Anesthesia, Spinal [E03.155.086.331]NCT02373410
Effect of the Height of the Operating Table During Spinal Anesthesia
A study testing Umbilicus, Lowest rib margin and Xiphoid in people with Anesthesia, Spinal [E03.155.086.331] and Operating Tables [E07.325.662], run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to analyze the accuracy of needle insertion and the discomfort during different ergonomic conditions faced by anesthesiologists during spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia, Spinal [E03.155.086.331], Operating Tables [E07.325.662]
- What is being tested?
- Umbilicus, Lowest rib margin and Xiphoid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing elective surgery under spinal anesthesia
Who cannot join
- body mass index (BMI)>30
- history of spine operation or severe anatomical abnormalities of spine
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam, Gyeonggido, 463707
About this study
The purpose of this study is to analyze the accuracy of needle insertion and the discomfort during different ergonomic conditions faced by anesthesiologists during spinal anesthesia. In particular,the investigators intend to compare the angles between the patients' back and the inserted spinal needle in the coronal plane at different operating table heights.
Read the detailed description
Sixty patients will be recruited undergoing elective surgery under spinal anesthesia. The patients will be randomly allocated to one of four groups: Group U, L, X, and N. These acronyms indicate the heights of the operating table which set at the needle insertion point of anesthetists, namely the level of umbilicus, lowest rib margin, xiphoid process, and nipple in a standing posture. The angle between the patient's skin and the spinal needle will be measured by the protractor in the coronal and sagittal plane. The anesthesiologists will be asked to record the subjective general discomfort graded by Numeric Rating Scale. And the degree of neck, lower back, knee, and elbow flexion of the anesthesiologists will be measured by taking pictures during procedure.
- Being tested
- Umbilicus, Lowest rib margin, Xiphoid, Nipple, Umbilicus Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UmbilicusProcedure or surgery
Depending on the height of the operating table, the insertion angle of the spinal needles would be vary. The investigators intend to find the optimal angle and the height of the table to provide that.
The height of the operating table which set at the needle insertion point of anesthetists; the level of umbilicus
Lowest rib marginProcedure or surgery
The height of the operating table which set at the needle insertion point of anesthetists; the level of lowest rib margin
XiphoidProcedure or surgery
The height of the operating table which set at the needle insertion point of anesthetists; the level of xiphoid
NippleProcedure or surgery
The height of the operating table which set at the needle insertion point of anesthetists; the level of nipple
Umbilicus BupivacaineDrug
Also called Bupivacaine
If freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups.
Lowest rib margin BupivacaineDrug
Also called Bupivacaine
If freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups.
Xiphoid BupivacaineDrug
Also called Bupivacaine
If freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups.
Nipple BupivacaineDrug
Also called Bupivacaine
If freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups.
| Study group | Role | What they receive |
|---|---|---|
| Umbilicus | Experimental | The height of the operating table which set at the needle insertion point, is the level of umbilicus of the anesthesiologist in a standing posture. Receives: Procedure: Umbilicus; Drug: Umbilicus Bupivacaine |
| Lowest rib margin | Active comparator | The height of the operating table which set at the needle insertion point, is the level of lowest rib margin of the anesthesiologist in a standing posture. Receives: Procedure: Lowest rib margin; Drug: Lowest rib margin Bupivacaine |
| Xiphoid | Active comparator | The height of the operating table which set at the needle insertion point, is the level of xiphoid of the anesthesiologist in a standing posture. Receives: Procedure: Xiphoid; Drug: Xiphoid Bupivacaine |
| Nipple | Active comparator | The height of the operating table which set at the needle insertion point, is the level of nipple of the anesthesiologist in a standing posture. Receives: Procedure: Nipple; Drug: Nipple Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The angle between the patient's skin and the spinal needle
Measured: during procedure
Secondary outcomes (2)
anesthesiologist's subjective discomfort
Measured: during procedure
the degree of anesthesiologist's joint flexion
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startSep 2014
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, Spinal [E03.155.086.331]Studies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jinhee Kim, MD,PhD, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373410
- Sponsor's protocol ID
- I-2014-6010
- Status last verified
- Sep 2014
- First submitted
- 27 Nov 2014
- Last updated
- 27 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee HC, Yun MJ, Hwang JW, Na HS, Kim DH, Park JY. Higher operating tables provide better laryngeal views for tracheal intubation. Br J Anaesth. 2014 Apr;112(4):749-55. doi: 10.1093/bja/aet428. Epub 2013 Dec 18.
