To Map Human Lower Thoracic Dermatomes by Epidural Block (LTDEP)

July 13, 2018 updated by: Liu Yong, Tongji Hospital

Observation Study of Thoracic Dermatomes

Significant differences exist among various dermatome maps. In addition, there were no anatomical landmarks to evaluate the dermatome at the back. The investigators aim to map the sensory innervations of lower thoracic nerves and find the dorsal landmarks to evaluate sensory innervations by epidural block. Patients undergoing urological surgery will receive epidural block. Fifty patients with superior border of complete sensory loss to ice from T9 to T12 (anterior median line) will be included in this study. The sensory loss to ice will be evaluated at midclavicular line, anterior axillary line, posterior axillary line, scapular line and posterior median line. The level of vertebrae will be identified and marked by ultrasound. The superior border of complete sensory loss to ice from anterior median line to posterior median line will be recorded for every patient. The dermatome map of T9 to T12 will be drawn. The landmarks of sensory innervations at posterior median line will be established using vertebrae.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background: The tract for percutaneous nephrolithotomy is typically established in the 11th intercostal space or in the subcostal area. According to Keegan and Garrett's dermatome map, the somatic pain could be controlled if the 11th and 12th the spinal nerve been blocked. However, the investigators found that if the 11th and the 12th spinal nerve had been blocked by evaluating the landmarks of ventral landmarks (xiphoid process , umbilicus and pubic symphysis), the somatic pain of percutaneous nephrolithotomy could not be controlled. In order to find the reason, the investigators compared the four main dermatome maps created by Henry Head, Foerster, Keegan and Lee. There are significant differences of dermatome among these maps. In addition, there were no landmarks to evaluate the dermatome at the back.

Objectives: To map the sensory innervations of lower thoracic nerves and find the dorsal landmarks to evaluate sensory innervations by epidural block.

Methods: Adult patients undergoing elective percutaneous nephrolithotomy, ureteroscopic lithotripsy, transuretheral resection of prostate and transuretheral resection of bladder tumor will receive epidural block with 0.5% ropivacaine. Complete Sensory loss to ice will be evaluated at anterior median line as soon as the surgery was completed. The superior border of complete sensory loss to ice will be identified by ventral landmaks (xiphoid process , umbilicus and pubic symphysis). Fifty patients with superior border of complete sensory loss to ice from T9 to T12 will be included in this study. The sensory loss to ice will be evaluated at anterior median line, midclavicular line, anterior axillary line, posterior axillary line, scapular line and posterior median line. The level of vertebrae will be identified and marked by ultrasound. The superior border of complete sensory loss to ice form anterior median line to posterior median line will be drawn and recorded for every patient. The dermatome map from T9 to T12 will be drawn. The landmarks of sensory innervations at posterior median line will be established using vertebrae..

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients scheduled for percutaneous nephtolithotomy, ureteroscopy lithotripsy, transurethral resection of bladder tumor or transurethral resection of the prostate
  • American Society of Anesthesiologists physical statusⅠ-Ⅲ
  • Informed consent

Exclusion Criteria:

  • Coagulopathy, on anticoagulants
  • History of surgery on spine
  • Spine deformity
  • A known allergy to the drugs being used
  • Tumer or infection at the site of puncture
  • refusal to participate in the study

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Epidural Block
Epidural block for patients undergoing urological surgery
Other: cold sensation method
Complete sensory loss to ice will be evaluated form anterior median line to posterior median line at the end of surgery.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Superior border of sensory block was assessed by cold sensation method
Time Frame: at the end of surgery
The sensory loss to ice will be evaluated at anterior median line, midclavicular line, anterior axillary line, posterior axillary line, scapular line and posterior median line. The level of vertebrae will be identified and marked by ultrasound. The upper border of complete sensory loss to ice form anterior median line to posterior median line will be drawn and recorded for every patient.
at the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tongji Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yong Liu, MD, Department of Anesthesiology,Tongji Hospital,Wuhan

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

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Der-201701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Damatomes of sensory loss to cold of each patient. Investigators can contact us by e-mail.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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