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Effect of the Height of the Operating Table During Spinal Anesthesia

NCT ID: NCT02373410

Last Updated: 2015-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-08-31

Brief Summary

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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

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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.

Conditions

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Anesthesia, Spinal [E03.155.086.331] Operating Tables [E07.325.662]

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

Umbilicus

Intervention Type PROCEDURE

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

Umbilicus Bupivacaine

Intervention Type DRUG

If freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups.

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.

Group Type ACTIVE_COMPARATOR

Lowest rib margin

Intervention Type PROCEDURE

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

Lowest rib margin Bupivacaine

Intervention Type DRUG

If freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups.

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.

Group Type ACTIVE_COMPARATOR

Xiphoid

Intervention Type PROCEDURE

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

Xiphoid Bupivacaine

Intervention Type DRUG

If freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups.

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.

Group Type ACTIVE_COMPARATOR

Nipple

Intervention Type PROCEDURE

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

Nipple Bupivacaine

Intervention Type DRUG

If freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups.

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Xiphoid

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

Intervention Type PROCEDURE

Nipple

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

Intervention Type PROCEDURE

Umbilicus Bupivacaine

If freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups.

Intervention Type DRUG

Lowest rib margin Bupivacaine

If freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups.

Intervention Type DRUG

Xiphoid Bupivacaine

If freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups.

Intervention Type DRUG

Nipple Bupivacaine

If freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups.

Intervention Type DRUG

Other Intervention Names

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Bupivacaine Bupivacaine Bupivacaine Bupivacaine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jinhee Kim, MD,PhD

Role: STUDY_DIRECTOR

Seoul National University Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam, Gyeonggido, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jinhee Kim, MD,PhD

Role: CONTACT

Phone: 82-31-787-7505

Email: [email protected]

Hyerim Kim, MD

Role: CONTACT

Phone: 82-10-7120-9110

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 24355831 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19707143 (View on PubMed)

Other Identifiers

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I-2014-6010

Identifier Type: -

Identifier Source: org_study_id