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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03022136
Other study ID # Der-201701
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2017
Est. completion date July 1, 2017

Study information

Verified date July 2018
Source Tongji Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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..


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date July 1, 2017
Est. primary completion date July 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 status?-?

- 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China Tongji Hospital Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

Greenberg SA. The history of dermatome mapping. Arch Neurol. 2003 Jan;60(1):126-31. — View 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. — View 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. Review. — View 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. Review. — View 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):496-50 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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