N/A
N=146
Ultrasound for Neuraxial Anesthesia
Lumbar Ultrasound
Bottom Line
View on ClinicalTrials.gov: NCT02553746 ↗Enrolled (actual)
146
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Number of Participants With Successful Techniques — 74; 63 Participants — p=0.748
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Detection of the puncture site by ultrasound scan of the lumbar spine. (Device); Detection of the puncture site by identification of the landmarks. (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- 424 General Military Hospital
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successful Techniques |
74; 63 | 0.748 |
| PRIMARY Number of Participants With Success of the Technique at the First Attempt |
48; 35 | 0.498 |
| PRIMARY Number of Attempts Required. |
1.65; 2.06 | 0.171 |
| PRIMARY Repositioning Frequency. |
0.74; 1.14 | 0.162 |
| PRIMARY Number of Participants With Change of the Intervertebral Space. |
14; 20 | 0.104 |
| PRIMARY Time Required. |
550.46; 451.94 | <0.005 sig |
| SECONDARY Depth of the Epidural Space Measured by Ultrasound. |
— | — |
| SECONDARY Depth of the Epidural Space Measured by the Needle. |
— | — |
| SECONDARY Number of Patients With Low Back Pain. |
11; 11 | — |
| SECONDARY Low Back Pain Intensity. |
— | — |
| SECONDARY Patient Satisfaction. |
74; 63; 3; 1; 0; 0 | — |
| SECONDARY Number of Participants With Any Complication. |
0; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT02553746). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.