secondary Outcomes (1)

• The first attempt success

  Before the spinal anesthetic injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \. Patients who are undergoing combined spinal-epidural anesthesia.

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

Bozyaka Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

Study Officials

• Aysun Afife Kar, Uz. Dr.

  Aysun Afife Kar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 22, 2019
• Study Start: May 10, 2019
• Primary Completion: May 10, 2020
• Study Completion: May 10, 2020
• Last Updated: October 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)