Clinical trial NCT02553746: Ultrasound for Neuraxial Anesthesia
Official title: Study of the Use of Ultrasound Scan for Lumbar Regional Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Ultrasound
Keywords: Ultrasound
Spinal anesthesia
Epidural anesthesia
Lead sponsor: 424 General Military Hospital
Sponsor class: OTHER
First posted: 2015-09-18
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The patients will be allocated to 2 groups: the ultrasound group and the palpation group. Ultrasound detection of the puncture site will be performed to the patients of the one group (group U). The puncture site will be determined by palpation of the landmarks at the patients of the other group (group L). The main purpose of the study is to determine if the ultrasound scan of the lumbar spine can facilitate spinal, epidural and combined spinal-epidural anesthesia, increase the success and decrease the complication rate of these techniques. The secondary purpose of the study is to evaluate if the lumbar ultrasound scan can be used to determine accurately the depth of the epidural space.


Eligibility 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

Primary outcomes:
measure: Number of Participants With Successful Techniques
timeFrame: An expected average of 10 minutes after the technique.
measure: Number of Participants With Success of the Technique at the First Attempt
timeFrame: An expected average of 10 minutes after the technique.
measure: Number of Attempts Required.
timeFrame: An expected average of 10 minutes after the technique..
measure: Repositioning Frequency.
timeFrame: An expected average of 10 minutes after the technique.
measure: Number of Participants With Change of the Intervertebral Space.
timeFrame: An expected average of 10 minutes after the technique.
measure: Time Required.
timeFrame: An expected average of 15 minutes.
Secondary outcomes:
measure: Depth of the Epidural Space Measured by Ultrasound.
timeFrame: An expected average of 3 minutes after the beginning of the procedure.
measure: Depth of the Epidural Space Measured by the Needle.
timeFrame: An expected average of 5 minutes after the beginning of the procedure.
measure: Number of Patients With Low Back Pain.
timeFrame: 12hours and 24hours after the end of the technique.
measure: Low Back Pain Intensity.
timeFrame: 12hours and 24hours after the end of the technique.
measure: Patient Satisfaction.
timeFrame: 12hours after the end of the technique.
measure: Number of Participants With Any Complication.
timeFrame: 24hours after the end of the technique.
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: 424 Army General Hospital Department of Anesthesia
Study officials:
affiliation: 424 Army General Hospital of Thessaloniki
name: Georgios Kotsovolis
role: PRINCIPAL_INVESTIGATOR
References:
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