NCT03022136

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 16, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

5 months

First QC Date

January 10, 2017

Last Update Submit

July 13, 2018

Conditions

Keywords

epidural blockdermatomehumanspinal nervethoracic

Outcome Measures

Primary Outcomes (1)

  • 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.

    at the end of surgery

Study Arms (1)

Epidural Block

EXPERIMENTAL

Epidural block for patients undergoing urological surgery

Other: cold sensation method

Interventions

Complete sensory loss to ice will be evaluated form anterior median line to posterior median line at the end of surgery.

Epidural Block

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

Related Publications (6)

  • 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.

  • 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.

  • Greenberg SA. The history of dermatome mapping. Arch Neurol. 2003 Jan;60(1):126-31. doi: 10.1001/archneur.60.1.126.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Urologic Diseases

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Yong Liu, MD

    Department of Anesthesiology,Tongji Hospital,Wuhan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 16, 2017

Study Start

February 1, 2017

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

July 17, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will share

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

Locations