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Ultrasound for Neuraxial Anesthesia

Not Applicable
Completed
Conditions
Lumbar Ultrasound
Interventions
Device: Detection of the puncture site by ultrasound scan of the lumbar spine.
Procedure: Detection of the puncture site by identification of the landmarks.
Registration Number
NCT02553746
Lead Sponsor
424 General Military Hospital
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
146
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
UltrasoundDetection of the puncture site by ultrasound scan of the lumbar spine.-
LandmarksDetection of the puncture site by identification of the landmarks.-
Primary Outcome Measures
NameTimeMethod
Number of Participants With Successful TechniquesAn expected average of 10 minutes after the technique.

For spinal and epidural anesthesia, success of the technique is defined as the installation of sensory block before surgery. For epidural catheter placement success of the technique is defined as the installation of sensory block after the end of surgery.

Repositioning Frequency.An expected average of 10 minutes after the technique.

How many times did the operator change the trajectory of the needle.

Number of Participants With Change of the Intervertebral Space.An expected average of 10 minutes after the technique.

Number of patients to whom the operator had to perform the puncture at a different intervertebral place than the initial one.

Number of Participants With Success of the Technique at the First AttemptAn expected average of 10 minutes after the technique.

Number of patients with completion of the technique without any withdrawal or reposition of the needle.

Number of Attempts Required.An expected average of 10 minutes after the technique..

How many times did the operator withdraw the needle and repeated the puncture.

Time Required.An expected average of 15 minutes.

Time passed from the positioning of the patient on the table until the end of the neuraxial anesthesia

Secondary Outcome Measures
NameTimeMethod
Depth of the Epidural Space Measured by Ultrasound.An expected average of 3 minutes after the beginning of the procedure.

The distance between the skin and the ligamentum flavum measured by the built-in ultrasound caliper.

Low Back Pain Intensity.12hours and 24hours after the end of the technique.

The patient is asked to evaluate the lumbar pain by the 11scale Numerical Rating Scale (0 no pain, 10 maximum possible pain).

Number of Patients With Low Back Pain.12hours and 24hours after the end of the technique.

Number of patients who reported low back pain after the technique.

Depth of the Epidural Space Measured by the Needle.An expected average of 5 minutes after the beginning of the procedure.

The distance between the skin and the ligamentum flavum measured by the markers on the Tuohy needle.

Patient Satisfaction.12hours after the end of the technique.

The patient is asked if he is satisfied with the technique (Definitely not, Not completely, Yes) and if he would choose the same technique in the future (Yes/No).

Number of Participants With Any Complication.24hours after the end of the technique.

Number of patients who had any complication after the technique

Trial Locations

Locations (1)

424 Army General Hospital Department of Anesthesia

🇬🇷

Thessaloniki, Greece

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