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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

50

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

  • 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

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
Intervention / Treatment
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

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

Tongji Hospital

Investigators

  • 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)

February 1, 2017

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

January 10, 2017

First Submitted That Met QC Criteria

January 11, 2017

First Posted (Estimate)

January 16, 2017

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 13, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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