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Early Detection of Epidural Onset by Temperature Change

NCT ID: NCT02838056

Last Updated: 2017-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-21

Study Completion Date

2017-09-30

Brief Summary

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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

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

Conditions

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Early Confirmation of Epidural Catheterization

Keywords

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anesthesia, epidural skin temperature

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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epidural injection

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)

Group Type EXPERIMENTAL

epidural injection

Intervention Type DRUG

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)

Interventions

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epidural 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)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University WanFang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jui-An Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University/Wan Fang Hospital

Locations

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Taipei Medical University/Wan Fang Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Sheng-Feng Yang, MD

Role: CONTACT

Phone: +886229307930

Email: [email protected]

Facility Contacts

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Sheng-Feng Yang, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 11707790 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17196496 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7978473 (View on PubMed)

Other Identifiers

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201505007

Identifier Type: -

Identifier Source: org_study_id