NCT02838056

Brief Summary

Traditionally, placement of the epidural catheter is based on hand feel of passing through the ligamentum flavum as well as "loss of resistance" while injecting the air through the needle. However, both are subjective and not necessarily encountered consistently. Moreover, the onset of sensory block is usually slow, thus making confirmation of catheter position a tough task and may delay the turnover of the operating room. The only way to confirm the catheter position objectively without delaying surgery is to find a reliable indicator within minutes of local anesthetic injection. In this study, we try to use the change of temperature in the big toe as a surrogate indicator of correct epidural catheterization.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

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
unknown

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

July 12, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

February 21, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

February 28, 2017

Status Verified

May 1, 2016

Enrollment Period

6 months

First QC Date

July 12, 2016

Last Update Submit

February 24, 2017

Conditions

Early Confirmation of Epidural Catheterization

Keywords

anesthesia, epiduralskin temperature

Outcome Measures

Primary Outcomes (1)

  • measurement of skin temperature change over big toe after epidural local anesthetic injection

    SPECTRUM 9000MB to detect lower limb color changes

    within 10 mins after injection

Secondary Outcomes (1)

  • measurement of skin sensation change between inguinal area to umbilicus

    within 15 mins after injection

Study Arms (1)

epidural injection

EXPERIMENTAL

epidural injection of 2% lidocaine 17 ml + 2 ml alfentanil (544 mcg x 2 = 1088 mcg) + 7% sodium bicarbonate 2.3 ml (1.9 mEq) + 0.1mg epinephrine (1:200000)

Drug: epidural injection

Interventions

epidural injectionDRUG

drug combination: 2% lidocaine 17 ml + 2 ml alfentanil (544 mcg x 2 = 1088 mcg) + 7% sodium bicarbonate 2.3 ml (1.9 mEq) + 0.1mg epinephrine (1:200000)

epidural injection

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body weight:50-90kg,
  • American Society of Anesthesiologists physical status classification I-II,
  • Under epidural anesthesia for surgery

You may not qualify if:

  • History of receiving lumbar surgery
  • Allergy to alfentanil ,xylocaine, bicarbonate
  • Trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University/Wan Fang Hospital

Taipei, Taiwan

RECRUITING

Related Publications (3)

  • Cherng CH, Wong CS, Ho ST. Epidural fentanyl speeds the onset of sensory block during epidural lidocaine anesthesia. Reg Anesth Pain Med. 2001 Nov-Dec;26(6):523-6. doi: 10.1053/rapm.2001.27852.

    PMID: 11707790BACKGROUND

  • Werdehausen R, Braun S, Hermanns H, Freynhagen R, Lipfert P, Stevens MF. Uniform distribution of skin-temperature increase after different regional-anesthesia techniques of the lower extremity. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):73-8. doi: 10.1016/j.rapm.2006.07.009.

    PMID: 17196496BACKGROUND

  • Coda BA, Brown MC, Schaffer R, Donaldson G, Jacobson R, Hautman B, Shen DD. Pharmacology of epidural fentanyl, alfentanil, and sufentanil in volunteers. Anesthesiology. 1994 Nov;81(5):1149-61. doi: 10.1097/00000542-199411000-00008.

    PMID: 7978473BACKGROUND

MeSH Terms

Interventions

Injections, Epidural

Intervention Hierarchy (Ancestors)

Injections, SpinalInjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Jui-An Lin, MD

    Taipei Medical University/Wan Fang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng-Feng Yang, MD

CONTACT

+886229307930eclectec@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2016

First Posted

July 20, 2016

Study Start

February 21, 2017

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

February 28, 2017

Record last verified: 2016-05

Locations

TW(1)