- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02373410
Effect of the Height of the Operating Table During Spinal Anesthesia
February 26, 2015 updated by: Seoul National University Hospital
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.
Study Overview
Status
Unknown
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 Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggido
-
Seongnam, Gyeonggido, Korea, Republic of, 463707
- Recruiting
- Seoul National University Bundang Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- undergoing elective surgery under spinal anesthesia
Exclusion Criteria:
- body mass index (BMI)>30
- history of spine operation or severe anatomical abnormalities of spine
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Umbilicus
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.
|
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
If freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups.
Other Names:
|
|
ACTIVE_COMPARATOR: Lowest rib margin
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.
|
The height of the operating table which set at the needle insertion point of anesthetists; the level of lowest rib margin
If freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups.
Other Names:
|
|
ACTIVE_COMPARATOR: Xiphoid
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.
|
The height of the operating table which set at the needle insertion point of anesthetists; the level of xiphoid
If freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups.
Other Names:
|
|
ACTIVE_COMPARATOR: Nipple
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.
|
The height of the operating table which set at the needle insertion point of anesthetists; the level of nipple
If freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The angle between the patient's skin and the spinal needle
Time Frame: during procedure
|
during procedure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
anesthesiologist's subjective discomfort
Time Frame: during procedure
|
during procedure
|
|
the degree of anesthesiologist's joint flexion
Time Frame: during procedure
|
during procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Jinhee Kim, MD,PhD, Seoul National University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Ajmal 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (ANTICIPATED)
August 1, 2015
Study Completion (ANTICIPATED)
August 1, 2015
Study Registration Dates
First Submitted
November 27, 2014
First Submitted That Met QC Criteria
February 26, 2015
First Posted (ESTIMATE)
February 27, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
February 27, 2015
Last Update Submitted That Met QC Criteria
February 26, 2015
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I-2014-6010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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