Assessment of the vertebral space for the insertion of a needle to inject the drug for spinal anesthesia: a volunteer-based study to assess the ability of the anesthetist to identify the space correctly
| ISRCTN | ISRCTN17536874 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17536874 |
- Submission date
- 14/03/2024
- Registration date
- 18/03/2024
- Last edited
- 18/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The intervertebral space (between two adjacent vertebrae in the spine) is estimated before performing spinal and epidural anaesthesia using the palpatory method (using hands). Ultrasound accurately identifies the desired intervertebral spaces, hence avoiding the wrong level of injection and avoiding damage to the spinal cord. The aim of this study is to compare the assessment of intervertebral level by palpation and ultrasound.
Who can participate?
Healthy volunteers aged 18 years and over and anaesthetists with various levels of experience
What does the study involve?
Anaesthetists with various levels of expertise will be asked to palpate the patient's back and to mark the space desired, and the chosen level will be noted. An ultrasound machine will be used by a trained researcher and the correlation between the landmark-estimated space and the ultrasound findings will be noted. Participants’ factors such as age, gender, BMI, and the presence of vertebral malformations (e.g. scoliosis) will be noted.
What are the possible benefits and risks of participating?
Possible benefits include the correct estimation of intervertebral spaces. There are no expected risks.
Where is the study run from?
King Hamad University Hospital (Bahrain)
When is the study starting and how long is it expected to run for?
January 2023 to March 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Surendranath Venkatesan, surendranath.venkatesan@khuh.org.bh
Contact information
Public, Scientific, Principal Investigator
Royal Medical Services
Building 2435, Road 2835
Block 228, PO Box 24343
Busaiteen
28
Bahrain
 ORCID ID |
0009-0001-4016-9957 |
|---|---|
| Phone | +973 (0)38894263 |
| surendranath.venkatesan@khuh.org.bh |
Study information
| Study design | Observational |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A study to evaluate the correlation between anatomical landmark ultrasound imaging estimation of intervertebral level |
| Study objectives | Palpation of intervertebral levels may not correctly estimate intervertebral spaces, especially when patients with specific characteristics, such as increased BMI, sclerosed interspinous ligaments and vertebral malformation such as scoliosis, where palpation of the iliac crests and vertebral spinous processes can be difficult. Whereas with ultrasound imaging, the actual intervertebral spaces can be visualized giving a more accurate estimation. Volunteers were recruited to allow anaesthetists to palpate the space manually and it was correlated by ultrasound estimation. |
| Ethics approval(s) |
Approved 28/03/2023, Institutional Review Board - King Hamad University Hospital (Building 2435, Road 2835 Block 228, PO Box 24343, Busaiteen, 228, Bahrain; +973 (0)17444444; khuh@khuh.org.bh), ref: 23-598 |
| Health condition(s) or problem(s) studied | Assessment of intervertebral space |
| Intervention | Verbal consent will be taken from the volunteer participants. Anaesthetists with various levels of expertise will be asked to palpate the patient's back and to mark the space desired, the chosen level will be noted. An ultrasound machine will be used by a trained researcher and the correlation between the landmark-estimated space and the ultrasound findings will be noted. Participants’ factors such as age, gender, BMI, and the presence of vertebral malformations (e.g. scoliosis) will be noted. |
| Intervention type | Other |
| Primary outcome measure | The correlation between anatomical palpation method of intervertebral space estimation and ultrasound estimation. The intervertebral space identified by participants on the two volunteers by the palpatory method was correlated with the ultrasound estimation of the intervertebral space. The difference or agreement between the two different methods was noted. Measured at a single timepoint. |
| Secondary outcome measures | Measured at a single timepoint: 1. The time taken to estimate by anatomical palpation by participants on volunteers and ultrasound estimation by a trained researcher. A timer was kept as a standard and time from beginning to completion of estimation of the intervertebral space was noted in seconds. 2. The effect of experience on correct estimation, noted from personal interviews with the participants. |
| Overall study start date | 10/01/2023 |
| Completion date | 31/03/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Willing volunteer 2. Adult volunteer (over 18 years of age) |
| Key exclusion criteria | 1. Age <18 years 2. Pregnant women 3. Back deformities |
| Date of first enrolment | 01/04/2023 |
| Date of final enrolment | 31/03/2024 |
Locations
Countries of recruitment
- Bahrain
Study participating centre
Block 228, PO Box 24343
Busaiteen
228
Bahrain
Sponsor information
Hospital/treatment centre
Royal Medical Services
Building 2435, Road 2835
Block 228, PO Box 24343
Busaiteen
228
Bahrain
| Phone | +973 (0)17444444 |
|---|---|
| khuh@khuh.org.bh | |
| Website | https://www.khuh.org.bh/en/about-khuh |
"ROR" |
https://ror.org/0538fxe03 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | Datasets generated during and/or analysed during the current study will be available upon request from Dr Surendranath Venkatesan (surendranath.venkatesan@khuh.org.bh). The type of data that will be shared: participants' level of experience, time taken to estimate by palpatory method and ultrasound method and volunteers' age, sex, weight and height will be shared. Dates of availability: From the last day of completion of study. Data is anonymised and numbered and the personal identities of both volunteers and participants are concealed. |
Editorial Notes
18/03/2024: Study's existence confirmed by the Institutional Review Board - King Hamad University Hospital.
