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Early Detection of Epidural Onset by Temperature Change

T

Taipei Medical University

Status

Unknown

Conditions

Early Confirmation of Epidural Catheterization

Treatments

Drug: epidural injection

Study type

Interventional

Funder types

Other

Identifiers

NCT02838056
201505007

Details and patient eligibility

About

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.

Full description

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

Enrollment

40 estimated patients

Sex

All

Ages

20 to 79 years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

epidural injection
Experimental group
Description:
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)
Treatment:
Drug: epidural injection

Trial contacts and locations

1

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Central trial contact

Sheng-Feng Yang, MD

Data sourced from clinicaltrials.gov

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