PubMed 24355831Ajmal M, Power S, Smith T, Shorten GD. An ergonomic task analysis of spinal anaesthesia. Eur J Anaesthesiol. 2009 Dec;26(12):1037-42. doi: 10.1097/EJA.0b013e3283317dc9.
PubMed 19707143
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Height of the Operating Table During Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT02373410
- Acronym / sponsor ID
- I-2014-6010
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 27 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to analyze the accuracy of needle insertion and the discomfort during different ergonomic conditions faced by anesthesiologists during spinal anesthesia. In particular,the investigators intend to compare the angles between the patients' back and the inserted spinal needle in the coronal plane at different operating table heights.
Detailed description
Sixty patients will be recruited undergoing elective surgery under spinal anesthesia. The patients will be randomly allocated to one of four groups: Group U, L, X, and N. These acronyms indicate the heights of the operating table which set at the needle insertion point of anesthetists, namely the level of umbilicus, lowest rib margin, xiphoid process, and nipple in a standing posture. The angle between the patient's skin and the spinal needle will be measured by the protractor in the coronal and sagittal plane. The anesthesiologists will be asked to record the subjective general discomfort graded by Numeric Rating Scale. And the degree of neck, lower back, knee, and elbow flexion of the anesthesiologists will be measured by taking pictures during procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Umbilicus | Experimental | Procedure: Umbilicus, Drug: Umbilicus BupivacaineThe height of the operating table which set at the needle insertion point, is the level of umbilicus of the anesthesiologist in a standing posture. |
| Lowest rib margin | Active comparator | Procedure: Lowest rib margin, Drug: Lowest rib margin BupivacaineThe height of the operating table which set at the needle insertion point, is the level of lowest rib margin of the anesthesiologist in a standing posture. |
| Xiphoid | Active comparator | Procedure: Xiphoid, Drug: Xiphoid BupivacaineThe height of the operating table which set at the needle insertion point, is the level of xiphoid of the anesthesiologist in a standing posture. |
| Nipple | Active comparator | Procedure: Nipple, Drug: Nipple BupivacaineThe height of the operating table which set at the needle insertion point, is the level of nipple of the anesthesiologist in a standing posture. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- undergoing elective surgery under spinal anesthesia
Key exclusion criteria (2 listed)
- body mass index (BMI)>30
- history of spine operation or severe anatomical abnormalities of spine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UmbilicusDepending on the height of the operating table, the insertion angle of the spinal needles would be vary. The investigators intend to find the optimal angle and the height of the table to provide that. The height of the operating table which set at the needle insertion point of anesthetists; the level of umbilicus | Procedure or surgery | Umbilicus |
| Lowest rib marginThe height of the operating table which set at the needle insertion point of anesthetists; the level of lowest rib margin | Procedure or surgery | Lowest rib margin |
| XiphoidThe height of the operating table which set at the needle insertion point of anesthetists; the level of xiphoid | Procedure or surgery | Xiphoid |
| NippleThe height of the operating table which set at the needle insertion point of anesthetists; the level of nipple | Procedure or surgery | Nipple |
| Umbilicus BupivacaineAlso: BupivacaineIf freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups. | Drug | Umbilicus |
| Lowest rib margin BupivacaineAlso: BupivacaineIf freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups. | Drug | Lowest rib margin |
| Xiphoid BupivacaineAlso: BupivacaineIf freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups. | Drug | Xiphoid |
| Nipple BupivacaineAlso: BupivacaineIf freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups. | Drug | Nipple |
Primary outcome
The angle between the patient's skin and the spinal needle
Time frame: during procedure
2 secondary outcomes
anesthesiologist's subjective discomfort
Time frame: during procedure
the degree of anesthesiologist's joint flexion
Time frame: during procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2015.
- Background: PubMed 24355831Lee HC, Yun MJ, Hwang JW, Na HS, Kim DH, Park JY. Higher operating tables provide better laryngeal views for tracheal intubation. Br J Anaesth. 2014 Apr;112(4):749-55. doi: 10.1093/bja/aet428. Epub 2013 Dec 18.
- Background: PubMed 19707143Ajmal M, Power S, Smith T, Shorten GD. An ergonomic task analysis of spinal anaesthesia. Eur J Anaesthesiol. 2009 Dec;26(12):1037-42. doi: 10.1097/EJA.0b013e3283317dc9.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinhee Kim, MD,PhD study director
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Umbilicus, Lowest rib margin and Xiphoid in people with Anesthesia, Spinal [E03.155.086.331] and Operating Tables [E07.325.662], run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinhee Kim, MD,PhD (82-31-787-7505, shm@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The angle between the patient's skin and the spinal needle (time frame: during procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02373410, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2015.