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

Primary Purpose

Urological Disease, Anesthesia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
cold sensation method
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Urological Disease focused on measuring epidural block, dermatome, human, spinal nerve, thoracic

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tongji Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Epidural Block

Arm Description

Epidural block for patients undergoing urological surgery

Outcomes

Primary Outcome Measures

Superior border of sensory block was assessed by cold sensation method
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.

Secondary Outcome Measures

Full Information

First Posted
January 10, 2017
Last Updated
July 13, 2018
Sponsor
Tongji Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03022136
Brief Title
To Map Human Lower Thoracic Dermatomes by Epidural Block
Acronym
LTDEP
Official Title
Observation Study of Thoracic Dermatomes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
July 1, 2017 (Actual)
Study Completion Date
July 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urological Disease, Anesthesia
Keywords
epidural block, dermatome, human, spinal nerve, thoracic

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epidural Block
Arm Type
Experimental
Arm Description
Epidural block for patients undergoing urological surgery
Intervention Type
Other
Intervention Name(s)
cold sensation method
Intervention Description
Complete sensory loss to ice will be evaluated form anterior median line to posterior median line at the end of surgery.
Primary Outcome Measure Information:
Title
Superior border of sensory block was assessed by cold sensation method
Description
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.
Time Frame
at the end of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Liu, MD
Organizational Affiliation
Department of Anesthesiology,Tongji Hospital,Wuhan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Damatomes of sensory loss to cold of each patient. Investigators can contact us by e-mail.
Citations:
PubMed Identifier
10398478
Citation
Head H, Campbell AW, Kennedy PG. The pathology of Herpes Zoster and its bearing on sensory localisation. Rev Med Virol. 1997 Sep;7(3):131-143. doi: 10.1002/(sici)1099-1654(199709)7:33.0.co;2-7. No abstract available.
Results Reference
result
PubMed Identifier
15271730
Citation
Wolff AP, Wilder Smith OH, Crul BJ, van de Heijden MP, Groen GJ. Lumbar segmental nerve blocks with local anesthetics, pain relief, and motor function: a prospective double-blind study between lidocaine and ropivacaine. Anesth Analg. 2004 Aug;99(2):496-501, table of contents. doi: 10.1213/01.ANE.0000122268.70154.A9.
Results Reference
result
PubMed Identifier
12533100
Citation
Greenberg SA. The history of dermatome mapping. Arch Neurol. 2003 Jan;60(1):126-31. doi: 10.1001/archneur.60.1.126.
Results Reference
result
PubMed Identifier
18470936
Citation
Lee MW, McPhee RW, Stringer MD. An evidence-based approach to human dermatomes. Clin Anat. 2008 Jul;21(5):363-73. doi: 10.1002/ca.20636.
Results Reference
result
PubMed Identifier
21628826
Citation
Downs MB, Laporte C. Conflicting dermatome maps: educational and clinical implications. J Orthop Sports Phys Ther. 2011 Jun;41(6):427-34. doi: 10.2519/jospt.2011.3506. Epub 2011 May 31.
Results Reference
result
PubMed Identifier
23824984
Citation
Ladak A, Tubbs RS, Spinner RJ. Mapping sensory nerve communications between peripheral nerve territories. Clin Anat. 2014 Jul;27(5):681-90. doi: 10.1002/ca.22285. Epub 2013 Jul 3.
Results Reference
result

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To Map Human Lower Thoracic Dermatomes by Epidural Block

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