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

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:
  • 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.
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:
  • 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.
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:
  • 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.
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:
  • Bupivacaine

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.

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

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.

Clinical Trials on Anesthesia, Spinal [E03.155.086.331]

Clinical Trials on Umbilicus

Subscribe