Ultrasound for Neuraxial Anesthesia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02553746
• Date of registration: 15/09/2015
• Prospective Registration: No
• Primary sponsor: 424 General Military Hospital
• Public title: Ultrasound for Neuraxial Anesthesia
• Scientific title: Study of the Use of Ultrasound Scan for Lumbar Regional Anesthesia
• Date of first enrolment: September 2015
• Target sample size: 146
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02553746
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Greece

Contacts

• Name: Georgios Kotsovolis
• Affiliation: 424 Army General Hospital of Thessaloniki

Key inclusion & exclusion criteria

Inclusion Criteria:

- Surgery under spinal, epidural or combined spinal-epidural anesthesia.

- Surgery under general anesthesia and preoperative placement of epidural catheter for
postoperative analgesia.

- ASA 1-3.

Exclusion Criteria:

- History of lumbar spinal surgery.

- Low back pain at the time of anesthesia



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lumbar Ultrasound

Intervention(s)

Device: Detection of the puncture site by ultrasound scan of the lumbar spine.

Procedure: Detection of the puncture site by identification of the landmarks.

Primary Outcome(s)

Time Required. [Time Frame: An expected average of 15 minutes.]

Number of Attempts Required. [Time Frame: An expected average of 10 minutes after the technique..]

Number of Participants With Success of the Technique at the First Attempt [Time Frame: An expected average of 10 minutes after the technique.]

Number of Participants With Change of the Intervertebral Space. [Time Frame: An expected average of 10 minutes after the technique.]

Number of Participants With Successful Techniques [Time Frame: An expected average of 10 minutes after the technique.]

Repositioning Frequency. [Time Frame: An expected average of 10 minutes after the technique.]

Secondary Outcome(s)

Depth of the Epidural Space Measured by the Needle. [Time Frame: An expected average of 5 minutes after the beginning of the procedure.]

Low Back Pain Intensity. [Time Frame: 12hours and 24hours after the end of the technique.]

Number of Participants With Any Complication. [Time Frame: 24hours after the end of the technique.]

Patient Satisfaction. [Time Frame: 12hours after the end of the technique.]

Depth of the Epidural Space Measured by Ultrasound. [Time Frame: An expected average of 3 minutes after the beginning of the procedure.]

Number of Patients With Low Back Pain. [Time Frame: 12hours and 24hours after the end of the technique.]

Secondary ID(s)

14073

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/08/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02553746