Gel vs saline as medium for ultrasound-guided regional anesthesia
| ISRCTN | ISRCTN11124844 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11124844 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | HS#: 20-01288M |
| Sponsor | Mount Sinai Hospital |
| Funder | Investigator initiated and funded |
- Submission date
- 12/04/2021
- Registration date
- 27/04/2021
- Last edited
- 27/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The ultrasound-guided technique is the gold standard for procedural guidance in regional anesthesia. Traditionally, ultrasound gel has been used as the medium for ultrasound wave conduction, but the use of aqueous solutions such as D5W or normal saline has been described and kits containing gel or normal saline conducting mediums are commercially available. Ultrasound gel presents potential problems including a theoretical risk for nerve toxicity and cell damage, increased cost, allergic reaction, and difficultly in maintaining a static ultrasound probe position while performing a block; all of these factors are addressed when using normal saline. Previous studies evaluating the image quality for ultrasound-guided central line placement have shown that gel image quality is superior to normal saline, but both provided adequate views for placement of central lines. Regional anesthesia blocks often require more fine resolution to identify nerve structures, but no study to date has evaluated how normal saline compares to gel for ultrasound-guided regional anesthesia.
Who can participate?
Anesthesiology trainees and attending physicians within the Department of Anesthesiology, Perioperative & Pain Medicine at Mount Sinai
What does the study involve?
Anesthesiology trainees and attending physicians are asked to obtain a supraclavicular view (above the collarbone) with one medium before a washout period and then repeat the exercise with the other medium. The view with each medium is saved and two blinded experts grade each view as “proceed with the nerve block” or “not proceed with the nerve block”. If there is a disagreement between the two experts a third expert provides a tie-break.
What are the possible benefits and risks of participating?
Benefits include practising ultrasound skills and using different types of medium. The risk to participants is minimal. They risk others knowing they are participating in a research study. They may have stress associated with being observed while scanning with ultrasound. There is a risk of loss of study information including name, highest level of education, experience level with regional anesthesia, and time to obtaining scans/grade of ultrasound view.
Where is the study run from?
Mount Sinai Hospital (USA)
When is the study starting and how long is it expected to run for?
August 2020 to May 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Garrett Burnett
garrett.burnett@mountsinai.org
Contact information
Scientific
1468 Madison Avenue
New York
10029
United States of America
| Phone | +1 (0)9728970460 |
|---|---|
| garrett.burnett@mountsinai.org |
Public
1468 Madison Avenue
New York
10029
United States of America
| Phone | +1 (0)7329861514 |
|---|---|
| Amar.bhavsar@mountsinai.org |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomized simulation study with crossover component |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| Scientific title | Ultrasound gel vs sterile saline as conducting medium for ultrasound-guided regional anesthesia |
| Study objectives | Gel would provide superior images for ultrasound-guided regional anesthesia compared to normal saline. |
| Ethics approval(s) | Approved 10/21/2020, Institutional Review Board of the Mount Sinai School of Medicine (One Gustave L. Levy Place Box 1621 New York, NY 10029, USA; +1 (0)212 824 8200; irb@mssm.edu), ref: HS#: 20-01288M |
| Health condition(s) or problem(s) studied | Regional anesthesiology |
| Intervention | Anesthesiology trainees and attending physicians are asked to obtain a supraclavicular view with one medium before a washout period and then repeat the exercise with the other medium. The view with each medium is saved and two blinded experts graded each view as: “proceed with the nerve block” or “not proceed with the nerve block”. If there is a disagreement between the two experts a third expert provided a tie-break. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Acceptable ultrasound image as deemed by the percentage of images that blinded expert reviewer answered “yes” to the question “Would you proceed with the block with this image?”. This will be measured just after image acquisition. |
| Key secondary outcome measure(s) |
Quality of ultrasound image measured by a visual analogue scale of 0-10 by a blinded expert reviewer just after image acquisition |
| Completion date | 29/05/2021 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | Anesthesiology trainee or attending at the Mount Sinai Hospital who completed all required peripheral nerve blocks required by the Accreditation Council for Graduate Medical Education |
| Key exclusion criteria | Subject refused after being explained study |
| Date of first enrolment | 05/03/2021 |
| Date of final enrolment | 28/05/2021 |
Locations
Countries of recruitment
- United States of America
Study participating centre
New York
10029
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Garrett Burnett (garrett.burnett@mountsinai.org). The study data will be kept for 6 months following the publication of the study. Data will include training level, prior use of saline as an ultrasound medium, comfort with supraclavicular blocks, time to obtain supraclavicular block, acceptability of ultrasound image, and quality of ultrasound image. Unidentified data will be shared with researchers inquiring for further analyses, collaboration or additional information if deemed acceptable by the Mount Sinai Institutional Review Board. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/04/2021: Trial's existence confirmed by the Institutional Review Board of the Mount Sinai School of Medicine.
