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Effect of the Height of the Operating Table During Spinal Anesthesia

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ClinicalTrials.gov Identifier: NCT02373410
Recruitment Status : Unknown
Verified September 2014 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : February 27, 2015
Last Update Posted : February 27, 2015
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Anesthesia, Spinal [E03.155.086.331] Operating Tables [E07.325.662] Procedure: Umbilicus Procedure: Lowest rib margin Procedure: Xiphoid Procedure: Nipple Drug: Umbilicus Bupivacaine Drug: Lowest rib margin Bupivacaine Drug: Xiphoid Bupivacaine Drug: Nipple Bupivacaine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Diagnostic
Official Title: Effect of the Height of the Operating Table During Spinal Anesthesia
Study Start Date : September 2014
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : August 2015

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.
Procedure: Umbilicus

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


Drug: Umbilicus Bupivacaine
If freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups.
Other Name: Bupivacaine

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.
Procedure: Lowest rib margin
The height of the operating table which set at the needle insertion point of anesthetists; the level of lowest rib margin

Drug: Lowest rib margin Bupivacaine
If freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups.
Other Name: Bupivacaine

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.
Procedure: Xiphoid
The height of the operating table which set at the needle insertion point of anesthetists; the level of xiphoid

Drug: Xiphoid Bupivacaine
If freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups.
Other Name: Bupivacaine

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.
Procedure: Nipple
The height of the operating table which set at the needle insertion point of anesthetists; the level of nipple

Drug: Nipple Bupivacaine
If freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups.
Other Name: Bupivacaine




Primary Outcome Measures :
  1. The angle between the patient's skin and the spinal needle [ Time Frame: during procedure ]

Secondary Outcome Measures :
  1. anesthesiologist's subjective discomfort [ Time Frame: during procedure ]
  2. the degree of anesthesiologist's joint flexion [ Time Frame: during procedure ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373410


Contacts
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Contact: Jinhee Kim, MD,PhD 82-31-787-7505 shm@snubh.org
Contact: Hyerim Kim, MD 82-10-7120-9110 kimhl911@daum.net

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggido, Korea, Republic of, 463707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Director: Jinhee Kim, MD,PhD Seoul National University Hospital
Publications:
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02373410    
Other Study ID Numbers: I-2014-6010
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: February 27, 2015
Last Verified: September 2014
Additional relevant MeSH terms:
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Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents