Early Detection of Epidural Onset by Temperature Change

Early Detection of the Effect of Epidural Local Anesthetic by Temperature Change on the Big Toe

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02838056

Enrollment

Registered

2016-07-20

Start date

2017-02-21

Completion date

2017-09-30

Last updated

2017-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Confirmation of Epidural Catheterization

Keywords

anesthesia, epidural, skin temperature

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.

Detailed description

Epidural anesthesia loading dose: 17ml 2% xylocaine + 2.3ml sodium bicarbonate + 2ml Rapifen (1088 mcg) + 0.1 mg epinephrine

Interventions

DRUGepidural injection

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)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 79 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
measurement of skin temperature change over big toe after epidural local anesthetic injection	within 10 mins after injection	SPECTRUM 9000MB to detect lower limb color changes

Secondary

Measure	Time frame	Description
measurement of skin sensation change between inguinal area to umbilicus	within 15 mins after injection	tested by alcohol sponge

Countries

Taiwan

Contacts

Primary ContactSheng-Feng Yang, MD

eclectec@hotmail.com+886229307930

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026